Applied Nursing Research 33 (2017) 142–148

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Applied Nursing Research

journal homepage: www.elsevier.com/locate/apnr

The Effect of Progressive Muscle Relaxation on Glycated Hemoglobin and

Health-related Quality of Life in Patients with Type 2 Diabetes Mellitus☆
Tahereh Najafi Ghezeljeh, PhD, Assistant Professor a, Maryam Kohandany, MSc b,⁎,
Fateme Hagdoost Oskouei, PhD, Professor c, Mojtaba Malek, MD, Associated Professor d
a
Center for Nursing Care Research, Department of Critical Care Nursing, School of Nursing and Midwifery, Iran University of Medical Sciences, Rashid Yasemi St., Valiasr St., Tehran, Iran
b
Medical-Surgical Nursing, School of Nursing and Midwifery, Iran University of Medical Sciences, Tehran, Iran
c
Center for Nursing Care Research, Department of Public Health, School of Nursing and Midwifery, Iran University of Medical Sciences, Tehran, Iran
d
Institute of Endocrinology and Metabolism Research and Training Center, Iran University of Medical Sciences, Tehran, Iran

a r t i c l e i n f o a b s t r a c t

Article history: Aim: This study aimed to evaluate the effect of Jacobson’s progressive muscle relaxation (PMR) on glycated hemo-
Received 4 July 2016 globin (HbA1c) levels and health-related quality of life (HRQoL) in patients with type 2 diabetes mellitus (DM).
Revised 3 October 2016 Background: Due to relatively poor HRQoL in patients with type 2 DM, different stress reduction techniques was
Accepted 6 November 2016 applied to improve physical and mental health in these patients.
Available online xxxx
Methods: This randomized controlled clinical trial was conducted at the Diabetes and Endocrinology Institute of
Firoozgar Hospital, Tehran, Iran, between June and December 2015. Sixty-five patients with type 2 DM were ran-
Keywords:
Diabetes type 2
domly divided into the control (n=35) and PMR (n=30) groups. The patients of the control group only received
Glycated Hemoglobin the conventional care. The PMR group practiced Jacobson’s PMR at home for 12 weeks and were monitored by
Health-related Quality of Life the researcher’s phone calls and patient’s self-report list. For both groups, Iranian Diabetes Quality of Life Brief
Progressive Muscle Relaxation Clinical Inventory (IDQoL-BCI) questionnaire was completed and HbA1c levels were measured before and 12
weeks after study entry.
Results: The results showed that there were no significant differences in terms of HbA1c levels and HRQoL scores
between the PMR and control groups 12 weeks after intervention. However, in the PMR group, the intervention
led to a significant reduction in HbA1c levels (P=0.04) and a significant increase in total HRQoL score (P=0.045)
and its psychosocial dimension (P=0.019).
Conclusion: PMR had no significant impact on HbA1c levels and HRQoL in patients with type 2 DM. Further studies
with larger sample size and longer follow-up are needed to improve QoL in patients with type 2 DM.
© 2016 Published by Elsevier Inc.

1. Introduction
Diabetes mellitus (DM) as one of the most common chronic diseases
is the leading cause of death and disability worldwide, suggesting DM
imposes a substantial burden on society and healthcare system (Sajadi
et al., 2012). In Iran, it has been estimated that more than 4,581,600 in-
dividuals had DM in 2014, while the approximate number of undiag-
nosed diabetes in adults were 2,290,800 individuals, among whom
90% of individuals had type 2 DM (International Diabetes Federation
Middle East and North Africa, 2015; International Diabetes Prevention
and Control Foundation, 2015).
Major fluctuations in blood glucose, diet and exercise restrictions,
physical disability and development of vascular disorders are known as
☆ (Code trial No. IRCT2015021821134N1)
⁎ Corresponding author.
E-mail addresses: najafi.t@iums.ac.ir (T. Najafi Ghezeljeh),
maryam_kohandany@outlook.com (M. Kohandany), Oskouei.f@iums.ac.ir (F.H. Oskouei),
malek.m@iums.ac.ir (M. Malek).
the factors affecting diabetes, indicating this disease is closely associated
with stress level (Safavi, Samadi, & Mahmoodi, 2013). Furthermore, the
daily management of DM can cause high level of stress, and continuous
stress leads to anxiety and depression in these patients (Australian
Diabetes Council, 2013). It is noted that the body responds to stress by
releasing various hormones that neutralize the effects of insulin,
resulting in insulin resistance. Stress causes to eat more and exercise
less (Mcculloch, 2008) and is related to low quality of life and health
perception (Morewitz & Goldstein, 2007).
Health-related quality of life (HRQoL) refers to social, physical and
emotional well-being levels in a patient undergoing medical treatment
(Fairclough, 2010). A number of studies have reported lower HRQoL in
patients with type 2 DM as compared to healthy people (Acton, 2013;
Saadatjoo, Rezvanee, Tabyee, & Oudi, 2012). One of the major factors af-
fecting HRQoL in these patients is psychological stress due to continu-
ous self-management. Therefore, reducing diabetes-related distress is
most likely to be an important predicting factor for improving HRQoL
in patients with type 2 DM (Tol et al., 2015). High percentatge of pa-
tients with DM affected by depression and less attention was paied to

http://dx.doi.org/10.1016/j.apnr.2016.11.008
0897-1897/© 2016 Published by Elsevier Inc.
 T. Najafi Ghezeljeh et al. / Applied Nursing Research 33 (2017) 142–148
their psychological issues (Nejati Safa, Larijani, Shariati, Amini, &
Rezagholizadeh, 2007). A study has also showed that it is important to im-
prove HRQoL level in patients with type 2 DM (Javanbakht, Abolhasani,
Mashayekhi, Baradaran, & Jahangiri Noudeh, 2012). One of the duties of
nurses is to improve the stress responses in these patients through the
appropriate and effective interventions (Yoost & Crawford, 2015). Un-
derstanding of complementary therapies and application of relaxation
techniques are a part of comprehensive nursing care, for which all
nurses should be trained and educated. There are various relaxation
techniques to reduce muscle tension in the body (Snyder & Lindquist,
2010). Relaxation techniques for diabetes are based on the fact that
stress stimulates liver cells to release glucose that leads to increased in-
sulin resistance, so these methods can reduce stress and create a state of
relaxation in diabetes (Dunning, 2007).
Progressive muscle relaxation (PMR) is a technique to relax the
muscles by regulating muscle tension throughout the body
(Seaward, 2011). Edmund Jacobson described the PMR technique
in 1935. He believed that the body responds to disturbing thoughts
and stressful events by increased muscle tension. In Jacobson’ PMR,
it is trained to tighten a group of muscles and then slowly releases
while focusing on the feeling of muscle tightness and relaxation. In
original model of PMR, a patient learns how to tighten gradually
the sixteen muscle groups of body, then exhales slowly before
relaxing each muscle group (Dossey, Keegan, Barrere, & Helming,
2015). This method is simple and requires neither special training
nor prior experience.
In a study, touch massage therapy and PMR technique have been
compared in patients with type 2 DM, and it has been showed that
both methods had no effects on HRQoL of these patients (Wandell,
Carlsson, Gafvels, Andersson, & Tornkvist, 2011). However, another
study on 158 black women with type 2 DM living in South Africa
has reported that PMR improved the QoL of these patients (Van
Rooijen, Rheeder, Eales, & Becker, 2004). In addition, a study has in-
dicated that both massage therapy and PMR had positive effect on
reducing blood sugar and glycated haemoglobin (HbA1c) levels in
children with type 1 DM as compared to the control group
(Ghazavi, Talakoob, Abdeyazdan, Attari, & Joazi, 2008). However,
the combination of relaxation method (such as muscle relaxation,
deep breathing exercises and guided imagery) and music had no ef-
fect on HbA1c levels, whereas there was a significant reduction in
fasting blood sugar (FBS) (Khoshkhou, Bakhshipoor, Dashipour, &
Keramati, 2010). Also, it has been found that PMR caused a signifi-
cant decrease in anger and FBS among patients with types 1 and 2
DM as compared to the control group (Asadi, Tirgari, &
Hasanzadeh, 2013).
In a systematic review on 25 articles, the results of 12 studies have
showed that cognitive-behavioral techniques (CBT) may reduce
HbA1c levels and psychological distress in patients with type 2 DM;
however, there are a lot of weak evidences in this regard (Ismail,
Winkley, & Rabe-Hesketh, 2004). A meta-analysis has indicated that
CBT as a psychosocial intervention has been recently developed and is
still in the beginning stages. This technique may slightly reduce blood
glucose in children and adolescents but shows no effects on adults
(Winkley, Landau, Eisler, & Ismail, 2006). However, it is essential to con-
duct more randomized clinical trials (RCTs) based on standards for high
quality researches in order to examine the effect of various complemen-
tary interventions on different groups of people with diabetes (Alam,
Sturt, Lall, & Winkley, 2009; Winkley et al., 2006). The results of a recent
systematic review showed that CBT may be effective on the care of pa-
tients with DM. Also limited studies was investigated the effect of CBT
on HRQoL in patients with DM and few studies were conducted in
United Kingdom, and Africa and Asian countries, indicating more re-
search is necessary for increasing the generalizability of findings
(Uchendu & Blake, 2016).
This study aimed to evaluate the effect of Jacobson’s PMR on HbA1c
levels and HRQoL in patients with type 2 DM.
143
2. Materials and Methods
2.1. Type of study
This study was a randomized controlled clinical trial that was con-
ducted at the Diabetes and Endocrinology Institute of Firoozgar Hospital,
Tehran, Iran, between June and December 2015.
2.2. Ethical consideration
This study was approved by the Ethics Committee of Iran University
of Medical Sciences (93/D/105/5864). The purpose of the study was fully
explained to all participants before they signed a written informed con-
sent form, in which they granted permission for taking blood samples.
Furthermore, the confidentiality of their information was protected, and
the results of the study were then released to them. Also, it was empha-
sized that if the participants were not willing to cooperate, their deci-
sions would not affect the treatment process.
2.3. Study population
The subjects in this study were patients with type 2 DM who were re-
ferred to the Diabetes and Endocrinology Institute of Firoozgar Hospital.
The inclusion criteria were as follows: (i) age between 35 and 65
years, (ii) literacy skills, (iii) definitive diagnosis of type 2 DM by a doc-
tor, (iv) history of taking oral anti-diabetic drugs for at least 1 year,
(v) absence of chronic complications of DM (such as cardiovascular dis-
ease, retinopathy, chronic renal failure, and diabetic foot), (vi) no signs
of mental illness (not taking psychiatric drugs), (vii) no sensory-
perceptual and communication problems, (viii) no movement disorders
and injuries of the extremities, (ix) no addiction and (x) no history of
PMR training. Furthermore, the exclusion criteria were as follows:
(i) failure to attend in one of the training sessions, (ii) lack of ability
and skill to learn the technique, (iii) failure to complete 10 sessions of
the PMR technique during a week at home (failure to complete the
self-report list), (iv) change in the drug regimens, (v) use of other com-
plementary therapies during the research, (vi) presence of severe com-
plications of DM, and (vii) facing stressful events during the study (like
death of family member). The sample size was calculated with a 95%
confidence interval and 80% power, assuming that relaxation method
could improve HRQoL score in the PMR group as compared to the con-
trol group at the effect size of d= 6. A sample size of 28 patients in each
group was then estimated using the following formula:
 2
Z 1−2a þ Z 1−β  2S2
x¼ 2
d
With a 25% drop-out rate, a sample of 35 patients in each group was
considered (a total sample size of about 70 individuals). The standard
deviation (SD) of 8 was also considered according to the studies by
Dudzinska et al. (2012) and Ghazavi et al. (2008). Of 70 patients partic-
ipating in this study, 5 patients were excluded from the PMR group for
missing the second educational session (2 patients) and increasing
drug dose (3 patients). Therefore, the data of 65 patients were analyzed.
The flow chart of study population selection is shown in Fig. 1.
2.4. Random allocation
The samples (n=65) were allocated into the PMR (n=30) and con-
trol (n=35) groups using fixed blocked randomization with block size
of 4 in ratio of 1: 1. Therefore, different possible combination of groups
were written on the separate cards, placed in sealed envelopes and kept
in a box. Then a sealed envelope was removed from the box and opened
to determine the patient’s group. A nurse who was blinded to the study
took the sealed envelopes out of the box. After all the sealed envelopes
144 T. Najafi Ghezeljeh et al. / Applied Nursing Research 33 (2017) 142–148

Patients (n=241)

Enrollment
Excluded (n=0)
Not meeting inclusion criteria (n=171)

Randomized (n= 70)

Allocated to the PMRgroup (n= 35) Allocated to the control group (n= 35)
Allocation Received no PMR training (n= 35)
Received PMR training (n= 33)

Excluded (n=5)
Excluded (n=0)
Increasing drug dose (n=3) Follow-Up
Missing the second educational session (n=2) Lost to follow up (n=0)

Analyzed (n=30) Analyzed (n= 35)

Analysis Excluded from analysis (n=0)
Excluded from analysis (n=5)

Fig. 1. Flow chart of study population selection and research process.

were opened, the nurse put them back into the box again, and this trend groups received the conventional educational courses and medication
continued to achieve the desired sample size. regimen provided by the center.

2.5. Intervention 2.6. Data collection

PMR is a technique for tightening and relaxing of 16 muscle groups
of the body along with deep breathing when the muscles are relaxed.
This technique alternately tightens up and relaxes the following muscle
groups: (1,2) forearm muscles, (3,4) arm muscles, (6,5) lower leg mus-
cles, (7,8) upper leg muscles, (9) stomach muscles, (10) chest muscles,
(11) shoulder muscles, (12) neck muscles, (13) muscles of mouth, jaw,
throat, (14) eye muscles, (15) lower forehead muscles and (16) upper
forehead muscles. This technique shows how to focus on a muscle
group, tighten up for 10 seconds and then relax for 20 seconds. It is
very important to breathe properly while tightening up the muscles
(Bourne, 2010). One of the researchers who was already well trained
for PMR gave the Jacobson's PMR training (demonstration, face to face)
to patients in the PMR group for a week on two consecutive days in
the morning for 45-60 minutes. In the first session, the different muscle
groups in the body, deep breathing, and preparation before practicing
the technique were described, while the procedure was demonstrated
practically. In the second session, the patient was asked to do the proce-
dure, while the researchers gave feedback during the practice. A week
later, there was a problem-solving session. Finally, the researcher en-
sured that everyone learned the Jacobson's PMR technique. Also, an ed-
ucational pamphlet and a training CD (a description of the steps of PMR
technique) were given to all patients of the PMR group. Then, the pa-
tients were asked to practice at home twice a day for 15 minutes for
12 weeks (Khoshkhou et al., 2010; Surwit, Bauman, & Skyler, 2013).
The patients were closely monitored and guided by a researcher
through the phone calls during 12 weeks. They were also asked to
keep a daily self-report list of adherence to PMR technique in order to
calculate the mean frequency of the practice per day. Patients of both
Data collection consisted of three parts as follows: (i) baseline de-
mographic information collected through reviewing the patient's medical
records or interviewing the patient was completed before the interven-
tion, (ii) HbA1c levels (primary outcome) were measured before and 12
weeks after intervention using DS5 system (Drew Scientific Inc., USA),
indicating that HbA1c level b 6 (good control of diabetes), ˃7 to ≤ 9 (av-
erage control of diabetes) and ˃9 (poorly control of diabetes) (Cornet,
Stoicu-Tivadar, & Horbst, 2015), as well as (iii) Iranian Diabetes Quality
of Life Brief Clinical Inventory (IDQoL-BCI; second outcomes) including
15 questions was completed before and 12 weeks after study entry
(Burroughs, Radhika, Waterman, Gilin, & Mcgill, 2004).
2.7. Measurement tools
IDQoL-BCI with 5-point Likert scale is presented in two general for-
mats as follows: (i) the negative health-related impact following diag-
nosis and treatment is scored on the scale ranging from 1= “Never” to
5= “Always” and (ii) the positive health-related impact following diag-
nosis and treatment is scored on the scale ranging from 1= “Very Satis-
fied” to 5 =“Very Unsatisfied” (Burroughs et al., 2004). This
questionnaire includes three parts. Part one including the questions
1,2,3,6, and 7 is related to the disease problems; part two including
questions 11,12,13,14, and 15 is related to the diagnosis and follow-up
treatment; and part three including questions 4,5,8,9, and 10 is related
to the psychosocial effects of the disease. Total scores are between 15
and 75, meaning the highest score indicates poor HRQoL. In addition,
it only takes 10 minutes to complete the questionnaire (Mirfeizi et al.,
2012). A Cronbach's alpha of 0.77 has been reported for IDQoL-BCI
 T. Najafi Ghezeljeh et al. / Applied Nursing Research 33 (2017) 142–148 145

that indicates good reliability and validity of this questionnaire Table 1

(Nasihatkon et al., 2012). Furthermore, for the present study, Comparison of sociodemographic characteristics between the study groups.

Cronbach's alpha was calculated 0.71 that suggested the internal consis- Groups Control PMR P
tency of the questionnaire. Before study entry, the patients of both Demographic characteristics (N=35) (N=30) value
groups completed the demographic form as well as IDQoL-BCI question- N (%) N (%)
naire, while their blood samples were taken and sent to the hospital lab-
Marital status Single 3(8.6) 0(0) 0.12
oratory in order to measure HbA1c level. Patients in the control group Married 30(85.7) 30(100)
only received the conventional clinical care. In the PMR group, in addi- Widow/widower 2(5.7) 0(0)
tion to conventional clinical care, they practiced Jacobson’s PMR at Employment status Unemployed 0(0) 1(3.3) 0.92
home for 12 weeks. Furthermore, 12 weeks after study entry, the pa- Employed 9(25.7) 8(26.7)
Housewife 14(40) 12(40)
tients of both groups completed IDQoL-BCI questionnaire and their Retired 12(34.3) 9(30)
HbA1c levels were measured, again. Education level Primary 2(5.7) 4(13.3) 0.55
Junior School 9(25.7) 5(16.7)
High school 15(42.9) 11(36.7)
2.8. Statistical analysis Academic 9(25.7) 10(33.3)
Income status Upper class income 0(0) 1(3.7) 0.39
Middle class income 23(67.6) 20(74.1)
Data were analyzed by the Statistical Package for the Social Sciences
Lower class income 11(32.4) 6(22.2)
(SPSS; SPSS Inc., Chicago, IL, USA) version 16.0. The quantitative and Regular physical Yes 17(48.6) 17(56.7) 0.51
qualitative variables were compared between two groups before (at activity
baseline) and 12 weeks after study entry using independent t-test as Underlying Diseases Hyperlipidemia 16(45.7) 19(63.3) 0.15
well as Chi-square and Fisher's exact tests, respectively. A paired t-test Hypertension 11(31.4) 9(30) 0.90
Liver disease 4(11.4) 0(0) 0.11
was also used to compare the quantitative data within groups before Duration of diabetes§ 6.58 ± 9.5 ± 0.02*
and after the intervention. Linear regression analysis was applied to in- 4.26 5.54
vestigate the effects of intervention on the outcome variables (HbA1c Adherence to diabetic Yes 6(17.1) 9(30) 0.49
level and HRQoL scores) after adjusting for confounders (duration of diet Somehow 28(80) 20(66.7)
No 1(2.9) 1(3.3)
type 2 DM and use of glibenclamide). The significance was attributed
Antidiabetic drugs Glibenclamid 9(25.7) 18(60) 0.005*
at p ≤ 0.05. Metformin 34(97.1) 29(96.7) 1
Acarbose 3(8.6) 4(13.3) 0.69
Ziptin 1(2.9) 2(6.7) 0.59
3. Results Gliclazide 5(14.3) 2(6.7) 0.43
Glitazone 1(2.9) 1(3.3) 1
Repaglinide 0(0) 3(10) 0.09
3.1. Demographic characteristics
BMI Low weightb18.5 0(0) 0(0) 0.69
Normal 7(20) 11(36.7)
In Table 1, the demographic variables were compared between two weight=18.5-24.9
groups. The mean age (SD) of patients in the control group was 54.08 Overweight=25-29.9 17(48.6) 9(30)
(6.06) in the range of 39-65, while the mean age (SD) of patients in Obese ≥ 30 11(31.4) 10(33.3)

the PMR group was 54.56 (5.65) in the range of 43-65. Mean disease du-
ration (SD) for the control group was 6.58 (4.26) in the range of 1-20 and
for the PMR group was 5.54 (9.5) in the range of 2-23. There were no
significant differences regarding demographic and clinical characteris-
tics between two groups. However, there were statistically significant
differences in terms of the use of glibenclamide (P =0.005) and disease
duration (P =0.021) between the PMR and control groups. The effects
of disease duration and use of glibenclamide on HbA1c levels and
IDQoL-BCI scores were measured separately using linear regression
analysis, and the results showed that there were no statistically signifi-
cant differences in this regards, suggesting these two variables had no
effect on the outcomes of this study (Table 2). According to the findings,
mean (SD) frequency of performing PMR was 1.73 (0.39) times per day.
§
; Data are presented as mean± standard deviation (SD), BMI; Body mass index, *;
Significant.
3.3. Health related quality of life (HRQoL) as a secondary outcome
The results of independent t-test showed that there was no statisti-
cally significant difference regarding the mean scores of HRQoL be-
tween the PMR and control groups before the intervention (Table 3).
There was a statistically significant difference in terms of psychosocial
dimension between groups at baseline, indicating that the PMR group
obtained higher scores as compared to the control group (P = 0.027).

Table 2
3.2. Glycosylated hemoglobin (HbA1c) as a primary outcome Comparison of the outcomes (HbA1c level and HRQoL scores) between the two groups be-
fore and after the intervention after adjusting for disease duration and use of
glibenclamide.
The results of independent t-test showed that there was a statistical-
ly significant difference regarding the mean HbA1c level (P=0.04) be- Model Unstandardized Standardized t P
tween the patients with type 2 DM in the PMR and control groups coefficients coefficients value
before the intervention (Table 3). However, there was no significant dif- B Std. Beta
ference regarding the mean HbA1c level between the experimental and error
control groups 12 weeks after the study entry. Furthermore, there was Primary outcome: HbA1c level
no statistically significant difference in terms of mean changes of Constant 0.008 0.297 0.029 0.977
HbA1c level between groups before and after the intervention. Accord- Duration of type 2 DM 0.032 0.035 0.129 0.930 0.356
Glibenclamid 0.257 0.354 0.101 0.727 0.470
ing to the Table 3, the result of paired t-test showed that in the PMR
Secondary outcome: HRQoL score
group, there was a statistically significant decrease in mean HbA1c Constant 1.379 1.638 0.842 0.403
level after the intervention as compared to the baseline (t = 2.153, Duration of type 2 DM 0.080 0.191 0.059 0.417 0.678
P=0.04). However, in the control group, there was no significant differ- Glibenclamid 0.680 1.954 0.049 0.348 0.729
ence regarding the mean HbA1c level before and 12 weeks after the HbA1c; Glycated hemoglobin, HRQoL; Health Related Quality of Life, Std.; Standard, DM;
study entry (t=1.22, P=0.230). diabetes mellitus.
146 T. Najafi Ghezeljeh et al. / Applied Nursing Research 33 (2017) 142–148

Table 3
Comparison of HRQoL score (total and its dimensions) and mean levels of HbA1c between two groups before and after intervention.

Groups Control PMR Independent t-test result P value

(N=35) (N=30)

Variables Mean±SD§ Mean±SD§

HbA1c Before 7.62±1.37 8.41 ±1.65 -2.10 0.04*

After 7.35±1.34 7.39 ±1.35 -1.72 0.09
Paired t-test result 1.22 2.15
P value 0.23 0.04*
Total HRQoL Before 34.43±7.50 36.56±8.17 -1.09 0.27
After 33.02±6.40 33.27±6.53 -1.11 0.27
Paired t-test result 1.71 2.10
P value 0.09 0.04*
Complication of diabetes Before 13.30±3.36 13.66±6.24 - 0.29 0.77
After 13.02±3.36 11.81± 2.70 1.57 0.12
Paired t-test result 1.38 1.58
P value 0.177 0.123
Diagnosis, treatment and follow-up factors Before 9.91± 3.31 10.08 ± 2.77 - 0.22 0.82
After 9.08 ± 3.28 10.10 ± 3.30 - 1.23 0.22
Paired t-test result 1.79 - 0.02
P value 0.08 0.97
Psychosocial effect of diabetes Before 11.19 ± 2.94 12.80 ± 2.77 - 2.25 0.02*
After 10.95 ± 2.40 11.39 ± 2.39 - 0.72 0.46
Paired t-test result 0.49 2.49
P value 0.62 0.01*

*; Significant, SD; standard deviation, HbA1c; Glycated hemoglobin, HRQoL; Health Related Quality of Life.

In other dimensions of HRQoL, there was no significant difference be-
tween groups before the intervention. Furthermore, there were no sig-
nificant differences regarding mean scores of total HRQoL and any of its
dimensions between the two groups after the intervention (Table 3).
There were no statistically significant differences regarding mean
change scores of total HRQoL and any of its dimensions between groups
before and after 12 weeks. In addition, the result of paired t-test showed
a significant increase in the mean scores of total HRQoL (P=0.045) and
psychosocial dimension (P=0.019) in the PMR group before and after
intervention. There were no significant differences regarding other di-
mensions of HRQoL in the PMR group before and after intervention. In
the control group, there were no statistically significant differences re-
garding the mean scores of total HRQoL and any of its dimensions before
and after intervention.
4. Discussion
The current study showed that application of Jacobson's PMR for 12
weeks had no effects on HbA1c levels and HRQoL of patients with
type 2 DM as compared to the control group. Our findings also indicated
that patients of both groups had poor glucose control, especially PMR
group, before intervention, indicating there was a significant difference
between two groups in terms of HbA1c levels before intervention. Fur-
thermore, HbA1c levels of PMR group did not decrease after the inter-
vention as compared to the control group. However, within group
comparison showed a reduction in HbA1c level in the PMR group after
the intervention. Similar to the current study, in a quasi-experimental
study, a combination of relaxation and music presented in 10 sessions
for three months reduced FBS and systolic and diastolic blood pressure
(SBP and DBP) but had no effect on HbA1c and triglyceride (TG) levels
as compared to the control group. Furthermore, there were no signifi-
cant differences regarding FBS, HbA1c, TG and cholesterol levels in the
PMR group before and after the intervention (Khoshkhou et al., 2010).
However, in another study, the impact of stress management pro-
gram on patients with type 2 DM have been evaluated. The stress man-
agement program included diaphragmatic breathing exercises for 10
minutes and PMR for 15 minutes twice a day for 8 weeks. Their findings
have showed a significant decrease in stress scores and HbA1c levels in
experimental group as compared to the control group (Koloverou,
Tentolouris, Bakoula, Darviri, & Chrousos, 2014). The difference be-
tween their findings and the current study can be related to the
synergistic effects of combination of two relaxation methods that result-
ed in reduction of stress and blood glucose levels. Furthermore, 9-11
sessions of CBT during 4 months were effective on adherence, depres-
sion and HbA1c levels of patients with type 2 DM (Safren et al., 2014).
The mixed of results of two studies can be attributed to the differences
in the nature of the interventions (integrated appraoch with more time-
intensive).
In expalnation of the current results, as the mechanism of relaxation
is reducing stress (Ditomasso, Golden, & Morris, 2010), after the appli-
cation of PMR, the patients of the PMR group with lower control of glu-
cose showed no reduction in HbA1c levels. It seems that it is necessary
to continue the procedure for the longer term to see the results. In this
regard, a study evaluated the effect of stress management in patients
with type 2 DM in 2, 4, 6 and 12 months after the intervention. Their re-
sults showed that 6 months after the intervention, significant reduction
in HbA1c levels were started as compared to the control group (Surwit
et al., 2002). However, high quality RCTs are necessary to indicate long
term effects of PMR on glycemic control.
Furthermore, some studies in different groups of people with diabe-
tes investigated the effect of cognitive behavioural interventions.
Penckofer et al. (2012) reported that in comparison with usual care,
psychoeducational experimental and group therapy was more effective
in reducing depression, anxiety and anger, but not effective in improv-
ing FBS and HgA1C. The results of some studies were not in line with
the current research which can be attributed to the methodological is-
sues and various nature of the interventions as well. Another study
has also demonstrated that relaxation reduced FBS and HbA1c levels
in children with type 1 DM as compared to the baseline, meaning that
the intervention was effective (Talakob, Jozi, Ghazavi, & Atari, 2005).
However, in this study, statistical analysis of both groups after the inter-
vention was not reported. In a study conducted in Sari, Iran, a significant
reduction in anger expression and HbA1c levels have been reported in
patients with types 1 and 2 DM using a Goldfried and Davison’s PMR
technique for three months. It has been indicated that Goldfried and
Davison’s PMR technique was more effective than Jacobson's PMR tech-
nique in patients with DM (Asadi et al., 2013). In the recent study, in ad-
dition to training of relaxation method, there was educational courses
about DM and its relationship with stress; however, it is unclear that
significant reduction in anger expression and HbA1c levels were
under which interventions (PMR or educational courses). Similarly, a
study has demonstrated that the combination of educational courses
 T. Najafi Ghezeljeh et al. / Applied Nursing Research 33 (2017) 142–148
and PMR technique improved HRQoL, functional impairment and symp-
toms in patients with acute schizophrenia as compared to the applica-
tion of a single method (Wang, Luo, Kan, & Wang, 2015).
Our findings showed that the mean scores of HRQoL in all partici-
pants were in middle range before the intervention. This result was con-
sistent with a study on QoL in patients with diabetes, living in Tehran,
Iran (Darvishpoor kakhki & Abed Saeedi, 2013). In the current study,
there was no significant difference in the total HRQoL and its dimen-
sions after intervention in the PMR group as compared to the control
group. However, our findings indicated that after the intervention,
there was a significant improvement in the total HRQoL and its psycho-
social dimension in the PMR group as compared to the baseline. Similar-
ly, in a quasi-experimental study (with no control group) on the effects
of massage and PMR on HRQoL of patients with type 2 DM, it has been
illustrated that both massage and PMR did not improve HRQoL as com-
pared to the baseline, suggesting there was no statistically significant
differences regarding HRQoL between groups after the intervention
(Wandell et al., 2011). Another quasi-experimental study with pre-test/
post-test design has evaluated the effect of exercise and relaxation on
HRQoL in black women with type 2 DM living in South Africa. Although
the type of relaxation technique was not specified, the results have
showed that in within group comparison, both relaxation and exercise
were improved HRQoL, whereas there was no difference between two
groups in terms of HRQoL (Van Rooijen et al., 2004). Their results are
consistent with our findings; however, they did not have a control
group.
In addition, Welschen et al. (2013) indicated that physical activity,
quality of life and depression improved among patients with type 2
DM in the CBT group after 6 months, and disappeared after 12 months.
However, Masoudi et al. (2011) have reported that there was a signifi-
cant improvement in HRQoL among patients with multiple sclerosis in
the PMR group as compared to the control group. The variation between
their results and the current study may be attributed to the differences
in study population and type of relaxation techniques, although the type
of relaxation technique was not specified in their study.
Therefore, it can be stated that PMR, including Jacobson's, is consid-
ered as a stress-relieving method in which a patient learns to tighten
and relax the muscles on a regular basis and after muscles are complete-
ly relaxed, stress is reduced (Ditomasso et al., 2010). The HRQoL as a
multidimensional concept focuses on physical, social and spiritual
well-being (Fairclough, 2010). Our results illustrated that PMR failed
to improve total HRQol and its related dimensions only by reducing
stress, whereas within group comparison showed improvement in
total HRQol and its psychosocial dimension in patients of PMR group.
However, in the current study, the stress level of patients was not eval-
uated. It is noted that DM causes long-term chronic stress due to the na-
ture of disease, its causes, and its treatment process, whereas PMR has a
short-term effect. In another word, PMR may show positive effects on
HbA1c level and HRQOL in patients with DM type 2 when using the
technique for a long period of time. Therefore, similar studies to deter-
mine long-term effects of PMR on HbA1c and HRQoL in patients with
type 2 DM and compare between patients with different levels of stress
is recommended.
In addition, in the current study, the absence of intervention ef-
fect on HRQoL may be associated with less frequent applications of
PMR during a day. In a study, after 12 weeks of PMR, anxiety, depres-
sion and HRQoL of patients with endometriosis significantly im-
proved as compared to the control group (Zhao et al., 2012). The
type of PMR was not specified by them. The differences may be at-
tributed to the population of study and frequency of applying tech-
nique in a day. In the current study, PMR was done 1.73 times per
day, whereas in the recent-mentioned study, the intervention was
done 3.2 times per day. Also the absence of intervention effect on
the studied variables can be associated with lack of sample size and
sample attrition. Therefore, conducting a similar study with a larger
sample size is suggested.
147
In our study, there are several limitations that may affect the results.
Firstly, due to the nature of the intervention, it was impossible for par-
ticipants to be blinded to the intervention used, so there is a possibility
of a Hawthorne effect. Secondly, the results of this study is likely to be
limited to patients who attend an outpatient clinic, use oral medication
for more than a year, have no major complications of DM and live in a
city.
5. Conclusion
In conclusion, the results of this study showed that Jacobson's PMR
technique neither reduced HbA1c level nor improved HRQoL in patients
with type 2 DM. Conducting further studies with eliminating the meth-
odological problems including low sample size, less frequency of inter-
vention per day and short follow-up time is suggested. In addition,
further studies are necessary to evaluate the impact of a combination
of Jacobson's PMR with other complimentary methods for patients
with type 2 DM to reduce HgA1c level and improve QoL.
Conflict of interest
There is no conflict of interest in this study.
Acknowledgment
This study was part of a research project which was granted by the
Center of Nursing and Midwifery Care Research of Iran University of
Medical Sciences and registered in the Iranian Registry of Clinical Trials
(Code No: IRCT2015021821134N1). The authors would like to thank
the Center for Nursing Care Research and the School of Nursing and
Midwifery of Iran University of Medical Sciences.
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