NCT05893784

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2022

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

May 30, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 8, 2023

Completed
Last Updated

June 8, 2023

Status Verified

May 1, 2023

Enrollment Period

2 months

First QC Date

May 30, 2023

Last Update Submit

May 30, 2023

Conditions

Keywords

Diabetes Mellitusnurseprogressive relaxation exercisesfatiguesleep

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

EXPERIMENTAL

Use of progressive relaxation exercises education

Other: Use of progressive relaxation exercises education

END free

NO INTERVENTION

patient 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.

END

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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)

Location

MeSH Terms

Conditions

Diabetes MellitusFatigue

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

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

Locations