The Effect of Progressive Relaxation Exercises Applied to Individuals With Diabetes on Fatigue and Sleep

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Other: Use of progressive relaxation exercises education

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey
    • Ankara Yıldırım Beyazıt University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• diagnosed with type 1 or type 2 diabetes
• using insulin
• had no disease that could prevent them from exercising.

Exclusion Criteria:

• Not having been diagnosed with diabetes

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: END; Use of progressive relaxation exercises education	Other: Use of progressive relaxation exercises education; Progressive relaxation exercises education It starts with deep breathing exercises along with music. Then stretching and relaxation exercises are performed. After the education, 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.
No Intervention: END free; patient witout of progressive relaxation exercises education

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Identification Form	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.	a day before the education
Pittsburgh Sleep Quality Index	Pittsburgh Sleep Quality Index 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".	a day before the education
Fatigue Severity Scale	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.	a day before the education

Collaborators and Investigators

• Sponsor: Ankara Yildirim Beyazıt University

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2022
• Primary Completion (Actual): March 20, 2022
• Study Completion (Actual): May 20, 2022

Study Registration Dates

• First Submitted: May 30, 2023
• First Submitted That Met QC Criteria: May 30, 2023
• First Posted (Actual): June 8, 2023

Study Record Updates

• Last Update Posted (Actual): June 8, 2023
• Last Update Submitted That Met QC Criteria: May 30, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: fatigue; sleep; Diabetes Mellitus; nurse; progressive relaxation exercises
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Fatigue
• Other Study ID Numbers: AnkaraYBU1324356

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No