The Effect of Progressive Relaxation Exercises Applied to Individuals With Diabetes on Fatigue and Sleep
1 other identifier
interventional
63
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable diabetes-mellitus
Started Jan 2022
Shorter than P25 for not_applicable diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 20, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 20, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 20, 2022
CompletedFirst Submitted
Initial submission to the registry
May 30, 2023
CompletedFirst Posted
Study publicly available on registry
June 8, 2023
CompletedJune 8, 2023
May 1, 2023
2 months
May 30, 2023
May 30, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
Study Arms (2)
END
EXPERIMENTALUse of progressive relaxation exercises education
END free
NO INTERVENTIONpatient witout of progressive relaxation exercises education
Interventions
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.
Eligibility Criteria
You may qualify if:
- diagnosed with type 1 or type 2 diabetes
- using insulin
- had no disease that could prevent them from exercising.
You may not qualify if:
- Not having been diagnosed with diabetes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ankara Yıldırım Beyazıt University
Ankara, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doç.Dr
Study Record Dates
First Submitted
May 30, 2023
First Posted
June 8, 2023
Study Start
January 20, 2022
Primary Completion
March 20, 2022
Study Completion
May 20, 2022
Last Updated
June 8, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share