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Effectiveness of reflexology on anxiety of patients undergoing cardiovascular interventional procedures: A systematic review and meta‐analysis of randomized controlled trials

Ramesh Chandrababu1 | Eilean Lazarus Rathinasamy2 | C. Suresh3 | Jyothi Ramesh4

1Manipal College of Nursing, Manipal

Academy of Higher Education, Manipal,

Karnataka, India

2Department of Adult Health and Critical

Care, College of Nursing, Sultan Qaboos

University, Muscat, Oman

3Department of Physical and Health

Sciences, SRM Institute of Science and

Technology, Chennai, TN, India

4Udupi College of Nursing, Sri Krishna

Educational Trust, Manipal, Karnataka, India

Correspondence

Dr. Ramesh Chandrababu, Manipal College

of Nursing, Manipal Academy of Higher

Education, Manipal, Karnataka, India.

Email: [email protected]

Abstract

Aim: To appraise the evidence concerning the effect of reflexology on the anxiety

in patients undergoing cardiovascular interventional procedures.

Background: Anxiety, fear, and other unpleasant emotional experiences are com-

mon among patients before and after cardiovascular interventional procedures. The

higher anxiety may affect prognosis and recovery of patients.

Design: A systematic review and meta‐analysis. Data sources: The MEDLINE, CINAHL (Cumulative Index to Nursing and Allied

Health Literature), Cochrane Central Register of Controlled Trials (Cochrane Library),

EMBASE, PsycINFO, and Web of Science were searched between 2001–2017. Review methods: Randomized controlled trials evaluated the effectiveness of

reflexology on anxiety among patients undergoing cardiovascular interventional pro-

cedures were included. Meta‐analysis was done using Revman 5.3. Results: Ten trials, representing 760 patients with the mean age of 59, fulfilled the

inclusion criteria. Reflexology significantly decreased the anxiety of patients under-

going cardiovascular interventional procedures in the treatment group compared

with the control group.

Conclusion: Reflexology has some positive effects on anxiety among patients

undergoing cardiovascular procedures. It may be a useful complementary therapy

and further research is necessary to create reliable evidence.

K E Y W O R D S

anxiety, cardiac surgical procedures, complementary therapies, coronary angiography, meta-

analysis, nursing, percutaneous coronary intervention, reflexology, systematic reviews

1 | INTRODUCTION

Cardiovascular diseases (CVDs) have become the leading health

problems in the developing and the developed countries. CVD is the

most common cause of morbidity and mortality worldwide. Coronary

artery disease (CAD) is the most common among all cardiovascular

disease conditions (Sharif, Shoul, Janati, Kojuri, & Zare, 2012).

Patients with CAD, who do not respond to routine medical treat-

ment, will have to undergo cardiovascular procedures that include

coronary angiography, percutaneous transluminal coronary angio-

plasty (PTCA), percutaneous coronary intervention (PCI), and coro-

nary artery bypass graft (CABG) surgery (Hillis et al., 2011).

Patients with the higher anxiety before coronary angiography

and PCI may have unfavourable physical and psychological experi-

ences (Gallagher, Trotter, & Donoghue, 2010). Fear, anxiety, and

other unpleasant emotional experiences are common before coro-

nary angiography and other cardiovascular interventions. Surprisingly,

anxiety level before coronary angiography was reported to be higher

Received: 28 December 2017 | Revised: 24 June 2018 | Accepted: 27 June 2018 DOI: 10.1111/jan.13822

J Adv Nurs. 2019;75:43–53. wileyonlinelibrary.com/journal/jan © 2018 John Wiley & Sons Ltd | 43

than before the cardiac surgery (Moradi & Adib‐Hajbaghery, 2015). Patients undergoing coronary angiography experience higher anxiety

and depression that may affect their prognosis and recovery (Delewi

et al., 2017; Korkmaz, Korkmaz, Yildiz, Gündoğan, & Atmaca, 2017).

There is a significant association found between anxiety and slow

coronary blood flow (Durmaz et al., 2014; Yalvac et al., 2017).

The anxiety during pre and postoperative period positively corre-

lated with a higher risk of atrial fibrillation, length of hospital stay,

and readmission after cardiac surgery (Albert et al., 2009; Tully,

Baker, Turnbull, & Winefield, 2008). The higher level of anxiety

experienced by patients awaiting cardiac surgical procedures, which

can negatively affect their existing disease condition and surgical

intervention may lead to longer recovery (Guo, 2015). Anxiety, pain,

stress, and sleep problems are usual after a surgical procedure. All

these factors may disturb treatment process and quality of life of

patients undergoing surgery (Mitchinson et al., 2007). Postopera-

tively, a better quality of life among patients undergoing cardiac sur-

gery associated with lower anxiety level (Tung, Hunter, Wei, & Wei,

2008).

1.1 | Background

An emphasis has been made on the nonpharmacological interven-

tions and complementary therapies to decrease or eliminate the anx-

iety in recent years. These therapies comprise a wide range of

methods that are noninvasive, relatively simple, and cost‐effective and with lesser or no side effects compared with drugs (Lu, Chen, &

Kuo, 2011). Reflexology is a systematic practice where applying

some pressure on any particular points on feet and hands gives

impacts on the health of the related parts of the body (Wang, Tsai,

Lee, Chang, & Yang, 2008).

When a reflex point or zone is stimulated, the body cells react

by generating a reflex effect on the corresponding nerves, tissues

muscles, and organs. Reflexology effects are well‐known to liberate the symptoms of stress by increasing blood flow, decreasing tension,

calming the mental state, accelerating immunity, and promoting a

sense of well‐being (Embong, Soh, Ming, & Wong, 2017). Reflexol- ogy improves the blood and energy circulation, gives a sense of

relaxation and maintains homoeostasis. Endorphin is a body's natural

pain‐relieving chemical released as a response to reflexology (Embong, Soh, Ming, & Wong, 2015).

Decreasing anxiety has higher clinical importance and is one of

the essential goals of comprehensive nursing care. Various tech-

niques, commonly invasive and pharmacological interventions are

used to reduce the anxiety of patients. Anxiety stimulates the sym-

pathetic nervous system activities through biochemical and physio-

logical responses and results in the release of epinephrine and

norepinephrine. As a consequence, heart rate, respiration rate, blood

pressure, and demand for myocardial oxygen are increased. The

increased workload of the heart also increases the risk of dysrhyth-

mia and ischaemia (Adib Hajbaghery, Moradi, & Mohseni, 2014).

Nurses are in the vital position to assess patient's needs for

these complementary therapies, to analyse strength and quality of

evidence to implement evidence‐based interventions. Nurses who are caring patients undergoing cardiovascular interventional proce-

dures should aim at decreasing patients’ anxiety because anxiety can negatively affect patients’ experiences of intensive care, well‐being, and recovery. The effect of reflexology proven generally in all the

disease conditions, but still, it is not yet clearly understood in

patients undergoing cardiovascular procedures.

As per our knowledge, this is the first systematic review and

meta‐analysis on the effect of reflexology on patients undergoing

Why is this research or review needed?

• Patients undergoing cardiovascular intervention proce- dures who experience higher anxiety may have adverse

physical, psychological consequences and that may affect

their prognosis and recovery. There is a significant asso-

ciation between anxiety and slow coronary blood flow.

• An emphasis has been given to nonpharmacological interventions to eliminate or decrease anxiety in recent

years.

• Reflexology is one of the nonpharmacological interven- tions; the effect of reflexology proven in general health

conditions. However, the efficacy of reflexology on the

anxiety in patients undergoing cardiovascular procedures

remains unclear.

What are the key findings?

• Reflexology is significantly associated with decreasing anxiety of patients undergoing cardiovascular interven-

tional procedures.

• However, there is a low quality of evidence due to the unclear risk of bias, inconsistency, and imprecision in

some of the trials included in this meta-analysis.

• None of the reviewed trials reported any harmful effects of reflexology intervention.

How should the findings be used to influence

policy/practice/research/education?

• Reflexology may serve as a useful complementary ther- apy for decreasing anxiety of patients undergoing the

cardiovascular procedures.

• There is a need for rigorous research to prove the effi- cacy of reflexology and, the higher methodological quali-

ties of randomized controlled trials are necessary to

create a reliable and higher quality of evidence.

• Future research must also focus on scientific reasons behind reflexology interventions in the area of cardiac

interventional procedures measuring biomarkers such as

endorphins, as exact mechanisms are not yet understood

clearly.

44 | CHANDRABABU ET AL.

cardiovascular interventional procedures. As complementary thera-

pies are given higher importance globally, the findings of this review

will provide new insight on the effectiveness of reflexology on anxi-

ety to the scientific community. Therefore, this meta‐analysis on the effect of reflexology was decided to conduct and this article pro-

vides evidence of the randomized controlled trials describing clinical

effects of patients following cardiovascular interventional proce-

dures.

2 | THE REVIEW

2.1 | Aim

This systematic review and meta‐analysis aimed to appraise the evi- dence concerning the effectiveness of reflexology on the anxiety of

patients undergoing cardiovascular procedures.

2.2 | Design

This is a quantitative systematic review with meta‐analysis examining the effectiveness of reflexology on anxiety among patients undergo-

ing cardiovascular interventional procedures. The guidelines of

Cochrane Collaboration were adopted to carry out this systematic

reviews and meta‐analysis (Higgins & Green, 2011) and reported using Preferred Reporting Items for Systematic Reviews and Meta‐ Analyses (PRISMA) statement (Moher et al., 2015).

2.3 | Search methods

A comprehensive search strategy was developed using the search or

key terms connected to PICO (population or patient, intervention,

comparator or control, and outcomes) and two authors indepen-

dently searched MEDLINE, CINAHL (Cumulative Index to Nursing

and Allied Health Literature), CENTRAL (Cochrane Central Register

of Controlled Trials – The Cochrane Library), EMBASE, PsycINFO, and Web of Science between 2001–2017. We explored for random- ized controlled trials (RCTs) that used reflexology as an intervention

for patients following the cardiovascular procedures.

The following combinations of MeSH (Medical Subject Heading)

terms or keywords were used: reflexology, foot reflexology, zone

therapy, anxiety, coronary angiography, percutaneous coronary inter-

vention, cardiac surgery, CABG surgery, cardiac surgical procedures,

and randomized controlled trial. A manual search of references from

all relevant trials that fulfilled inclusion criteria as well as related sys-

tematic reviews, meta‐analyses, and review articles was also con- ducted. Duplicate records and trials were excluded by screening the

titles and abstracts. All the remaining original full‐text articles were screened to assess the inclusion criteria.

2.3.1 | Participants

The trials included adult (aged above 18 years) patients undergoing

the cardiovascular interventional procedure that includes coronary

angiography, percutaneous coronary intervention, coronary artery

bypass graft, and open heart surgery. The patients who had a ran-

dom allocation to either a treating group that received reflexology or

a control group that received the usual care.

2.3.2 | Interventions

Patients in the experimental group had to receive reflexology inter-

ventions. The trials evaluated the effect of reflexology or

reflexotherapy interventions among patients undergoing cardiovascu-

lar interventional procedures were included.

2.3.3 | Comparison

The control group who received regular or routine postoperative

care of the hospital.

2.3.4 | Outcomes

Anxiety was the primary outcome analysed in this systematic review

and meta‐analysis. We assessed biophysiological parameters that include pain, heart rate, respiration rate, systolic blood pressure,

diastolic blood pressure, oxygen saturation (SpO2), satisfaction, mean

arterial pressure, and quality of life (QOL) as secondary outcomes.

2.3.5 | Study design

Randomized controlled trials (RCTs) that were published in English

and included reflexology interventions for patients undergoing car-

diovascular interventional procedures.

2.4 | Search outcome

The search strategy identified 4,526 studies through electronic data-

bases. Fifty‐two duplicate records were excluded. After assessing the titles and abstracts, 4,454 studies were omitted, as they did not meet

the criteria of the review according to PICO. After assessing the full

text, another ten articles were excluded, as they did not match the

inclusion criteria of the systematic review and meta‐analysis. The rea- sons for excluding trials were non‐RCTs; the study did not include reflexology as an intervention and involved patients undergoing car-

diovascular procedures as mentioned in inclusion criteria. Although an

RCT evaluated the effect of reflexology on anxiety during minimally

invasive varicose vein surgery, we decided to exclude as the trial did

not meet inclusion criteria (Hudson, Davidson, & Whiteley, 2015).

Finally, ten trials were involved in qualitative and narrative synthesis.

Five trials were included in the meta‐analysis. The flow diagram of study selection process is presented in Figure 1.

2.5 | Quality appraisal

The Cochrane risk of bias tool was used to assess the risk of bias of

included trials (Higgins & Green, 2011). No trial demonstrated

CHANDRABABU ET AL. | 45

selection bias, as there were 100% low risk of bias and 60% of the

unclear risk of bias noted in the allocation concealment and perfor-

mance bias was about 25%. All the trials demonstrated 100% of low

risk in attrition bias (incomplete outcome data) and low risk of bias

in the selective reporting. The details regarding the percentages

across all included trials and judgements about each risk of bias item

are presented in Figure 2.

2.6 | Data extraction

Two authors independently extracted the data from trials included and

dissimilarity was resolved by discussing with a third reviewer. A data

extraction form, which included author, year of publication, country,

design, sample size, gender and mean age of patients, details of the inter-

vention, outcomes, instruments, reliability, and trial findings were used.

Records identified through database searching

(n = 4517)

S cr

e e n in

g In

cl u d e d

E lig

ib ili

ty Id

e n tif

ic a tio

n Additional records identified through other sources

(n = 9)

Records after duplicates removed (n = 4474)

Records screened (n = 4474)

Records excluded (n = 4454)

Full-text articles assessed for eligibility

(n = 20)

Full-text articles excluded, with reasons

(n =10) Non RCTs – 2

Did not include reflexology as study intervention – 6 Study did not involve

cardiovascular procedure - 2 Studies included in narrative synthesis

(n = 10)

Studies included in quantitative synthesis

(meta-analysis) (n = 5)

FIGURE 1 Flow diagram of study selection [Colour figure can be viewed at wileyonlinelibrary.com]

Random sequence generation (selection bias)

Allocation concealment (selection bias) Blinding participants and personnel

(performance bias) Blinding of outcome assessment (detection bias)

Incomplete outcome data (attrition bias)

Selective reporting (reporting bias)

Other bias

0%

Low risk of bias Unclear risk of bias High risk of bias

25% 50% 75% 100% FIGURE 2 Risk of bias graph [Colour figure can be viewed at wileyonlinelibrary.c om]

46 | CHANDRABABU ET AL.

T A B L E

1 S u m m ar y o f d at a fr o m

al l in cl u d e d R C T s

A u th o r, y e ar , d e si g n

lo ca ti o n

S am

p le

si ze /

g ro u p

G e n d e r

T y p e o f

p ro ce

d u re

A g e in

y e ar s

In te rv e n ti o n

O u tc o m e s

m e as u re s

In st ru m e n t

S tu d y fi n d in g s

L im

it M e an

T y p e o f re fl e x o lo g y

D u ra ti o n an

d fr e q u e n cy

N am

e r v al u e

B ab

aj an

i e t al ., 2 0 1 4 ;

R C T , Ir an

8 8 E G : 2 9

C G : 2 9

P la ce b o : 3 0

M al e : 8 8

F e m al e : 0 0

O p e n h e ar t

su rg e ry

4 0 –8

0 y e ar s

6 1

F o o t re fl e xo

lo g y

2 0 m in

an d

si n g le

se ss io n

P ai n

N R S

0 .9 4

A si g n if ic an

t d e cr e as e

in p ai n (p

< 0 .0 5 )a

B ag h e ri ‐N

e sa m i

e t al ., 2 0 1 4 ; R C T , Ir an

8 0 E G : 4 0

C G : 4 0

M al e : 4 0

F e m al e : 4 0

C A B G

A g e ab

o v e

1 8 y e ar s

5 8

F o o t re fl e xo

lo g y

2 0 m in

an d

fo u r se ss io n s

A n xi e ty

S A I

V A S

0 .9 6

A si g n if ic an

t re d u ct io n

in an

xi e ty

(p <

0 .0 5 )a

E b ad

i e t al ., 2 0 1 5 ; R C T ,

Ir an

8 8 E G : 3 4

C G : 3 2

P la ce b o : 3 0

M al e : 4 7

F e m al e : 4 5

O p e n h e ar t

su rg e ry

2 5 –7

5 y e ar s

5 9

F o o t re fl e xo

lo g y

2 0 m in

an d

si n g le

se ss io n

H R , R R , S B P ,

D B P , M A P ,

S p O 2 an

d

v e n ti la ti o n

w e an

in g ti m e

D te x

e le ct ro n ic

m o n it o r

— T h e re

w as

a si g n if ic an

t

sh o rt e r d u ra ti o n o f

w e an

in g ti m e in

th e

e xp

e ri m e n ta l g ro u p

(p <

0 .0 5 )a b u t n o

d if fe re n ce

in

p h y si o lo g ic al

p ar am

e te rs

(p >

0 .0 5 )a

G u n n ar sd o tt ir &

Jo n sd o tt ir , 2 0 0 7 ; R C T ,

Ic e la n d

9 E G : 5

C G : 4

M al e : 0 8

F e m al e : 0 1

C A B G

A g e ab

o v e

1 8 y e ar s

6 5

F o o t re fl e xo

lo g y

2 0 m in

an d

si n g le

se ss io n

A n xi e ty

S A I

0 .9 3

N o si g n if ic an

t d e cr e as e

in an

xi e ty

(p <

0 .0 5 )b

H e id ar i e t al .,

2 0 1 7 ; R C T ,

Ir an

9 0 E G : 4 5

C G : 4 5

M al e : 3 5

F e m al e : 1 5

C o ro n ar y

an g io g ra p h y

A g e ab

o v e

1 8 y e ar s

5 8

H an

d re fl e xo

lo g y

2 0 m in

an d

si n g le

se ss io n

A n xi e ty

S A I

0 .8 2

A si g n if ic an

t d e cr e as e

in an

xi e ty

sc o re s at

p = 0 .0 0 1

(i n d e p e n d e n t t te st )

K h al e d if ar

e t al ., 2 0 1 7 ;

R C T , Ir an

7 5 E G : 2 5

C G : 2 5

P la ce b o : 2 5

M al e : 3 8

F e m al e : 3 7

C o ro n ar y

an g io g ra p h y

A g e ab

o v e

1 8 y e ar s

6 6

F o o t re fl e xo

lo g y

3 0 m in

an d

si n g le

se ss io n

A n xi e ty , H R , R R ,

S B P , an

d D B P

S A I

0 .9 7

A si g n if ic an

t re d u ct io n

in an

xi e ty

sc o re s

(p <

0 .0 0 1 )a

M e i e t al ., 2 0 1 7 ;

R C T , C h in a.

1 0 0

E G : 5 0

C G : 5 0

M al e : 7 3

F e m al e : 2 7

C o ro n ar y

an g io g ra p h y

4 0 –7

9 y e ar s

6 3

H an

d re fl e xo

lo g y

1 5 m in

an d

th re e se ss io n s

A n xi e ty , H R , S B P ,

D B P an

d Q u al it y

o f L if e

H A M A

S F ‐3 6

0 .9 3

T h e re

w as

a si g n if ic an

t

d e cr e as e in

an xi e ty

(p <

0 .0 5 )b

b u t n o

d if fe re n ce

in H R , S B P ,

D B P , an

d S h o rt ‐f o rm

h e al th

su rv e y .

M o b in i‐B

id g o li

e t al ., 2 0 1 7 ;

R C T , Ir an

8 0 E G : 4 0

C G : 4 0

M al e : 4 5

F e m al e : 3 5

C o ro n ar y

an g io g ra p h y

N R

6 1

H an

d re fl e xo

lo g y

2 0 m in

an d

si n g le

se ss io n

A n xi e ty

S A I

0 .9 2

A si g n if ic an

t d if fe re n ce

in an

xi e ty

sc o re s

b e tw

e e n th e

e xp

e ri m e n ta l an

d

co n tr o l g ro u p

(p = 0 .0 0 3 )

(i n d e p e n d e n t t te st ).

(C o n ti n u es )

CHANDRABABU ET AL. | 47

2.7 | Synthesis

The primary outcome measure (anxiety) was compared between patients

who received reflexology intervention and the patients in the control

group who were in usual care in each study. The meta‐analysis was per- formed to pool results of RCTs. The effect sizes for reflexology interven-

tions were estimated for the continuous outcome with 95% confidence

intervals pooling mean difference and standardized mean difference.

The heterogeneity in the included trials was analysed using I2 value. We

carried out meta‐analysis for reflexology intervention and primary out- come as matched with the control group. The effects of reflexology

intervention were calculated using a random‐effects model to compute weighted mean differences and standardized mean differences with con-

fidence intervals of 95%. All the data were analysed and pooled using

the software RevMan v5.3. The GRADE approach and guidelines (Guyatt

et al., 2013) were adopted to provide quality and strength of the evi-

dence and outcome measures are presented in the “Summary of find- ings” (Table 2). The magnitude of effect was rated in the categories: small (effect size around 0.2), medium (effect size around 0.5), and large

(effect size of 0.8 or higher).

3 | RESULTS

3.1 | Patients characteristics

The reviewed trials involved 760 patients and the number of study

participants ranged from 09–100. The mean age of the complete study participants was 59 ranged from 48–66 in years. In most of the trials, both genders were included except two trials (Babajani,

Darzi, Ebadi, Mahmoudi, & Nasiri, 2014; Molavi Vardanjani et al.,

2013) that involved only male gender. Most of the participants in

the involved trials were male patients (N = 509, 66%). In all included

trials, patients followed elective cardiovascular intervention proce-

dures. The types included were coronary angiography, PCI, CABG,

and open heart surgery. In all studies, the intervention of reflexology

was implemented only in the treatment group and the usual or regu-

lar care provided to the control group. The summary data of the

reviewed trials are presented in Table 1.

3.2 | Effect of interventions

The primary outcome analysed in this meta‐analysis was anxiety. We calculated differences in the effect of reflexology between posttest

scores for both reflexology and control groups. The details of the

primary outcome, quality of evidence, and magnitude of effect are

presented in the Summary of Findings in Table 2. The details regard-

ing secondary outcomes are presented in Table 3.

3.2.1 | Effect of reflexology in coronary angiography

Five RCTs involving 419 patients revealed the effectiveness of reflexol-

ogy intervention in coronary angiography (Heidari, Rejeh, Heravi‐

T A B L E

1 (C o n ti n u e d )

A u th o r, y e ar , d e si g n

lo ca ti o n

S am

p le

si ze /

g ro u p

G e n d e r

T y p e o f

p ro ce

d u re

A g e in

y e ar s

In te rv e n ti o n

O u tc o m e s

m e as u re s

In st ru m e n t

S tu d y fi n d in g s

L im

it M e an

T y p e o f re fl e x o lo g y

D u ra ti o n an

d fr e q u e n cy

N am

e r v al u e

M o e in i e t al .,

2 0 1 1 ; R C T ,

Ir an

5 0 E G : 2 5

C G : 2 5

M al e : 3 5

F e m al e : 1 5

C A B G

A g e ab

o v e

1 8 y e ar s

5 7

F o o t re fl e xo

lo g y

3 0 m in

an d

si n g le

se ss io n

H R , R R , S B P ,

an d D B P

‐ ‐

T h e re

w as

a si g n if ic an

t

d e cr e as e in

S B P an

d

D B P in

th e tr e at m e n t

g ro u p (p

< 0 .0 5 )

(i n d e p e n d e n t an

d

p ai re d t te st ).

M o la v i V ar d an

ja n i e t al .,

2 0 1 3 ; R C T , Ir an

1 0 0

E G : 5 0

C G : 5 0

M al e : 1 0 0

F e m al e : 0 0

C o ro n ar y

an g io g ra p h y

N R

5 4

F o o t re fl e xo

lo g y

3 0 m in

an d

si n g le

se ss io n

A n xi e ty

S A I

0 .8 6

T h e re

w as

a si g n if ic an

t

re d u ct io n in

an xi e ty

sc o re s (p

= 0 .0 0 0 1 )b

R C T : ra n d o m iz e d co

n tr o lle d tr ia l; E G : E xp

e ri m e n ta l g ro u p ; C G : co

n tr o l g ro u p ; P G : p la ce b o g ro u p ; C A B G : C o ro n ar y ar te ry

b y p as s g ra ft ; S B P : S y st o lic

b lo o d p re ss u re ; D B P : D ia st o lic

b lo o d p re ss u re ; H R : H e ar t

ra te ; R R : R e sp ir at io n ra te ; M A P : M e an

ar te ri al

p re ss u re ; S p O 2 : O xy g e n sa tu ra ti o n ; N R S : N u m e ri ca l R at in g S ca le ; N R : N o t re p o rt e d ; S A I: S ta te

A n xi e ty

In v e n to ry ; H A M A : H am

ilt o n A n xi e ty

R at in g S ca le ; S F ‐

3 6 : S h o rt ‐F o rm

H e al th

S u rv e y ; S F ‐M

P Q : S h o rt ‐f o rm

M cG

ill P ai n Q u e st io n n ai re ; r: re lia b ili ty

v al u e o f d at a co

lle ct io n to o l.

a A n al y si s o f V ar ia n ce

(A N O V A ).

b M an

n –W

h it n e y U

te st .

48 | CHANDRABABU ET AL.

T A B L E

2 S u m m ar y o f fi n d in g s

R e fl e x o lo g y co

m p ar e d to

u su al

ca re

fo r p at ie n ts

u n d e rg o in g ca rd io v as cu

la r p ro ce

d u re s

P at ie n t o r p o p u la ti o n : P at ie n ts

u n d e rg o in g ca rd io v as cu

la r p ro ce

d u re s

S e tt in g : C ar d io v as cu

la r u n it s

In te rv e n ti o n : R e fl e x o lo g y

C o m p ar is o n : U su al

ca re

o r co

n tr o l g ro u p

O u tc o m e s

A n ti ci p at e d ab

so lu te

e ff e ct sa

(9 5 %

C I)

R e la ti v e e ff e ct

(9 5 %

C I)

N o . o f p ar ti ci p an

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CHANDRABABU ET AL. | 49

Karimooi, Tadrisi, & Vaismoradi, 2017; Khaledifar, Nasiri, Khaledifar,

Khaledifar, & Mokhtari, 2017; Mei, Miao, Chen, Huang, & Zheng, 2017;

Mobini‐Bidgoli, Taghadosi, Gilasi, & Farokhian, 2017; Molavi Vardanjani et al., 2013). A meta‐analysis with a model of random effects revealed that reflexology significantly decreased anxiety (SMD = −1.31 (large

effect size), confidence interval [CI] 95%: −2.48, −0.13) and statistically,

there was a significant difference between the reflexology and the con-

trol group (Z = 2.18, p = 0.03) (Figure 3). There is a low quality of evi-

dence due to the unclear risk of bias, considerable heterogeneity and

inconsistency because the I² statistic value is 96% (Table 2).

3.3 | Secondary outcomes

The secondary outcomes included in this study were heart rate, res-

piration rate, mean arterial pressure, pain, systolic and diastolic blood

pressure, oxygen saturation (SpO2), satisfaction, and Quality of life.

A narrative synthesis was carried out to assess the effectiveness of

reflexology on the secondary outcomes. Five trials assessed the

effect of reflexology on secondary outcomes.

Out of six trials, three showed a positive effect of the reflexology on

secondary outcomes (Babajani et al., 2014; Khaledifar et al., 2017;

Moeini, Kahangi, Valiani, & Heshmat, 2011) and two (trials) did not show

the positive effects (Ebadi, Kavei, Moradian, & Saeid, 2015; Mei et al.,

2017). A summary of secondary outcome data is shown in Table 3.

3.4 | Publication bias

As there were only a few trials involved in this meta‐analysis, the potential for publication bias is not assessed in this systematic

review and meta‐analysis.

3.5 | Psychometrics

The reliability of instruments used to evaluate outcome measures in

included trials was found to be reliable and adequate. The names of

instruments and reliability values of respective instruments are pre-

sented in Table 1.

3.6 | Quality of the evidence

Overall, there was low quality of evidence for the estimated primary

outcome due to the unclear risks of bias, inconsistency, and consid-

erable heterogeneity. There was no higher quality evidence on the

primary outcome (Table 2).

4 | DISCUSSION

There is evidence available that the reflexology intervention can lead

to positive health outcomes among patients in general health condi-

tions (Song et al., 2015) however, lesser is known about the effect

among patients following cardiovascular interventional procedures.

This research used a meta‐analysis of RCTs to explore the effective- ness of reflexology interventions for patients undergoing cardiovas-

cular procedures.

In this meta‐analysis, the primary objective was to evaluate whether reflexology interventions can decrease anxiety or not. A

comprehensive and systematic review of randomized controlled trials

published up to 2017 was performed to appraise the present evi-

dence about the effectiveness of reflexology intervention among

TABLE 3 Effect of reflexology intervention on secondary outcomes

Secondary outcomes HR RR SBP DBP MAP SpO2 Pain Satisfaction QOL

Babajani et al., 2014 = = = = = = ↓ = =

Ebadi et al., 2015 NS NS NS NS NS NS = = =

Khaledifar et al., 2017 ↓ ↓ ↓ ↓ = = = = =

Mei et al., 2017 NS NS NS NS = = = = NS

Moeini et al., 2011 NS NS ↓ ↓ = = = = =

RCT: randomized controlled trial; HR: heart rate; RR: respiration rate; QOL: Quality of Life; MAP: mean arterial pressure; SBP: systolic blood pressure;

DBP: diastolic blood pressure; SpO2: oxygen saturation; NS: No statistical significant difference in the reflexology and control group; ↓: Significant

decrease with the reflexology group; ↑: Significant increase with the reflexology group; =: Not included as a study outcome in the analysed trials.

Study or Subgroup Mean MeanSD Reflexology Control Std. Mean Difference

SDTotal Total Weight IV, Random, 95% CI Std. mean difference IV, Random, 95% CI

–4 –2 0 Favours [Reflexology] Favours [control]

2 4

Total (95% CI)

Heidari et al. (2017) Khaledifar et al. (2017) Mei et al. (2017) Mobini-Bidgoli et al. (2017) Vardanjani et al. (2013)

42.67 34.7 11.8 48.5

45.24

1.47 4.7 2.9

7.65 3.32

45 25 49 40 50

45 25 50 40 50

1.78 9.2 3.4

4.95 5.06

48.66 46.5

16 51.4 43.7

19.5% 19.6% 20.3% 20.2% 20.4%

–3.64 [–4.32, –2.96] –1.59 [–2.23, –0.95] –1.32 [–1.75, –0.88] –0.45 [–0.89, –0.00]

0.36 [–0.04, 0.75]

Heterogeneity: Tau2 = 1.73; Chi2 = 112.56, df = 4 (p < 0.00001); l2 = 96% Test for overall effect: Z = 2.18 (p = 0.03)

209 210 100.0% –1.31 [–2.48, –0.13]

FIGURE 3 Effect of reflexology on anxiety in coronary angiography [Colour figure can be viewed at wileyonlinelibrary.com]

50 | CHANDRABABU ET AL.

patients following cardiovascular interventional procedures. The trials

included in this meta‐analysis were from both the developing and the developed countries.

Ten trials were identified and analysed. Five RCTs were involved in

the meta‐analysis that produced positive results (Heidari et al., 2017; Khaledifar et al., 2017; Mei et al., 2017; Mobini‐Bidgoli et al., 2017; Molavi Vardanjani et al., 2013). The meta‐analysis showed that reflexol- ogy significantly decreased the anxiety of patients undergoing cardio-

vascular procedures. In the narrative synthesis, out of 10 trials, nine

(90.9%) concluded that the reflexology had positive results while one

(Gunnarsdottir & Jonsdottir, 2007) reported no positive results. None of

the reviewed trials reported any harmful effects of reflexology interven-

tion. The summary of all included trials, details of interventions, out-

come measures, and their results are presented in Table 1.

The findings of our systematic review and meta‐analysis are in agree- ment with previous systematic reviews, which concluded that reflexology

has positive benefits; however, reliable evidence in patients undergoing

the cardiovascular procedures remains unanswerable. Our study has

explored benefits of reflexology specifically for patients undergoing car-

diovascular interventional procedures compared with previous system-

atic reviews evaluated in general disease and health conditions (Ernst,

2009; Lee, Han, Chung, Kim, & Choi, 2011; Song et al., 2015).

This meta‐analysis shows that there is some evidence that the reflex- ology benefits patients positively following cardiovascular procedures.

This result provides preliminary support for healthcare professionals and

nurses to implement reflexology interventions for patients undergoing

cardiac interventional procedures. However, these results have to be

interpreted with caution considering the low quality of evidence in out-

come measure analysed (Table 2). There is a high demand for well‐ designed and higher quality randomized controlled trials to develop reli-

able evidence of reflexology interventions in improving positive out-

comes among patients undergoing cardiac interventional procedures.

The use of reflexology intervention among patients following car-

diac interventional procedures may be a favourable intervention.

Although reflexology alone may be inadequate to improve the posi-

tive health outcome and increase health status, we consider that the

findings of this review are important contributions to the scope of

research on reflexology among patients following cardiovascular pro-

cedures and urge need for implementation that increases beha-

vioural, clinical, and proper use of comprehensive health care.

A few limitations in this systematic reviews and meta‐analysis should be addressed. There may be language bias as the RCTs pub-

lished only in English were involved. As only a few studies were

included in the meta‐analysis, the publication bias was not assessed. Other limitations are there was low quality of evidence due to the

unclear risk of bias, inconsistency, and considerable heterogeneity

among included trials.

5 | CONCLUSION

Due to relatively small sample size and low quality of included trials in

this review, it is difficult to conclude on the effect of reflexology on

anxiety among patients undergoing cardiovascular interventional proce-

dures or implications for clinical practice. Very few higher quality RCTs

evaluated the effectiveness of reflexology among patients following car-

diovascular procedures. Hence, rigorous research is needed to prove the

efficacy of reflexology, and higher methodological qualities of RCTs are

necessary for creating strong evidence among patients following cardiac

interventional procedures. Future research must focus on the scientific

rationale of reflexology estimating biomarkers such as endorphins, as the

scientific mechanism is not yet understood clearly.

CONFLICT OF INTEREST

No conflict of interest has been declared by the author(s).

AUTHOR CONTRIBUTIONS

All authors have agreed on the final version and meet at least one

of the following criteria (recommended by the ICMJE [http://www.ic

mje.org/recommendations/]:

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

• Drafting the article or revising it critically for important intellec- tual content.

ORCID

Ramesh Chandrababu http://orcid.org/0000-0001-9481-6489

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How to cite this article: Chandrababu R, Rathinasamy EL,

Suresh C, Ramesh J. Effectiveness of reflexology on anxiety

of patients undergoing cardiovascular interventional

procedures: A systematic review and meta‐analysis of randomized controlled trials. J Adv Nurs. 2019;75:43–53. https://doi.org/10.1111/jan.13822

52 | CHANDRABABU ET AL.

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