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

Primary Purpose

Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Use of progressive relaxation exercises education
Sponsored by
Ankara Yildirim Beyazıt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes Mellitus focused on measuring Diabetes Mellitus, nurse, progressive relaxation exercises, fatigue, sleep

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Ankara Yıldırım Beyazıt University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

END

END free

Arm Description

Use of progressive relaxation exercises education

patient witout of progressive relaxation exercises education

Outcomes

Primary Outcome Measures

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.
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".
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.

Secondary Outcome Measures

Full Information

First Posted
May 30, 2023
Last Updated
May 30, 2023
Sponsor
Ankara Yildirim Beyazıt University
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1. Study Identification

Unique Protocol Identification Number
NCT05893784
Brief Title
The Effect of Progressive Relaxation Exercises Applied to Individuals With Diabetes on Fatigue and Sleep
Official Title
The Effect of Progressive Relaxation Exercises Applied to Individuals With Diabetes on Fatigue and Sleep
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
January 20, 2022 (Actual)
Primary Completion Date
March 20, 2022 (Actual)
Study Completion Date
May 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara Yildirim Beyazıt University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus
Keywords
Diabetes Mellitus, nurse, progressive relaxation exercises, fatigue, sleep

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
END
Arm Type
Experimental
Arm Description
Use of progressive relaxation exercises education
Arm Title
END free
Arm Type
No Intervention
Arm Description
patient witout of progressive relaxation exercises education
Intervention Type
Other
Intervention Name(s)
Use of progressive relaxation exercises education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patient Identification Form
Description
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.
Time Frame
a day before the education
Title
Pittsburgh Sleep Quality Index
Description
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".
Time Frame
a day before the education
Title
Fatigue Severity Scale
Description
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.
Time Frame
a day before the education

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Ankara Yıldırım Beyazıt University
City
Ankara
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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

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