6-1 Journal: Article Methods

PAGE 106 JOURNAL OF VASCULAR NURSING SEPTEMBER 2016 www.jvascnurs.net

Evaluation of feasibility and safety of changing body position after transfemoral angiography: A randomized clinical trial

Sina Valiee, PhD, Mohammad Fathi, PhD, Nooshin Hadizade, MD, Daem Roshani, PhD, and Parvin Mahmoodi, MS

From t Kurdista Nursing Kurdista Departm Departm Sanand Univers

Corresp Commit Street, S

Funding Kurdista 31229/1

1062-03

Copyrig

http://dx

Background: Considering the growing number of patients who suffer from cardiovascular and coronary artery disease

and the significant importance of angiography in the diagnosis of coronary artery disease, this study investigated the ef-

fects of position change on the acute complications of coronary angiography.

Methods: This study was a randomized clinical trial. Sixty patients undergoing coronary angiography, which was per-

formed by a single operator were selected by convenience sampling method and were assigned to intervention or control

groups by randomized block design (30 cases in each group). Intervention group patients’ position was changed according

to schedule, whereas patients in the control group remained in the supine position in complete bed rest. At the entrance

hours, 3, 6, 8, and 24 hours after the angiography, patients in both groups were evaluated in terms of vascular complica-

tions, urinary retention, low back pain, groin pain, and comfort. Data were analyzed by repeated measures, Friedman,

Mann–Whitney, chi-square, independent t-test, and Kolmogorov–Smirnov tests with SPSS-22.

Results: The two groups did not show any significant difference in terms of demographic, clinical, and preinterventional

catheterization characteristics (P > 0.05). There was no significant difference with regard to vascular complications

including hematoma (P = 0.149), bleeding (P > 0.01), bruise (P = 0.081), and thrombosis in the two groups of patients

during 5 consecutive reviews. However, there was a significant statistical difference regarding low back pain

(P < 0.001), groin pain (P < 0.001), urinary retention (P = 0.02), and comfort (P < 0.001).

Conclusions: The results of this study showed that changing the positions of patients after angiography based on the

provided program created no change in the incidence of vascular complications (hematoma, bleeding, thrombosis, and

bruise) but resulted in reduced severity of back pain, groin pain, urinary retention, and increased patients’ comfort. (J

Vasc Nurs 2016;34:106-115)

Cardiovascular disease is one of the leading causes of death for women and men of all ethnicities and races,1 and it is ex- pected to remain the most common cause of death in the world until 2020.2 Among heart disease, coronary artery diseases is the most common and life-threatening one.3

he Social Determinants of Health Research Center, n University of Medical Sciences, Sanandaj, Iran; Department, School of Nursing & Midwifery,

n University of Medical Sciences, Sanandaj, Iran; ent of Epidemiology and Biostatistics, Medicine ent, Kurdistan University of Medical Sciences,

aj, Iran; Student Research Committee, Kurdistan ity of Medical Sciences, Sanandaj, Iran.

onding author: Parvin Mahmoodi, MS, Student Research tee, Kurdistan University of Medical Sciences, Pasdaran anandaj, Iran (E-mail: mahmoodi.parvin@muk.ac.ir).

: This work was supported by the Research Council of n University of Medical Sciences (grant number 1035/ 4).

03/$36.00

ht � 2016 by the Society for Vascular Nursing, Inc.

.doi.org/10.1016/j.jvn.2016.05.001

There are different diagnostic methods for assessing coronary artery disease.4 Coronary angiography is the golden standard test to identify the presence and extent of atherosclerotic disease of coronary artery.5 Annually, nearly three million cardiac catheter- izations are done in the United States of America.6 Angiography involves injecting a radiopaque dye into the coronary arteries un- der fluoroscopy which determines the condition of the coronary arteries and the degree of atherosclerosis.

7

Although the risks and complications associated with angiog- raphy depends on the patient’s condition, operator’s skill, and judgment, any invasive procedure has some complications asso- ciated with the procedure.5 Coronary angiography can be ac- cessed via the potential arteries included brachial, radial and femoral arteries.7–11 About 95% of angiography is performed via femoral artery.12,13

Access to the heart via femoral artery can be accompanied with complications such as arrhythmia, vascular complications (bleeding, hematoma, and thrombosis), injury and myocardial ischemia, coronaryartery perforation, hemodynamic collapse, cer- ebrovertebral accident including transient ischemic attack, allergy to contrast media and acute renal failure.14–18 Demonstration of these complications can be divided in two main form of acute and chronic. The former includes hematoma, bleeding, thrombosis, urinary retention, low back pain, and groin pain.5

Studies have shown that to avoid possible complications due to arterial injuries, the current method of treatment after

Vol. XXXIV No. 3 JOURNAL OF VASCULAR NURSING PAGE 107 www.jvascnurs.net

angiography in many health care facilities in Iran is to have the patient rest in the supine position with the head angle of zero de- grees for 8–24 hours and keeping 4 kg (8.82 lbs) sandbag on the catheter insertion site for 6 hours,19–21 which has often been conducted based on tradition and experience.19 This insistence on bed rest for patients after coronary catheterization can lead to restlessness, discomfort, and frequent complaint of back and groin pain.

11 About 42% of patients who get out of bed after

4 hours of rest experience back pain.24 In addition, 11.4% of pa- tients undergoing this procedure may develop urinary reten- tion.14,25 Back pain, groin pain, and urinary retention leads to the use of analgesic medications and urinary catheterization which are associated with their own specific complications. To avoid complications resulting from the use of analgesic medications and urinary catheterization, nonmedical measures and nursing care are appropriate.10

Development of technology along with procedures requires appropriate medical and nursing care.

22,23 Although there is

much evidence for medical approach to care, little evidence exists to support the suggestions relating to management areas such as patient’s position, the time of getting out of bed, and the time of removing sandbag which are generally related to the nursing activities territory.9,24-26 A recent literature review showed that caring of patients undergoing cardiac catheterization requires a revision in key areas of nursing care.19,22,25 Abdollahi et al14 (2013) reported that in addition to changes in body position and leaving the bed early, no vascular complications in patients undergoing coronary angiography was seen, whereas urinary retention in the control group was observed. Rezaei-Adaryani et al

19 (2009) reported that patients

whose positions were switched during the period of bed rest had experiences less fatigue but more comfort and satisfaction in the 3, 6, 8, and 24 hours after arrival to the postangiography ward. In addition, changes in body position had no significant impact on increased bleeding and hematoma compared with the control group.19 Heravi et al27 (2013) comparing the patients in supine positions with the head angle of 0, 15, 30, 45, and 60 in separate groups reported that patients with head angle of 45� had experienced the lowest pain, so it was declared as the best position.

One of the nursing measures is changing the position of the patient who has undergone transfemoral angiography during bed rest, but it is avoided due to the fear of the vascular complications.

The effects of position change in patients after transfemoral angiography during bed rest will be evaluated as it relates to vascular complications. This study aimed to determine the ef- fect of changing position on urinary retention, back pain, pain in the groin, and comfort of patients undergoing coronary angiography.

METHOD

The study is a single-blind randomized clinical trial in two groups which was approved by the Kurdistan University of Medical Sciences research Council. The study’s proposal is registered at (www.irct.com) by the registration number IRCT2015091424018N1.

Sample size and sampling

The samples were chosen by convenience sampling method, and they were randomly allocated into control and intervention groups. The sample size with 95% confidence interval and 80% statistical power was estimated 60 patients (30 patients in the intervention group and 30 patients in the control group) (Figure 1).

Participants

Participants were patients undergoing coronary angiography. Inclusion criteria included nonemergency catheterization, age 18–65 years old, less than 180/100 mm Hg blood pressure, absence of active bleeding disorders, prothrombin time (PT), and partial thromboplastin time (PTT) of less than 16 and 90 sec- onds, respectively, consent to participate in the study, angiog- raphy via the femoral artery, no history of deep vein thrombosis (DVT) before the procedure, not being treated with thrombolytic (not taking streptokinase) and anticoagulant drugs (not taking warfarin), no history of diabetes with sensory prob- lems, not taking any analgesic medications before the procedure, not suffering from peripheral arterial disease, no history of uri- nary problems, no history of allergy to contrast media, no depen- dency to drugs, lack of chronic low back pain, absence of blood and liver diseases. Exclusion criteria included needle entrance more than once to access the artery, cardiopulmonary resuscita- tion during angiography, movement disability, and disorder in the level of consciousness in a way that the patient can not coop- erate to change position and incomplete termination of clinical intervention period.

Ethical considerations

This study was approved by the Research Council of Kurdi- stan University of Medical Sciences with the contract number 1035/31229/14 and was confirmed for ethical considerations by receiving the moral code muk.rec.1394.194 from the ethics com- mittee of Kurdistan University. While explaining the purpose and method of study for the patients, informed consent was obtained from them.

Measuring tool

The instrument used to collect and record information in this was a three-part questionnaire which was designed according to the study.

The first part was demographic and clinical information form which contained information about age, height, weight, gender, marital status, education, occupation, history of smoking, dia- betes, history of previous coronary angiography, systolic and dia- stolic blood pressure, body mass index, PT, PTT, international normalized ratio, and platelet count which was recorded based on the information contained in patients’ medical records.

Patients’ blood pressure was measured and recorded by one person using a mercury sphygmomanometer (ALP K2 model: no 300-VS; Tanaka Sangyo Co, Ltd, Tokyo, Japan) which was calibrated before the start of the study. Their height and weight were measured and recorded by one person using digital scales (Bermend BD7750) and centimeters. The second section con- tained procedural information form which contained the length

Assessed for eligibility (n = 81)

Excluded (n= 15): • Chronic Low Back Pain(n = 6) • unwillingness to participate in

the study(n = 4) • history of taking

anticoagulant(n = 2) • Dependence on opium (n = 3)

Randomized (n = 66)

Allocated to intervention group(n = 33): • Received routine care (n = 33) • Did not received routine care (n = 0)

A llo

ca ti

on

E nr

ol lm

en t

Allocated to control group (n = 33) • Received changing of body

position(n = 33) • Did not receive allocated

intervention(n = 0)

F ol

lo w

u p

Lost to follow up (n =3):

• Had anaphylactic reactions to the contrast agent(n =2)

• Failure to did angiography because of obstruction in abdominal aortic (n =1)

Lost to follow up (n =3): • Had chest pain and take analgesic

medications (n=2) • 3 times needle inserted to access

artery (n =1)

A na

ly si

s

Analyzed (n =30) Analyzed (n =30)

Figure 1. Consolidated Standards of Reporting Trials (CONSORT) flow diagram.

PAGE 108 JOURNAL OF VASCULAR NURSING SEPTEMBER 2016 www.jvascnurs.net

of angiography, homeostasis time, size of the catheter used, injury of the femoral artery, and the type and volume of contrast agent, diagnosis of coronary artery stenosis which were prepared using a chronometer and the information contained in patient records.

Part three of the evaluation form included angiographic com- plications such as hematoma, bleeding, urinary retention, back pain, groin pain, and comfort. Back pain, groin pain, and comfort were measured and recorded with standard numeric rating scale.28 Patients’ comfort level was measured by a general ques- tion about the overall level of comfort at the time of measure- ment. The patients were asked to rate their comfort from 0 to 10 grades. The validity of this scale was set by Johnson and Carol.22 The reliability was estimated by Farrar et al and Good et al to be 0.78 and 0.83.29,30 Hematoma shape and bruise was placed on transparent paper and then on graph paper, and the side of intended shape was measured and recorded (based on the biggest length and width) per square centimeter. The amount of bleeding was measured by weighing Gauze soaked in blood by 0.1 gm sensitive Japanese scale (standard future). Urinary retention was also analyzed based on patient interview. All the measurements were carried out by the principal researcher.

Intervention procedures

After the selection of eligible patients for inclusion into the study and providing the necessary explanations, obtaining informed consent, necessary data were obtained from medical re- cords, and blood pressure was measured and recorded. The pa- tients were randomly entered into to the intervention group. After controlling patients’ vital signs and marking dorsal pedis and posterior tibialis pulses on their feet, the patients were entered in the angiography catheterization room. On completion of angiography and exiting the catheterization laboratory, the sheath was removed by cardiology nurses, mechanical or manual homeostasis was applied on the insertion site until the blood coagulated. The time hemostasis was measured by stopwatch, and it procedural information was recorded based on the case.

After hemostasis, 2 folded 4 � 4 (4 cm length and width) gauzes was put on the catheter site (the reason of making the gauzes 2 folded was to expose the catheter insertion site to the maximum extent possible for ease of evaluating complications). Transparent bandage covered the dressing to check for the ease in monitoring for hematoma and bleeding. Then, two 4 kg (8.82 lbs) sandbags were placed on the site, and the second sandbag was removed after stabilization of the patient. The patient came to the postangiography ward with only one sandbag. After entering

TABLE 1

PROTOCOLS OF BODY POSITION AND METHODS OF ANALYSIS IN THE GROUPS

Group 1st & 2nd hour 3rd & 4th hour 5th hour 6th hour 7th & 8th hour 9th hour 24th hour

Intervention Group

Supine Supine, HOB Right side, HOB Left side, HOB Sitting position OOB OOB

45� El 15� El 15� El Control group Supine Supine Supine Supine Supine OOB OOB

HOB = head of bed; EL = elevation.

Vol. XXXIV No. 3 JOURNAL OF VASCULAR NURSING PAGE 109 www.jvascnurs.net

the control group patients to the postangiography ward routine, cares were performed. The patient was immobile in the supine position, with head angle of zero degree, 8 hours complete bed rest, and 4 kg (8.2 lbs) sandbags was put on the site where the catheter was inserted for 6 hours.

After entering the intervention group patients to the post angiography ward, the patient had 8 hours complete bed rest, 4 kg sandbag was put on the site where the catheter was inserted for 6 hours, but changing position was applied while taking rest in the bed for 8 hours (Table 1). During the first and second hours, the patient was kept in the supine position and the head angle of zero degree. During the third and fourth hours, the patient was kept in the supine position with the head angle of 45�. During the fifth and sixth hours, the patient was lying on the left or right side with the head angle of 15� and in the seventh and eighth hour the patients were cared in the sitting position (Table 2). The third part of the questionnaire was measured and recorded immedi- ately after entering the ward, third, sixth, eighth, and 24th hours later (before discharge from the ward; Table 2).

Statistics

After collecting data to assess the normal distribution of data, Kolmogorov–Smirnov test was used. To compare the two inter- vention and control groups in terms of demographic, clinical, and procedural quality, chi-square and Fisher’s exact tests were used. Moreover, to compare quantitative variables independent t-test and Mann–Whitney tests were used.

RESULTS

Eighty-one patients were assessed for inclusion criteria. Some patients were excluded from the study for the following reasons including; three patients because of a history of chronic low back pain, four patients because of an unwillingness to participate in the study, two patients because of the history of anticoagulant, and three patients due to taking opium. Thirty- three patients were assigned to each group. During the study, in the intervention group, two patients were excluded from the study due to chest pain and taking analgesic and one patient due to needle entrance to the arteries more than once. In the con- trol group, two patients were excluded due to anaphylactic reac- tions and one patient due to stenosis in the abdominal aorta. Finally, two groups (n = 30, each group) were analyzed. There was no significant difference between the two groups of

participants in terms of demographic and clinical data include of mean age, height, weight, systolic blood pressure, diastolic blood pressure, body mass index, PT, PTT, platelet count, inter- national normalized ratio, homeostasis time length, contrast me- dia volume, amount of smoking, marital status, education level, smoking history, history of diabetes, history of previous coronary angiography, rupture of the femoral artery, final diagnosis, recommend treatment, and the amount of stenosis in the right coronary, left main coronary, left circumflex arteries, and the two groups were homogenous (Tables 3 and 4). But in terms of gender, occupation, catheter size, type of contrast, the stenosis of left anterior descending artery, and duration of angiography were significantly different (Tables 3 and 4). The mean age of the patients was 10.445 � 57.71, and 34 patients (56.66%) were male and 58 (96.65%) were married.

The results showed that the incidence of hematoma between the two groups was not significant. Moreover, hematoma in the intervention group (P = 0.006) was significantly different at different times, but in the control group (P = 0.149), the differ- ence was not significant (Table 4).

Considering the P values in Table 5, to compare between intervention and control groups at different times, there were no significant differences between the intervention and control groups in terms of hematoma (Table 5).

The results showed that the incidence of urinary retention in the control group (P = 0.023) and intervention group (P = 0.020) were significantly different at different times (Table 4). With re- gard to the P values in Table 5, pairwise comparison between intervention and control group at different times, there were no significant differences between the intervention and control groups in terms of complications of urinary retention (Table 4).

Furthermore, the incidence of thrombosis remained un- changed at different times and was not observed in none of the participants.

In addition, the incidence of bleeding was significantly different in terms of time (P $ 0.001). The test results of Bonfer- roni procedure showed that in the control group at third, eighth, and 24th hours were not significantly different in terms of the mean of this variable and in the intervention group there was a significant difference only between the time of entrance and the other times.

The results showed that the incidence of bruise between the two groups in different measurements did not differ significantly in terms of time (P = 0.081).

TABLE 2

DISTRIBUTION OF UNITS IN TERMS OF VARIABLES

Variable Group Mean � SD P value

Age* Control 56.56 � 9.15 0.401 Intervention 58.86 � 11.74

Heighty Control 164.16 � 11.31 0.151 Intervention 166.16 � 12.58

Weight* Control 74.88 � 21.67 0.52 Intervention 77.43 � 22.64

The number of cigarettes smoked per dayy

Control 8.1 � 4.1 0.076 Intervention 9.15 � 56.56

No. of previous angiographyy Control 0.66 � 0.33 0.076 Intervention 16.36 � 0.1

Systolic blood pressurey Control 122.26 � 19.11 0.653 Intervention 123.33 � 14.93

Diastolic blood pressure y

Control 74.03 � 11.58 0.583 Intervention 75.33 � 8.6

Volume of contrast dyey Control 51.33 � 23 0.564 Intervention 51.33 � 22.55

BMI y

Control 55.99 � 36.64 0.6 Intervention 26.34 � 3.62

PTy Control 11.73 � 0.86 0.364 Intervention 11.56 � 0.93

PTT y

Control 31.7 � 3.00 0.298 Intervention 33.1 � 6.7

Plt count* Control 245230 � 9.15 0.298 Intervention 250610 � 80.01

INRy Control 17 � 1.15 0.292 Intervention 1.14 � 0.28

Duration of hemostasis periody Control 7.95 � 3.69 0.603 Intervention 6.41 � 1.67

Duration of angiography periody Control 23.78 � 10.51 0.031 Intervention 245230 � 9.15

BMI = body mass index; INR = international normalize rate; PT = protrombin time; Plt count = platelet count; PTT = partial thromboplastin time.

*T independent. yMann–Whitney.

PAGE 110 JOURNAL OF VASCULAR NURSING SEPTEMBER 2016 www.jvascnurs.net

The results showed that the incidence of groin pain was significantly different in terms of time (P > 0.001). The results of Bonferroni for comparing sampling time between the inter- vention and control groups showed that during the study period except at zero and 24th hour the difference was significant in terms of intended complication.

The results showed that the incidence of comfort (based on numeric rating scale) had a significant difference in terms of time in this complication (P = 0.001). Bonferroni procedure

for pairwise comparisons of the sampling time between the intervention and control groups during the study period showed a significant difference except for the time of admission and 24th hour. Moreover, there was a significant difference for the incidence of back pain in terms of time. Bonferroni for pairwise comparisons of the sampling time between the intervention and control groups during the study period showed a significant dif- ference in terms of comfort except for the time of entrance and 24th hour.

TABLE 3

DISTRIBUTION OF SUBJECTS BASED ON QUALITATIVE VARIABLES BETWEEN THE TWO GROUPS OF CONTROL AND INTERVENTION

Variable Subgroup Intervention Control P value

Gender** Male 22 12 0.009

Female 8 18

Marital status** Married 30 28 0.492

Single 0 1

Widow 0 1

Divorced 0 0

Education** Illiterate 22 18 0.445

Under diploma 7 9

Diploma 1 3

Academic 0 0

Job status** Clerk 2 1 0.002

Self-employed 19 6

Retired 3 4

Housewife 6 18

Unemployed 0 1

Smoking history* Has 17 8 0.018

Has not 13 22

Diabetes record* Has 7 9 0.559

Has not 23 21

Angiography history**

Has 1 6 0.103

Has not 29 24

Catheter size** F400 1 0 0.006 F500 1 0 F600 20 29 F700 8 1

Rupture of the femoral artery**

Has 0 0 1.00

Has not 30 30

Type of contrast media**

Meglumine 14 20 0.019

Visipaque 16 7

Meglumine and Visipaque

0 3

Disease diagnosis* NECA 10 16 0.425

1VD 2 2

2VD 12 7

3VD 6 5

Significance stenosis of coronary arteries

*RCA 9 7 0.559

**LMCA 1 0 1.00

*LAD 14 6 0.028

**LCX 4 8 0.333

(Continued)

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TABLE 3

CONTINUED

Variable Subgroup Intervention Control P value

Urinary retention***

Has 9 10

Has not 21 20

F00 = French; NECA = normal epicardial coronary arteries; 1VD = one vessel disease; 2VD = two vessel disease; 3VD = three vessel disease; RCA = right coronary artery; LMCA = left main coronary artery; LCX = left circumflex artery; LAD = left anterior descending.

Chi-square test**, Fisher exact test*, and Friedman test*.

PAGE 112 JOURNAL OF VASCULAR NURSING SEPTEMBER 2016 www.jvascnurs.net

DISCUSSION

The findings of this study showed that changes in body posi- tion after angiography did not create a change in the incidence of vascular complications including hematoma, bleeding, throm- bosis, and bruising compared to the control group, whereas uri- nary retention was reduced. In addition, changing body position reduced back pain, groin pain, and finally improved the comfort of the patient.

Other studies finding agree with the results of this study and a significant difference in the incidence of complications after cor- onary angiography at the catheter insertion site between the inter- vention and control groups was not reported. For example,

TABLE 4

RESULTS OF ACUTE COMPLICATIONS

Variable Group Hour 0 Hour 3rd

Hematoma* Control 1.07 � 3.23 1.07 � 3.23 Intervention 0.43 � 2.19 0.43 � 2.19

Urinary retention* Control 2 1.93 � 0.25 Intervention 1.93 � 0.25 2.56 � 3.68

Bruise y

Control 1.08 � 3.37 1.1 � 3.37 Intervention 0.35 � 1.82 0.36 � 1.82

Bleeding y

Control 0 0.01 � 0.07 Intervention 0 0.01 � 0.05

Back painy Control 2.74 � 2 3.1 � 4.46 Intervention 2.66 � 1.6 3.3 � 2.83

Groin painy Control 0.26 � 0.63 3.1 � 2.57 Intervention 0 1.03 � 2.04

Comforty Control 9.66 � 1.82 7.6 � 2.48 Intervention 10 9.06 � 1.7

Thrombosisy Control 0 0 Intervention 0 0

*Friedman test. yRepeated measures test.

Abdollahi et al (2015) studied the simultaneous effects of early ambulation (4 hours of bed rest) and changes in body position with a different protocol from this study. The time points for analyzing the patient in terms of complications were different. In their study, no hemorrhage and hematoma was reported. It was found that changes in body position in and early ambulation after coronary interventions did not increase the vascular complications.14

Furthermore, the results indicated that changes in body posi- tion had no impact on the incidence of acute vascular complica- tions, including hematoma and bleeding. Moreover, Yeganeh Khah et al (2012) compared the effect of different ways of chang- ing patients’ position on the vascular complications of after

Hour 6th Hour 8th Hour 24th Sig

0.61 � 1.78 0.31 � 0.97 0.08 � 0.43 0.006 0.33 � 1.64 0.1 � 0.40 0 0.149 1.83 � 0.37 1.76 � 0.43 1.8 � 0.4 0.023 1.8 � 0.4 1.7 � 0.46 1.9 � 0.25 0.02

1.03 � 3.18 0.8 � 2.54 0.12 � 0.45 0.081 0.16 � 0.73 0.026 � 0.14 0.026 � 0.14 2.3 � 12.77 0.16 � 0.54 4.38 � 7.56 0.001>

0.01 � 0.03 0.11 � 0.19 5.34 � 4.59 3.14 � 5.8 3.26 � 4.03 1.85 � 0.43 0.001> 3.14 � 2.3 2.75 � 1.56 0 4.86 � 3.08 3.7 � 2.74 2.36 � 2.20 0.001> 1.96 � 2.37 1.86 � 2.16 1.66 � 2.45 6.03 � 2.2 6.6 � 2.4 8.63 � 1.67 0.001> 8.5 � 2.2 7.9 � 2.39 8.9 � 2.15

0 0 0 0

0 0 0 0

TABLE 5

MANN–WHITNEY TEST TO COMPARE THE GROUPS TWO BY TWO IN TERMS OF STUDY TIME

Variable Measurement time P value

Hematoma Entrance time 0.317

Third hour 0.579

Sixth hour 0.394

Eighth hour 0.222

24th hour 0.222

Urinary retention Entrance time 0.312

Third hour 0.563

Sixth hour 0.741

Eighth hour 0.977

24th hour 0.154

Vol. XXXIV No. 3 JOURNAL OF VASCULAR NURSING PAGE 113 www.jvascnurs.net

coronary angiography and reported that none of the patients developed bleeding and arterial occlusive and no significant dif- ference between intervention and control groups were observed in changing body position.

Rezaei-Adaryani et al (2009) compared the effect of three different body positions including the supine position, changing the head angle and changing side by side in three separate groups and found that changing body positions did not have an impact on the amount of bleeding and hematoma of the two groups at different times after angiography.19 This study was different from Adaryani study because it was a comparative study con- ducted on two groups, and different body positions were used, but the findings were consistent with the Adaryani study. Acute vascular complications after coronary angiography are hema- toma, bleeding, and thrombosis.14–18

Farmanbar et al (2012) studied changes in body position and duration of bed rest in two separate groups. Fisher’s exact test showed no significant difference between the two groups. In this study, patients had sandbags just for 2 hours and after 4 hours changing position they got out of bed. Three patients in the con- trol group and one patient in the experimental group had hema- toma. One case of bleeding in the control group and one in the intervention group were reported as well.

31 However, in this

study, the effect of changing position was studied not only on the complications but also on back pain, groin pain, urinary retention, and comfort, and the rate of incidence of complications was lower. Nyshabouri and Ashke-e-torab (2007) studied the ef- fect of changing the bed angles on the incidence of vascular com- plications and reported no case of hematoma, bleeding, and thrombosis among the groups.32 In this study after two hours of rest in the supine position, the patient’s head angle was in 45� because in previous studies the lowest amount of complica- tions was in this position. Therefore, changing body positions in the bed based on the presented method had no effect on the

incidence of vascular complications such as hematoma, bleeding, and thrombosis and did not make any complications in the pa- tients. Based on several studies, movement limitations and com- plete bed rest resulted in frequent complaint of low back pain.14

As a result patients request for analgesic and changing position frequently to resolve the pain in the bed.19 Therefore, relieving pain and providing patient comfort without increasing vascular complications after coronary angiography is one of the nursing goals.13

Yilmaz et al (2007) in Turkey studied the effect of sandbags and changing the patient’s position on the incidence of vascular complications, and they claimed that there was no difference be- tween the groups of patients who had or had not sandbag on the site of catheter insertion. However, the pain severity in the group who had changing positions was by far less than the other group which is consistent with the findings of our research. Moreover, there was no significant difference between the two groups in the second hour which was not in accordance with our findings

21

because in Yilmaz et al study the sandbag was on the site of cath- eter insertion for two hours and a half, whereas in our study it was 6 hours.

To compare changes in bleeding, bruise, back pain, groin pain, comfort, and thrombosis over time within groups repeated measures test was used and if the difference was significant Bon- ferroni test was used. To compare changes regarding hematoma and urinary retention over time within groups Friedman test was used, and for pairwise comparison of intervention and control groups Mann–Whitney test was used based on distinct time of study.

Back pain and urinary retention were observed as common complication in looking after patients undergoing angiography. Relying on noninvasive methods to empty the bladder is prefer- able because bladder catheterization increases the risk of urinary tract infection.22 Abdolahi et al (2015) in a study regarding changing positions compared the control and experimental groups with a different protocol from this study and found that no significant differences exist between the two groups in terms of complications of urinary retention14 which is consistent with our study. Pairwise comparisons of sampling time showed that there was significant difference in terms of the intended compli- cation between intervention and control groups during the study period except at zero and 24th hour which was probably due to the reason that at the zero hour patients in both groups were in supine position with head angle of zero degree and at 24th hour both groups were out of bed and as a result due to the equality of body position, it is expected that the difference did not become significant.

Changing body position in the bed improves the patient’s comfort.13 Many teams emphasizes on immobilitzation to avoid bleeding, which can cause patient comfort Rezaei-Adaryani et al

19 (2015) in a study regarding changing positions compared

the control and experimental groups with a different protocol from this study and found that the intervention group had signif- icantly more comfort at third, sixth, eighth hours, and the morn- ing after angiography compared with the control group which was consistent with our study.19 Change in body position based on the proposed manner resulted in decrease in lower back pain, groin pain, urinary retention, and increase in comfort.

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Limitations and suggestions for future research

It is recommended that in future studies analyze the impact of early ambulation, the duration of keeping sandbag on the catheter insertion and sandbags with different weights on the incidence of acute and chronic complications at different time points from this study, to improve care after coronary angiography.

CONCLUSIONS

The results of this study showed that changing position after angiography based on the method provided, without change in the incidence of vascular complications (hematoma, bleeding, thrombosis, and bruise) reduced the severity of back pain, groin pain, urinary retention, and improved patients’ comfort. By changing position in bed after coronary angiography, nurses can increase patients’ comfort. New nurses tend to be cautious and the more seasoned nurses adhere to routine. Therefore, it is recom- mended that cardiology and postangiography ward nurses, use the position change based on the present study. Interventionalist and nurse comfort play a role in patient comfort and reposition. Inter- ventionalists will need to address any postprocedural complica- tion for patients which may affect the level of their comfort. We can reduce the complications including urinary retention, discom- fortback and groin pains by positionchange. So by decreasing the- ses complications, the interventionalists comfort will increase due to lower discuses about postprocedural complications and their high level of comfort affect patients comfort.

ACKNOWLEDGMENTS Hereby, the authors want to appreciate the Deputy of Research at Nursing and Midwifery faculty of Kurdistan Uni- versity of Medical Sciences, angiography and cardiac ward’s staff at Tohid Hospitals affiliated with Kurdistan University of Medical Sciences and all those patients who have helped us in this study. This study entitled the Comparative Study of the Effects of Sand Bag Keeping Time and Changing Body Posi- tion on Acute Complications of Coronary Angiography in Referring Patients to the Sanandaj Tohid Hospital, 2015 is a part of MS thesis of Parvin Mahmoodi which is approved in Kurdistan University of Medical Sciences.

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