Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05893784 |
| Other study ID # |
AnkaraYBU1324356 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 20, 2022 |
| Est. completion date |
May 20, 2022 |
Study information
| Verified date |
May 2023 |
| Source |
Ankara Yildirim Beyazit University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The aim of this study was to examine the effect of the progressive relaxation exercises
applied to the individuals with diabetes on fatigue and sleep. This randomized controlled
study was a single-blind, parallel intervention and control group experimental study. The
researcher applied the training for the progressive relaxation exercises to the intervention
group. Socio-demographic data, 'Pittsburgh Sleep Quality Index' and 'The Fatigue Severity
Scale' were used for the study.
Description:
The study was conducted on patients who applied to the endocrine polyclinic of a hospital in
Turkey and voluntarily agreed to participate in the study. The patients were diagnosed with
type 1 or type 2 diabetes, were over 18 years old and were using insulin. The patients were
able to communicate and had no disease that could prevent them from exercising.
The Intervention (n=33) and control groups (n=30) were formed by simple randomization method.
Data was collected by using "Patient Identification Form", "Pittsburgh Sleep Quality Index"
and "The Fatigue Severity Scale".
Patient Identification Form was created by scanning the literature for this study. In this
form, there were 10 questions in total. The questions included the first letters of the name
and surname of the patient for coding purposes. The other questions were about age, marital
status, employment status, educational status, drinking and smoking habbits, participation in
exercise training, exercise and sleep patterns.
Pittsburgh Sleep Quality Index was developed by Buysse et al. in 1989. It was adapted into
Turkish by Ağargün et al. in 1996 as PUKI. PUKI was a 24-item scale and it was used to
evaluate sleep quality and disturbance of the previous month. 19 of the questions were
self-report questions and those were answered by the patient. The question number 19 was
about the availability of a roommate or spouse and it was not used in scoring. The remaining
5 questions of 24 were to be answered by a spouse or a roommate, they were also not included
in the scoring. The 18 scored questions of the scale consisted of 7 components which were
Subjective Sleep Quality, Sleep Latency, Sleep Duration, Habitual Sleep Efficiency, Sleep
Disorder, Sleeping Drug Use, and Daytime Dysfunction. Each component was evaluated with a
score between 0 and 3 points. The total score of the 7 components was accepted as the score
of the scale. Therefore the total score of the scale was between 0 and 21 points. A total
score greater than 5 was accepted to be "poor sleep quality". The Cronbach Alpha internal
consistency coefficient of the scale was found to be 0.80.
Fatigue Severity Scale was developed by Krupp in 1989. It was adapted into Turkish by Armutlu
et al. in 2007. The Fatigue Severity Scale was cited as the best example among
one-dimensional scales. This scale consisted of 9 questions in total and the person indicated
how much he or she agreed with each question by choosing a value between 1 and 7 where 1
means I totally disagreed and 7 means I totally agreed. The score range of the scale was
between 9 and 63 points. A score of 36 or higher indicated severe fatigue. The total score
was calculated by taking the average of 9 answers. The cut-off value for pathological fatigue
was determined as 4 and above. The lower the total score, the less fatigue. Cronbach's alpha
reliability coefficient of the SSS is 0.96.
Progressive relaxation exercises training and questionnaires were administered to the
experimental group face-to-face in the endocrine polyclinic examination room by the
researcher, and each interview lasted approximately 30 minutes.
Written consent was obtained from the participants before the research. After explaining the
benefits, application steps, frequency and duration of progressive relaxation exercises,
practical exercise training was given by the researcher.
After the training, an 8-minute video in which the progressive relaxation exercises was
explained practically to the individuals was sent to their mobile phones. The participants
were asked to perform these exercises regularly for 4 weeks, each day one hour before going
to bed, simultaneously with the video.
The aforementioned video included breathing exercises and progressive muscle stretching
exercises, with music in the background to relax the patient. After 4 weeks, when the
individuals in the experimental group came to the endocrine polyclinic for control,
Pittsburgh Sleep Quality Index and The Fatigue Severity Scale were applied again by the
researcher as a post-test. No training was given to the control group by the researcher
during the study.
