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ORIGINAL RESEARCH

A randomized controlled trial of the effects of nursing care based on

Watson’s Theory of Human Caring on distress, self-efficacy and

adjustment in infertile women

_Ilkay Arslan- €Ozkan, H€ulya Okumus� & Kadriye Buldukoğlu

Accepted for publication 23 November 2013

Correspondence to _I. Arslan- €Ozkan:

e-mail: [email protected]

_Ilkay Arslan- €Ozkan BSN PhD

Assistant Professor

Department of Obstetric and Gynecological

Nursing, Nursing Faculty, Akdeniz

University, Antalya, Turkey

H€ulya Okumus� BSN PhD Professor

Department of Obstetric and Gynecological

Nursing, School of Nursing, Sifa University,

Izmir, Turkey

Kadriye Buldukoğlu BSN PhD

Professor

Department of Psychiatric and Mental

Health Nursing, Nursing Faculty, Akdeniz

University, Antalya, Turkey

ARSLAN - €OZKAN _I. , OKUMUS� H. & BULDUKO �GLU K . ( 2 0 1 4 ) A randomized

controlled trial of the effects of nursing care based on Watson’s Theory of Human

Caring on distress, self-efficacy and adjustment in infertile women. Journal of

Advanced Nursing 70(8), 1801–1812. doi: 10.1111/jan.12338

Abstract Aims. To investigate the effects of nursing care based on the Theory of Human

Caring on distress caused by infertility, perceived self-efficacy and adjustment

levels.

Background. Infertility leads to individual, familial and social problems. Nursing

care standards for women affected by infertility have yet to emerge.

Design. A randomized controlled trial.

Methods. This study was conducted from May 2010–February 2011, with 105

Turkish women with infertility (intervention group: 52, control group: 53). We

collected data using the Infertility Distress Scale, the Turkish-Infertility Self

Efficacy Scale Short Form and the Turkish-Fertility Adjustment Scale. The

intervention group received nursing care based on the Theory of Human

Caring. Data were analysed using t-tests, chi-square tests and intention-to-treat

analyses.

Results. The intervention and control groups significantly differed with regard to

infertility distress, self-efficacy and adjustment levels. The intervention group’s

mean self-efficacy score increased by seven points and adjustment score decreased

by seven points (in a positive direction). In addition, there was a significant

reduction in infertility distress scores in the intervention group, but there was no

change in the control group.

Conclusion. Nursing care based on the Theory of Human Caring decreased the

negative impact of infertility in women receiving infertility treatment and

increased self-efficacy and adjustment.

Keywords: adjustment, distress, infertility, nursing care, self-efficacy, Watson’s

Theory of Human Caring

© 2013 John Wiley & Sons Ltd 1801

Introduction

Infertility affects 10–15% of couples (Cousineau & Domar

2007). Nursing care of women with infertility should

address their physiological, psychological, emotional and

social needs (Beji 2001, Hammond 2001, Devine 2003),

but the appropriate care framework has yet to be clearly

defined (Karaniso�glu & Yazıcı 2009).

Watson’s Theory of Human Caring

It is essential to base nursing care on an established theoret-

ical framework to improve treatment outcomes (Fawcett

2005, Gigliotti 2008). In the present study, we used

Watson’s Theory of Human Caring as a guide to under-

stand women with infertility, develop a care framework

and form a nursing intervention.

The Theory of Human Caring is based on the idea that

humans cannot be treated as objects; they cannot be sepa-

rated from their self, others, nature and the universe

(Watson 2008). The Theory of Human Caring also states

that caring entails being present, attentive, conscious and

intentional. Nursing is centred on helping the patient

achieve a higher degree of harmony in the mind, body

and soul through a transpersonal caring relationship.

Watson believes that love, compassion and forgiveness

from patients and nurses are essential to the healing pro-

cess. The conceptual elements of the Theory of Human

Caring include the caritas process, the transpersonal car-

ing relationship, caring moments and caring occasions

and caring–healing modalities (Watson 2012). Various

studies have established that the Theory of Human Caring

can make nursing care more efficient and aware, and

improve care outcomes (Carson 2004, Childs 2006, Dren-

kard 2008).

Background

Infertility is difficult to accept (Noorbala et al. 2008).

Researchers have established that infertility decreases qual-

ity of life (Aliyeh & Laya 2007, Valsangkar et al. 2011)

and may lead to loneliness (Kavlak & Saruhan 2002), emo-

tional distress, stress ( €Ozkan & Baysal 2006, Boivin et al.

2011), depression, anxiety (G€ulseren et al. 2006, Noorbala

et al. 2008, Kazandı et al. 2011), loss of control, stigmati-

zation (Cousineau & Domar 2007) and marital discord

(T€uzer et al. 2010).

Such consequences become more pronounced as the infer-

tility treatment progresses (Boivin & Schmidt 2005, Boivin

et al. 2011). Nurses working in the field of infertility aim

to help such individuals cope with these adverse effects and

increase their well-being (Payne & Goedeke 2007). There-

fore, it is crucial to be able to determine the degree to

which women are affected by their infertility, as reflected

by their self-efficacy and adjustment.

Self-efficacy refers to an individual’s confidence in his or

her ability to achieve a task or goal – the stronger people’s

self-efficacy is, the greater the effort they will exert to

achieve their desired goal (Bandura 1998). Because per-

ceived self-efficacy enables an individual to manage self-

care, make correct decisions influencing their health and

exhibit behaviour consistent with these decisions, it is a key

concept in nursing (Sousa et al. 2005). Cousineau et al.

(2006) assert that perceived self-efficacy also influences

women’s abilities to cope with infertility. It has been deter-

mined that infertility, together with its treatment processes,

decreases perceived self-efficacy in women (Domar et al.

2000, Venkatesan 2005).

Adjustment in women with infertility has been defined as

the ability of individuals to maintain their attitude towards

the probability of not having children in behavioural,

Why is this research needed?

● Infertility affects 10–15% of couples of reproductive age and leads to individual, familial and social problems.

● The framework of nursing care for infertility nurses is presently undefined.

● Basing nursing care on a model and providing informed care could improve care outcomes.

What are the key findings?

● This research provides important findings about nursing care based on Watson’s Theory of Human Caring for

women receiving infertility treatment:

● It decreased distress. ● It increased perceived self-efficacy and adjustment.

How should the findings be used to influence policy/ practice/research/education?

● Nurses should consider using Watson’s Theory of Human Caring when caring for women receiving infertility treatment.

● Future research should explore the experience of women receiving nursing care based on Watson’s Theory of

Human Caring.

● Infertility nurses need to increase their knowledge of Wat- son’s Theory of Human Caring, caritas processes and

transpersonal caring–healing modalities. An educational

programme based on these aspects should be available for

nurses’ use in clinics.

1802 © 2013 John Wiley & Sons Ltd

_I. Arslan- €Ozkan et al.

cognitive and emotional terms (Glover et al. 1999, Verhaak

et al. 2005). Adjustment and perceived self-efficacy in infer-

tile women have important effects on their attitudes and

during treatment.

Psychosocial support programmes increase perceptions

of self-efficacy, adjustment levels and psychosocial

well-being of women with infertility (Domar et al. 2000,

Deborah et al. 2001, Hosaka et al. 2002, Emery et al.

2003, Lee 2003, Lemmens et al. 2004, de Klerk et al. 2005,

Chan et al. 2006, Cox et al. 2006, Cousineau et al. 2008).

Nevertheless, these studies lack standardization in interven-

tions and methods, leading to the necessity for further

research on this issue (Boivin 2003, Wischmann 2008). To

our knowledge, no study has investigated the influence of

nursing care on the psychosocial effects of infertility,

perceived self-efficacy and adjustment in women with

infertility.

The study

Aims

The aims of this study were to investigate the effect of

nursing care based onWatson’s Theory of Human Caring on:

• women’s infertility-related distress, • women’s infertility-related perceived self-efficacy and • women’s infertility-related adjustment.

Hypotheses

(1) Infertility distress levels will be lower in the intervention

group than in the control group.

(2) Perceived self-efficacy will be higher in the intervention

group than in the control group.

+

Excluded (n = 262)

Declined to participate (n = 12) Did not receive treatment (n = 165) Did not meet inclusion criteria (n = 85)

Lost to follow-up (n = 8) Discontinued intervention n = 3 Treatment cancelled n = 4 Referred to another center for treatment n = 1

Lost to follow-up (n = 7) Discontinued intervention n = 2 Treatment cancelled n = 3 Referred to another center for treatment n = 2

Analyzed (n = 52) Excluded from analysis (n = 0)

Analyzed (n = 53) Excluded from analysis (n = 0)

Randomization (n = 120)

Assessed for eligibility (n = 382)

Routine nursing careRoutine nursing careNursing care based on Theory of human caring

A na

ly si

s E

nr ol

m en

t A

llo ca

tio n

F ol

lo w

-U p

Intervention Group (n = 60) Control Group (n = 60)

Figure 1 CONSORT diagram showing participant flow through the study.

© 2013 John Wiley & Sons Ltd 1803

JAN: ORIGINAL RESEARCH Watson’s Theory of Human Caring at infertile women’s care: a RCT

(3) Adjustment to infertility will be higher in the interven-

tion group than in the control group.

Design

This study was a prospective, randomized controlled trial

using a pre-test–posttest design. Figure 1 is the CONSORT

(Consolidated Standards of Reporting Trials) (Schulz et al.

2010) flow diagram of this study.

Participants

The clinical trial was conducted at a university hospital infer-

tility centre in Antalya, Turkey. In Turkey, couples are legally

required to be married to commence infertility treatment.

Inclusion

The inclusion criteria were as follows: (i) primary infertility;

(ii) between the ages of 18–45; and (iii) ability to speak,

read and write in Turkish.

Exclusion

The exclusion criteria were as follows: (i) secondary infertil-

ity; (ii) being diagnosed with a chronic disease; (iii) being

under the age of 18 or over the age of 45; and (iv) insuffi-

cient Turkish language skills and/or being a foreign national.

Sample size

In the original study of psychoeducational support

(Cousineau et al. 2008), the mean change in self-efficacy for

the intervention and control groups was 55�91 (SD 15�63) and 52�14 (SD 20�32), respectively. This gives an effect size of 0�05. To detect a standardized difference of 4�69 between the two groups, with 80% power and an alpha of 0�05 (two- sided), 120 participants needed to be included in the analy-

sis. Our study concluded with 52 people in the experiment

group and 53 participants in control group, after excluding

dropouts. At the end of the investigation, using mean scale

scores, standard deviations and tests in independent groups,

effect size was calculated and found to be strong at 0�8 (http://danielsoper.com/statcalc3/calc.aspx?id=49).

Randomization and blinding

Simple randomization was performed by a statistician using

SAS version 8�2 (SAS Institute 2001). A sealed envelope method was used in randomization; half of the women

were randomly assigned to the intervention group (n = 60)

and the other half to the control group (n = 60). Partici-

pants were blinded to treatment allocation. The investigator

delivered the intervention and, therefore, could not be

blinded to allocation.

Intervention

In the present study, the intervention group was given

Watson’s Theory of Human Caring-based nursing care

alongside routine nursing care, while the control group

received solely routine nursing care. First, the researchers

adapted the Theory of Human Caring to the study and

determined the 10 caritas process. Watson (2008) explained

that the word caritas originates from the Greek vocabulary,

meaning to cherish and to give special loving attention. Ca-

ritas makes more explicit the connection between caring

and love and human living processes. Caritas refers to the

way in which nurses approach their patients. The 10 caritas

processes are includes: (1) altruistic values and loving kind-

ness; (2) faith, hope and honour; (3) being sensitive to self

and others; (4) helping, trusting, caring relationships; (5)

promoting and accepting feelings; (6) problem-solving

methods; (7) teaching and learning; (8) creating a healing

environment; (9) assisting with human needs; (10) openness

to mystery and allowing miracles (Watson 2008).

The researchers debated whether the caritas process

should be considered in separate parts, or as a whole.

Nurses working in an infertility centre, nursing academic

personnel specialized in infertility and Dr. Jean Watson

were consulted. It was finally decided that caritas processes

4, 5, 6 and 7 would be used. The objectives of the caritas

processes used the interviews are listed in Table 1.

Table 1 The objectives of caritas processes used in the inter- views.

Caritas processes Objective

Caritas 4 ‘Developing and sustaining a

helping-trusting caring relationship

(helping-trusting relationship)’

Initiating interaction

and communication

Caritas 5 ‘Being present to and

supportive of, the expression of positive

and negative feelings (expressing

feelings)’

Determining levels of

distress of infertility,

self-efficacy and

adjustment

Caritas 6 ‘Creative use of self and all

ways of knowing as part of the caring

process; engage in the artistry of caritas

nursing (problem-solving)’

Achieving solutions to

problems of influence,

self-efficacy and

adjustment problems

Caritas 7 ‘Engaging in a genuine

teaching-learning experience that

attends to the unity of being and

subjective meaning; attempting to stay

within the other’s frame of reference

(teaching-learning)’

Teaching and applying

relaxation exercises to

enhance coping

1804 © 2013 John Wiley & Sons Ltd

_I. Arslan- €Ozkan et al.

The researchers developed a semi-structured nursing care

programme to be used as a guide during interviews. For

reliability and validity checks, the programme was trans-

lated into English and was sent to Dr. Jean Watson by

email for her expert opinion. In line with her suggestions,

the programme was revised and reached its final form.

A nursing care programme was carried out together with

infertility treatments. The IVF treatments take 14–18 days

and women come every two to three days. The nursing care

programme was conducted through four transpersonal

interviews when the women came to the infertility centre.

Interviews lasted 45–90 minutes. Interviews were recorded

briefly in notes taken by the investigator. After each inter-

view, the investigator prepared the plan for the next inter-

view based on her notes; in this way, interviews were

individualized according to participants’ specific needs.

Each interview was organized according to caritas pro-

cesses from the Theory of Human Caring. Interview nurse

attributes included active listening, empathy, touching,

expressions of their previous experience with infertility, pro-

viding social support, promoting and accepting positive and

negative feelings, encouragement, empowerment, motiva-

tion and positive thinking processes. Some sample phrases

from the interview guide are: ‘Could you tell me about the

state of your infertility, about your efforts towards preg-

nancy?’ (open-ended question); ‘Will you please share with

me what you went through since you were told that you are

unable to be pregnant?’ (exploratory); ‘Now, I am listening

to you’ (encouraging); and ‘I see, this has made you feel

rather poorly’ (empathetic). In this nursing care programme,

some of the caring–healing modalities recommended by

Watson (2012) were chosen, such as intentional conscious

use of visual modalities (Table 2).

We developed a teaching–learning plan and prepared a

booklet for teaching relaxation exercises such deep breathing,

progressive muscular relaxation and visualization. Women

were trained on relaxation exercises along with a music CD

and a booklet and were told to practise at home. At the end

of interviews, relaxation exercises were carried out with

women accompanied by relaxing music, candlelight and lav-

ender and rose scents. After each interview, women had the

option of receiving a back massage for 5–10 minutes.

In addition, interview nurse recommended that the

women keep a diary. They were told that they could bring

their diaries to interviews and that their diaries could be

read together at sessions to evaluate their experiences.

A card including the interviewer’s contact information

and a description of the study was given to the women.

During the study, communication was maintained in person

when the women came to the infertility centre and/or by

telephone or email.

Control condition

Control group participants received routine nursing care

but did not access the relaxation techniques, music, or

booklet. Their informed consent was obtained on the day

they started their IVF treatment. Participants were given

contact cards and, after they opened the envelopes, we

planned their interview schedules. Following the final tests,

they received training on relaxation exercises, a music CD

and an exercise booklet.

Data collection

Data were collected between May 2010–February 2011.

Both groups completed a sociodemographic data form, and

pre-test measures, at the onset of the study. At the end of

treatment, they were administered posttest measures.

Instruments

Sociodemographic data form

This is a form including 13 questions developed by the

investigators to obtain data on participants’ fertility and

sociodemographic characteristics.

Infertility Distress Scale

The Infertility Distress Scale (IDS), developed by Aky€uz et al.

(2008), describes how individuals feel about themselves with

regard to their infertility and their emotional state. It has 21

items, with total scores ranging between 21–84. High scores

indicate that the negative influence of infertility is high. In the

original study, Cronbach’s alpha = 0�93; in the present study, Cronbach’s alpha = 0�90.

Table 2 Caring–healing modalities used in study.

Transpersonal caring–

healing modalities Modalities used in the study

Auditory modalities Using music to relax: music without lyrics,

voices of nature, flute sounds

Visual modalities Creating a semi-dark environment during

relaxation exercises, using candles

Olfactory modalities Refreshing the air in interview room,

breathing clean air

Using deep breathing exercises

Tactile modality Back massage

Touching with hands

Mental-cognitive

modalities

Progressive muscular relaxation exercises,

visualization

© 2013 John Wiley & Sons Ltd 1805

JAN: ORIGINAL RESEARCH Watson’s Theory of Human Caring at infertile women’s care: a RCT

Turkish Infertility Self-Efficacy Scale, Short Form (TISE-SF)

The Infertility Self-Efficacy Scale (ISE) was developed by

Cousineau et al. (2006) to evaluate how individuals per-

ceive their self-efficacy in terms of their cognitive, emo-

tional and behavioural coping skills with respect to

infertility. Cousineau et al. developed a short form of the

scale (ISE-SF) with 10 items (a = 0�94). The short form was adapted to the Turkish context. The Cronbach’s alpha of

the Turkish version of the Infertility Self-Efficacy Scale,

Short Form (TISE-SF) was 0�78 (Arslan-Ozkan et al. 2013). Scores on the TISE-SF range between 8–32. Higher scores

indicate greater perceived self-efficacy.

Turkish Version of the Fertility Adjustment Scale (T-FAS)

The Fertility Adjustment Scale (FAS; Glover et al. 1999) was

developed to standardize the measurement of psychological

adjustment to infertility. The FAS considers adjustment as a

heterogeneous concept with cognitive, behavioural and

emotional aspects (Glover et al. 1999). The original scale

includes 12 items (a = 0�85). The Turkish version of FAS (T- FAS) has 10 items. Internal consistency of the T-FAS was

0�77 (Okumus� & Arslan-Ozkan 2012). Scores on the FAS range between 10–40, with a high score indicating of inade-

quate adjustment.

Ethical considerations

Research Ethics Committee approval was obtained from

two ethics committees: one from the School of Nursing (the

official sponsor of the research) and the other from the Fac-

ulty of Medicine (the proprietor of the clinic where the data

were collected). Additionally, corporate approvals were

obtained from the university hospital and the infertility cen-

tre where the participants were recruited. Finally, an

informed consent form was given to all participants.

Data analysis

SPSS statistical package (version 18.0; SPSS, Inc., Chicago,

IL, USA) was used to analyse the data. To evaluate the reli-

ability of the scales, their Cronbach’s alpha coefficients

were determined. Pre-test and posttest scores were obtained

from scales and were analysed with regard to means, stan-

dard deviations, ranges and t-tests.

We determined statistical methods after assessing the

shape of the data distribution. For pre-test and posttest

comparisons on infertility distress, infertility self-efficacy

and adjustment between the intervention and control

groups, a two-sample t-test was used.

Table 3 Demographic characteristics of intervention and control groups (n = 105).

Variable

Intervention

group

Control

group

v2 Pn (52) % n (53) %

Age

19–25 9 17�3 9 17�0 0�04 0�66 26–35 33 63�5 33 62�3 36–45 10 19�2 11 20�7

Education status

Literate and primary

school

20 38�5 20 37�7 0�35 0�59

Secondary school 10 19�2 10 18�9 High school 5 9�6 7 13�2 University or over 17 32�7 16 30�2

Marriage (years)

1–3 13 25�0 23 43�4 7�29 0�71 3�5–5 18 34�6 8 15�1 5�5–9 13 25�0 8 15�1 9�5 or over 8 15�4 14 26�4

Employment status

Working 39 75�0 36 67�9 2�77 0�69 Not working 13 25�0 17 32�1

Income (TL)*

Income less than

expenditure

16 30�8 14 26�4 1�27 0�50

Income equal to

expenditure

31 59�6 30 56�6

Expenditure more

than income

5 9�6 9 17�0

Meeting treatment expenses

Independently 4 7�7 6 11�3 0�41 0�54 Aided by social

security

48 92�3 47 88�7

Place of residence

City 30 57�7 32 60�4 0�08 0�68 Town and village 22 42�3 21 39�6

Characteristics related to infertility

Time from the diagnosis (years)

Under 3 16 30�8 24 45�2 6�89 0�77 3–6 23 44�2 11 20�8 Over 6 13 25�0 18 34�0

Duration of treatment (years)

Under 3 33 63�5 32 60�4 0�52 0�95 3–6 9 17�3 12 22�6 Over 6 10 19�2 9 17�0

Previous ART

COH

Administered 27 51�9 27 50�9 0�01 1�00 Not administered 25 48�1 26 49�1

IUI

Administered 25 48�1 22 41�5 0�46 0�42 Not administered 27 51�9 31 58�5

IVF

Administered 8 15�4 13 24�5 1�37 0�51 Not administered 44 84�6 40 75�5

1806 © 2013 John Wiley & Sons Ltd

_I. Arslan- €Ozkan et al.

Intention-to-Treat Analysis

Because of dropout, we employed an intention-to-treat

(ITT) analysis (Hollis & Campbell 1999, Polit & Gillespie

2010). The Last Observation Carried Forward method was

used (€Ust€un & G€un€us�en-Partlak 2009) where data were missing.

Reliability and validity

The IDS scale had a reliability coefficient of 0�90. The psy- chometric properties (Cronbach’s alpha 0�78–0�94) of the ISE-SF were similar to those of the original (Cousineau

et al. 2006), the Turkish (Arslan-Ozkan et al. 2013) and

the Portuguese (Galhardo et al. 2013) versions. The FAS

had a reliability coefficient of 0�88 in the original study (Glover et al. 1999), 0�80 in the Portuguese study (Lopes & Leal 2010) and 0�79 in the Turkish study (Okumus� &

Arslan-Ozkan 2012). Moreover, the FAS has been

employed in a variety of studies in Australia (Mahajan

et al. 2009), the UK (Salter-Ling et al. 2001) and Kuwait

(Omu & Omu 2010).

Results

After randomization, we compared groups on age, educa-

tion status, occupation, and duration of marriage, infertility

and infertility treatment to confirm homogeneity. The

Kolmogorov–Smirnov test confirmed that the data were not

normally distributed; therefore, we examined differences

using chi-squared tests. We then determined that women in

the intervention and control groups were statistically similar

(P > 0�05) and homogenous (Table 3).

Participant attrition

We required 120 infertile women for the study; however,

only 105 yielded data for analysis. The attrition rate was

12�5% (i.e. 15 out of 120). There was no significant differ- ence between the intervention (13�3%) and control groups (11�6%) in terms of attrition.

Findings on infertility distress

The intervention group showed a significant decrease

(t = 8�1, P < 0�001) in IDS scores between the pre-test (mean = 39�7, SD 11�2) and posttest (mean = 30�2, SD 7�5). In the control group, differences between mean IDS pre-

test (mean = 40�5, SD 10�6) and posttest (mean = 41�3, SD 11�1) scores were not significant (t = �1�5, P = 0�31). IDS scores were similar between the two groups prior to the

intervention (t = �0�38, P = 0�70), but significantly dif- fered after the intervention (t = �6�42, P < 0�001) (Table 4).

Table 3 (Continued).

Variable

Intervention

group

Control

group

v2 Pn (52) % n (53) %

Current ART

IUI 22 42�3 29 54�7 1�62 0�20 IVF 30 57�7 24 45�3

Cause of infertility

Female factor 19 36�5 23 43�4 2�62 0�93 Male factor 13 25�0 11 20�8 Both 13 25�0 8 15�0 Unexplained 7 13�5 11 20�8

*1000 Turkish Liras = US$ 502.

Statistically significant P < 0�05, as determined by chi-square analysis. ART, Assisting Reproductive Techniques; COH, Controlled Ovar-

ian Hyperstimulation; IUI, Intrauterine Insemination; IVF, In vitro

fertilization.

Table 4 Pre-test and posttest infertility distress, self-efficacy and adjustment scores in intervention and control groups.

Scales

Groups

Intervention group (n: 60) Control group (n: 60) Pre-test Posttest

Pre-test

Mean (SD)

Posttest

Mean (SD)

Pre-test

Mean (SD)

Posttest

Mean (SD) t P t P

IDS 39�7 (1�2) 30�2 (7�5) 40�5 (10�6) 41�3 (11�1) �0�38 0�70 �6�42 <0�000 t and P t = 8�11, P < 0�000 t = �1�5, P = 0�31 TISE-SF 22�6 (5�1) 28�0 (3�6) 21�9 (5�0) 21�9 (5�4) 0�77 0�44 7�33 <0�000 t and P t = �8�92, P < 0�000 t = �0�14, P = 0�89 T-FAS 25�4 (6. 8) 19�1 (6�1) 24�6 (7�3) 24�1 (7�0) 0�61 0�54 �4�20 <0�000 t and P t = 9�70, P < 0�000 t = 1�01, P = 0�32

© 2013 John Wiley & Sons Ltd 1807

JAN: ORIGINAL RESEARCH Watson’s Theory of Human Caring at infertile women’s care: a RCT

Findings on perceived infertility self-efficacy

The intervention group exhibited a statistically significant

difference (t = �8�9, P < 0�001) in the mean TISE-SF scores between pre-test (mean = 22�6, SD 5�1) and posttest (mean = 28, SD 3�6). In the control group, the difference between mean TISE-SF pre-test (mean = 21�9, SD 5�0) and posttest scores (mean = 21�9, SD 5�4) was not found to be significant (t = �0�14, P = 0�89). There was no difference between groups in terms of mean TISE-SF scores prior to

the intervention (t = 0�77, P = 0�44), but a significant dif- ference emerged following the intervention (t = 7�33, P < 0�001) (Table 4).

Findings on adjustment levels

Mean T-FAS scores in the intervention group decreased

from pre-test (mean = 25�4, SD 6�8) to posttest (mean = 19�1, SD 6�1) (t = 9�7, P < 0�001). In the control group, the difference between mean T-FAS pre-test

(mean = 24�6, SD 7�3) and posttest (mean = 24�1, SD 7�0) scores was not statistically significant (t = 1�0, P = 0�32). A between-groups comparison showed that T-FAS scores sig-

nificantly differed postintervention (t = �4�20, P < 0�001), but not pre-intervention (t = 0�61, P = 0�54; Table 4).

Discussion

Infertility distress

The inability to have children is stressful and distressing

(Daniluk 2001, Dyer et al. 2002, 2005, Allan 2007,

Cousineau & Domar 2007). Research in the Netherlands

found that Turkish women faced more intense emotional dif-

ficulties related to infertility than their Dutch counterparts

(Van Rooıj et al. 2007). These results are supported by Turk-

ish researchers (G€ulseren et al. 2006, Karlıdere et al. 2008,

Kazandı et al. 2011). Infertility in Turkish women is an

important negative social phenomenon ( €Ozkan & Baysal

2006). In the present study, we attempted to meet women’s

psychosocial needs using the Theory of Human Caring

framework. Weakening of humanistic values with the pro-

gress in technology has led to the birth of a new paradigm in

health care. This paradigm, based on the mind-body-soul

approach and also adopted by Watson is a caring–

healing approach. Psychological interventions based on this

approach facilitate effective coping with negative feelings

and reduce infertility-related distress in women with infertil-

ity (Lee 2003, Lemmens et al. 2004, Chan et al. 2006, Vali-

ani et al. 2010).

Perceived self-efficacy

We found that the intervention group exhibited a significant

increase in perceived self-efficacy, which confirms our sec-

ond hypothesis. Specifically, perceived infertility self-efficacy

was higher in women receiving Watson’s Theory of Human

Caring-based nursing care than in women who did not

receive such care. While perceived self-efficacy was the

same in both groups prior to the study, a significant differ-

ence was found between them following the intervention.

Coping behaviours include maintaining a positive atti-

tude, being relaxed while waiting for test results and deal-

ing with psychological changes related to treatment.

Individuals’ confidence in their own efficacy and skills in

coping and managing their infertility treatment should

result in more positive results (Cousineau et al. 2006).

To our knowledge, no researchers have reported the

results of an intervention intended to increase infertile

women’s self-efficacy based on the Theory of Human Car-

ing. However, some researcher have used methods recom-

mended in this theory to promote caring and healing, for

example, demonstrating that acupuncture increased self-

efficacy perception in infertile women (Kov�arov�a et al.

2010, Smith et al. 2011). Other researcher have offered an

online psychological intervention; this intervention was

found to increase perceived self-efficacy in women with

infertility (Cousineau et al. 2008).

Adjustment levels

We found that Theory of Human Caring-based nursing care

increased adjustment to infertility, supporting the hypothe-

sis that infertility adjustment levels are higher in the inter-

vention group than in the control group. Feelings of

hopelessness, loss, isolation and stigmatization, and anxiety

about the future and an inability to make plans, indicate an

inability to adjust to infertility (Mahajan et al. 2009). The

intervention made it possible for the women to share, com-

municate and accept their emotions; be creative; and engage

in independent problem-solving. Infertility-related adjust-

ment did not significantly differ between the intervention

and control groups prior to the study, but significantly dif-

fered following the Theory of Human Caring-based inter-

vention. Previous studies were found that coping strategies

that are problem-focused and pertain to finding positive

meanings are more effective in promoting adjustment

(Schmidt et al. 2005, Lee et al. 2010). In the present study,

interventions directed towards the expression and accep-

tance of emotions and feelings, and problem-solving, were

used.

1808 © 2013 John Wiley & Sons Ltd

_I. Arslan- €Ozkan et al.

Infertile women are confronted with many difficulties

during the treatment process, which require significant psy-

chological adjustments to be made jointly by both partners

(Boivin & Schmidt 2005, Kennedy 2008). In the present

study, women disclosed their treatment and life expecta-

tions, fears regarding treatment and all other relevant

thoughts. Women expressing their emotions and opinions

generally reported that they were relaxed and relieved; the

adverse effects of infertility may be mitigated through this

manner of intervention.

Limitations

We collection only quantitative data from the women; we

did not evaluate their subjective experiences. Moreover, evi-

dence-based recommendations on infertility are in favour of

evaluating couples (Kamel 2010); because compliance of

men with the treatment was inadequate, husbands were not

included in our study design. This study was carried out in

a university’s infertility centre. Private clinics were not

included in the study. Additionally, this study included only

Turkish women who have a mostly pronatalist perspective

(Ya�gmur & Oltuluo�glu 2012), which may have affected the

findings. We also note that the control group received only

routine nursing care – no comparison was made with a dif-

ferent care method or model, allowing for the possibility

that the placebo effect was responsible for improvements in

the treatment group.

The procedure of masking is used in many quantitative

studies to prevent bias stemming from human awareness.

Masking involves concealing information from participants,

data collectors, care providers or data analysts (Polit &

Beck 2013). A key limitation of this study is that due to the

nature of the research, it was not possible to blind the par-

ticipants to group assignment. Additionally, due to the

study being conducted for a doctoral thesis, the interview

and intervention were carried out by the same investigator

who was not therefore blinded to group assignment.

Conclusion

The present study was the first instance of Watson’s Theory

of Human Caring being used in the provision of nursing

care to women with infertility, in a randomized controlled

trial. The results demonstrated that the nursing care based

on Theory of Human Caring exerted positive effects on dis-

tress, perceived infertility self-efficacy and adjustment to

infertility in women. Although the results of this study are

promising, we recommend further testing of the model of

care to generalize the results beyond that of our sample.

Acknowledgements

The researchers thank the nurses at the infertility unit cen-

tre for their assistance with the research, and to the women

who agreed to participate in the study for the advancement

of nursing science. The researchers gratefully acknowledge

Prof Dr Jean WATSON for her continuous support

throughout this study. The researchers also thank Prof

Dr Mehmet Ziya Fırat for his excellent assistance with the

statistical evaluation of the data.

Funding

This study was funded by University of Akdeniz, Scientific

Research Project Unit.

Conflict of interest

No conflict of interest has been declared by the authors.

Author contributions

All authors meet at least one of the following criteria

(recommended by the ICMJE: http://www.icmje.org/

ethical_1author.html) and have agreed on the final version:

• substantial contributions to conception and design, acquisition of data, or analysis and interpretation of

data;

• drafting the article or revising it critically for important intellectual content.

References

Aky€uz A., G€urhan N. & Bakır B. (2008) Development and

validation of an infertility distress scale for Turkish women. TAF

Preventive Medicine Bulletin 7, 469–476.

Aliyeh G. & Laya F. (2007) Quality of life and its correlates

among a group of infertile Iranian women. Medical Science

Monitor 13, 313–317.

Allan H. (2007) Experiences of infertility: liminality and the role of

the fertility clinic. Nursing Inquiry 14, 132–139.

Arslan-Ozkan I., Okumus H., Lash A.A. & Fırat M.Z. (2013)

Cultural validation of the Turkish Version of the Infertility Self-

Efficacy Scale-Short Form (TISE-SF). Journal of Transcultural

Nursing. doi: 10.1177/1043659613508784.

Bandura A. (1998) Health promotion from perspective of social

cognitive theory. Psychology & Health 13, 623–649.

Beji N.K. (2001) Do�gurganlık ile ilgili sorunlar ve hems�irenin de�gis�en rol€u [Fertility-related issues and the changing role of the nurse]. In _Infertilite Sorunu, Yardımcı €Ureme Teknikleri ve

Hems�irelik Yaklas�ımı [Problem Infertility, Assisted Reproductive Technologies and Nursing Approach] (Beji N.K., ed.), Emek

Matbaacılık, _Istanbul, pp. 1–8.

© 2013 John Wiley & Sons Ltd 1809

JAN: ORIGINAL RESEARCH Watson’s Theory of Human Caring at infertile women’s care: a RCT

Boivin J. (2003) A review of psychosocial interventions in

infertility. Social Science & Medicine 57, 2325–2341.

Boivin J. & Schmidt L. (2005) Infertility-related stress in men and

women predicts treatment outcome 1 year later. Fertility and

Sterility 83, 1745–1752.

Boivin J., Griffiths E. & Venetis C.A. (2011) Emotional distress in

infertile women and failure of assisted reproductive technologies:

meta-analysis of prospective psychosocial studies. British Medical

Journal 342, d223.

Carson E.M. (2004) Do performance appraisals of registered nurses

reflect a relationship between hospital size and caring? Nursing

Forum 39, 5–13.

Chan C.H., Ng E.H., Chan C.L., HO & Chan T.H. (2006)

Effectiveness of psychosocial group intervention for reducing

anxiety in women undergoing in vitro fertilization: a randomized

controlled study. Fertility and Sterility 85, 339–346.

Childs A. (2006) The complex gastrointestinal patient and Jean

Watson’s Theory of Caring in nutrition support.

Gastroenterology Nursing 29, 283–288.

Cousineau T. & Domar A. (2007) Psychological impact of

infertility. Best Practice & Research Clinical Obstetrics &

Gynaecology 21, 293–308.

Cousineau T.M., Green T.C., Corsini E.A., Barnard T., Seibring

A.R. & Domar A.D. (2006) Development and validation of the

infertility self-efficacy scale. Fertility and Sterility 85,

1684–1696.

Cousineau T.M., Green T.C., Corsini E., Seibring A., Showstack

M.T., Applegarth L., Davidson M. & Perloe M. (2008) Online

psychoeducational support for infertile women: a randomized

controlled trial. Human Reproduction 23, 554–566.

Cox S.J., Glazebrook C., Sheard C., Ndukwe G. & Oates M.

(2006) Maternal self-esteem after successful treatment for

infertility. Fertility and Sterility 85, 84–89.

Daniluk J.C. (2001) Recontructing their lives: a longitudinal,

qualitative analysis of the transition to biological childlessness

for infertile couples. Journal of Counseling & Development 79,

439–449.

Deborah D., Dale R. & Laurie C. (2001) Promoting health among

infertile couples through support groups. Guidance &

Counseling 16, 110–115.

Devine K.S. (2003) Caring for the infertile woman. The American

Journal of Maternal/Child Nursing 28, 100–105.

Domar A., Clapp D., Slawsby E., Kessel B., Orav J. & Freizinger

M. (2000) The impact of group psychological interventions on

distress in infertile women. Health Psychology 19, 568–575.

Drenkard K.N. (2008) Integrating human caring science into a

professional nursing practice model. Critical Care Nursing

Clinics of North America 20, 403–414.

Dyer S.J., Abrahams N., Hoffman M. & van der Spuy Z.M.

(2002) Men leave me as I cannot have children’ women’s

experiences with involuntary childlessness. Human Reproduction

17, 1663–1668.

Dyer S.J., Abrahams N., Mokoena N.E., Lombard C.J. & van der

Spuy Z.M. (2005) Psychological distress among women suffering

from couple infertility in South Africa: a quantitative assessment.

Human Reproduction 20, 1938–1943.

Emery M., B�eran M.D., Darwiche J., Oppizzi L., Joris V., Capel

R., Guex P. & Germond M. (2003) Results from a prospective,

randomized, controlled study evaluating the acceptability and

effects of routine pre-IVF counselling. Human Reproduction 18,

2647–2653.

Fawcett J. (2005) Watson’s theory of human care. In

Contemporary Nursing Knowledge and Analysis and Evaluation

of Nursing Models and Theories, 2nd edn (Fawcett J., ed.),

Davis Company, Philadelphia, PA, pp. 51–59, 553–599.

Galhardo A., Cunha M. & Pinto-Gouveia J. (2013) Measuring self-

efficacy to deal with infertility: psychometric properties and

confirmatory factor analysis of the Portuguese version of the

Infertility Self-Efficacy Scale. Research in Nursing & Health 36,

65–74.

Gigliotti E. (2008) The value of nursing models in practice. Dokuz

Eyl€ul €Universitesi Hems�irelik Y€uksekokulu Elektronik Dergisi [Dokuz Eylul University School of Nursing Electronic Journal]

1, 42–50.

Glover L., Hunter M., Richards J.M., Katz M. & Abel P.D. (1999)

Development of fertility adjustment scale. Fertility and Sterility

72, 623–628.

G€ulseren L., C�etinay P., Tokatlioglu B., Sarikaya O.O., Gulseren S. & Kurt S. (2006) Depression and anxiety levels in infertile Turkish

women. The Journal of Reproductive Medicine 51, 421–426.

Hammond K.R. (2001) How to help an infertile couple. The Nurse

Practitioner 26(Suppl 1), 2–13.

Hollis S. & Campbell F. (1999) What is meant by intention to

treat analysis? Survey of published randomised controlled trials.

British Medical Journal 319, 670–674.

Hosaka T., Matsubayashi H., Sugiyama Y., Izumi S. & Makino T.

(2002) Effect of psychiatric group intervention on natural-killer

cell activity and pregnancy rate. General Hospital Psychiatry 24,

353–356.

Kamel R.M. (2010) Management of the infertile couple: an evidence-

based protocol. Reproductive Biology and Endocrinology 8, 21.

Karaniso�glu H. & Yazıcı S. (2009) Yardımcı €ureme teknikleri ve

hems�irelik yaklas�ımları [Assisted reproductive techniques and nursing approaches]. In _Infertilite Hems�ireli�gi [Infertility Nursing] (Beji K.N., ed.), Acar Basımve Cilt San Tic AS�, _Istanbul, pp. 69–88.

Karlıdere T., Bozkurt A., Ozmenler K.N., Ozsahin A., Kucuk T. &

Yetkin S. (2008) The Influence of emotional distress on the

outcome of in-vitro fertilization (IVF) and/or intracytoplasmic

sperm injection (ICSI) treatment among infertile Turkish women.

Israel Journal of Psychiatry & Related Sciences 45, 55–64.

Kavlak O. & Saruhan A. (2002) _Infertil kadınlarda yalnızlık d€uzeyi

ve bunu etkileyen fakt€orlerin incelenmesi [Study on determination

the loneliness level in infertile women and to assess the factors that

effect the loneliness level]. Ege Tıp Dergisi [Ege Journal of

Medicine] 41, 229–232.

Kazandı M., Gunday O., Mermer T.K., Erturk N. & Ozkınay E.

(2011) The status of depression and anxiety in infertile Turkish

couples. The Iranian Journal of Reproductive Medicine 9,

99–104.

Kennedy R. (2008) €Ureme endokrinolojisi/infertilite ve hems�ire [The nurse and REI]. (Okumus� H & Durgun-Ozan Y trans.). In _Infertilite ve Yardımla €Ureme Teknikleri [Infertility and Assisted

Reproduction] (Rızk B., Garcia-Velasco J., Sallam H. &

Makrigiannakis A., eds), (G€urgan T trans ed.), G€unes� Tıp Kitabevi, Ankara, pp. 562–569.

1810 © 2013 John Wiley & Sons Ltd

_I. Arslan- €Ozkan et al.

de Klerk C., Hunfeld J.A.M., Duivenvoorden H.J., den Outer M.A.,

Fauser B.C., Passchier J. & Macklon N.S. (2005) Effectiveness of a

psychosocial counselling intervention for first-time IVF couples: a

randomized controlled trial.Human Reproduction 20, 1333–1338.

Kov�arov�a P., Smith C.A. & Turnbull D.A. (2010) An exploratory

study of the effect of acupuncture on self-efficacy for women

seeking fertility support. Explore (NY) 6, 330–334.

Lee S.H. (2003) Effects of using a nursing crisis intervention

program on psychosocial responses and coping strategies of

infertile women during in vitro fertilization. Journal of Nursing

Research 11, 197–208.

Lee S.H., Wang S.C., Kuo C.P., Kuo P.C., Lee M.S. & Lee M.C.

(2010) Grief responses and coping strategies among infertile

women after failed in vitro fertilization treatment. Scandinavian

Journal of Caring Sciences 24, 507–513.

Lemmens G.M.D., Vervaeke M., Enzlin P., Bakelants E.,

Vanderschueren D., D’Hooghe T. & Demyttenaere K. (2004)

Coping with infertility: a body-mind group intervention programme

for infertile couples.Human Reproduction 19, 1917–1923.

Lopes V. & Leal I.P. (2010) Escala de ajustamento �a fertilidade

(EAF). Avaliac�~ao em sexualidade e parentalidade. LivPsic, Porto, pp. 114–127.

Mahajan N.N., Turnbull D.A., Davies M.J., Jindal U.N., Briggs

N.E. & Taplin J.E. (2009) Adjustment to infertility: the role of

intrapersonal and interpersonal resources/vulnerabilities. Human

Reproduction 24, 906–912.

Noorbala A.A., Ramazanzadeh F., Malekafzali H., Abedinia N.,

Forooshani A.R., Shariat M. & Jafarabadi M. (2008) Effects of a

psychological intervention on depression in infertile couples. The

International Journal of Gynecology & Obstetrics 101, 248–52.

Okumus� H. & Arslan-Ozkan _I. (2012) The Levels of Infertility Adjustment to the Turkish Women: A Descriptive Study. The

World Congress on Building Consensus in Gynecology, Infertility

and Perinatology (BCGIP): Controversies in Obstetrics,

Gynecology and Infertility (COGI), Barcelona. 76 pp.

Omu F.E. & Omu A.E. (2010) Emotional reaction to diagnosis of

infertility in Kuwait and successful clients’ perception of nurses’

role during treatment. BMC Nursing 9. Retrieved from http://

www.biomedcentral.com/1472-6955/9/5 on 4 October 2013. €Ozkan M. & Baysal B. (2006) Emotional distress of infertile

women in Turkey. Clinical & Experimental Obstetrics &

Gynecology 33, 44–46.

Payne D. & Goedeke S. (2007) Holding together: caring for clients

undergoing assisted reproductive technologies. Journal of

Advanced Nursing 60, 645–653.

Polit D.F. & Beck C.T. (2013) Essentials of Nursing Research:

Appraising Evidence for Nursing Practice. 8th edn, Lippincott

Williams & Wilkins, Philadelphia.

Polit D.F. & Gillespie B.M. (2010) Intention-to-treat in

randomized controlled trials: Recommendations for a total trial

strategy. Research in Nursing & Health 33, 355–368.

Salter-Ling N., Hunter M. & Glover L. (2001) Donor insemination:

exploring the experience of treatment and intention to tell. Journal

of Reproductive and Infant Psychology 19, 175–186.

SAS Institute (2001) SAS Software for Release 8.2. SAS Institute,

Cary, NC.

Schmidt L., Holstein B.E., Christensen U. & Boivin J. (2005)

Communication and coping as predictors of fertility problem

stress: cohort study of 816 participants who did not achieve a

delivery after 12 months of fertility treatment. Human

Reproduction 20, 3248–3256.

Schulz K.F., Altman D.G. & Moher D. (2010) CONSORT 2010

Statement: updated guidelines for reporting parallel group

randomized trials. British Medical Journal 340, 332.

Smith C.A., Ussher J.M., Perz J., Carmady B. & de Lacey S.

(2011) The effect of acupuncture on psychosocial outcomes for

women experiencing infertility: a pilot randomized controlled

trial. Journal of Alternative and Complementary Medicine 17,

923–930.

Sousa D.V., Zauszniewski A.J., Musil C.M., Price P.J.L. & Davis

S.A. (2005) Relationships among self-care agency, self-efficacy,

self-care and glycemic control. Research and Theory for Nursing

Practice: An International Journal 19, 217–230.

T€uzer V., Tuncel A., G€oka S., Do�gan-Bulut S., Y€uksel F.V., Atan

A. & G€oka E. (2010) Marital adjustment and emotional

symptoms in infertile couples: gender differences. Turkish

Journal of Medical Sciences 40, 229–237. €Ust€un B. & G€un€us�en-Partlak N. (2009) Randomize kontroll€u c�alısmalarda €orneklemden kayıplar oldu�gunda gerekli bir istatistiksel analiz: Intention to Treat Analizi [Intention to Treat

Analysis: a statistical analysis necessary when sample loss occur

in randomized-controlled trials]. Dokuz Eyl€ul €Universitesi

Hems�irelik Y€uksekokulu Elektronik Dergisi 1, 46–56. Valiani M., Abediyan S., Ahmadi S.M., Pahlavanzadeh S. &

Hassanzadeh A. (2010) The effect of relaxation techniques to

ease the stress in infertile women. Iranian Journal of Nursing

and Midwifery Research 215, 259–264.

Valsangkar S., Bodhare T., Bele S. & Sai S. (2011) An evaluation

of the effect of infertility on marital, sexual satisfaction indices

and health-related quality of life in women. Journal of Human

Reproductive Science 4, 80–85.

Van Rooıj F.B., Van Balen F. & Hermanns J.M.A. (2007)

Emotional distress and infertility: Turkish migrant couples

compared to Dutch couples and couples in Western Turkey.

Journal of Psychosomatic Obstetrics and Gynecology 28,

87–95.

Venkatesan L. (2005) Self-concept in infertile women. Nursing

Journal of India 96, 55–56.

Verhaak C.M., Smeenk J.M.J., van Minnen A., Kremer J.A.M. &

Kraaimaat F.W. (2005) A longitudinal, prospective study on

emotional adjustment before, during and after consecutive

fertility treatment cycles. Human Reproduction 20, 2253–2260.

Watson J. (2008) Nursing: Human Science and Human Care. Jones

& Bartlett Learning, New York.

Watson J. (2012) Human Caring Science: A Theory of Nursing,

2nd edn. Jones & Bartlett Learning, Sudbury, MA.

Wischmann T. (2008) Implications of psychosocial support in

infertility - a critical appraisal. Journal of Psychosomatic

Obstetrics & Gynecology 29, 83–90.

Ya�gmur Y. & Oltuluo�glu H. (2012) Social support and

hopelessness in women undergoing infertility treatment in eastern

Turkey. Public Health Nursing 29, 99–104.

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