- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06867575
Effects of Progressive Relaxation Exercises
August 25, 2025 updated by: Necibe Dağcan, Kutahya Health Sciences University
Effects of Progressive Relaxation Exercises on Sleep Quality, Psychological Resilience and Quality of Life in Nursing Students: A Randomized Controlled Trial
When the literature is examined, it is observed that the effects of progressive relaxation exercises on pain, anxiety and sleep quality have been frequently investigated in different populations.
Studies conducted with nursing students focus on dysmonorrhea and clinical anxiety and stress .
A limited number of studies have focused on the quality of life of students .
There is no study examining the effects of progressive relaxation exercises on sleep quality, psychological endurance and quality of life together.
Therefore, the aim of our study is to examine the effects of progressive relaxation exercises applied to nursing students on sleep quality, psychological endurance and quality of life.
It is thought that our study results will contribute to the literature in terms of their originality.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This research is a randomized controlled trial planned to examine the effects of progressive relaxation exercises on sleep quality, psychological resilience and quality of life in nursing students.
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Kütahya, Turkey (Türkiye), 43000
- Necibe
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
Being a student in the Department of Nursing
- Being willing to participate in the study
- Not having a chronic disease that may prevent exercise (COPD, heart failure, etc.)
- Not having a hearing problem
- Not having a psychiatric diagnosis (major depression, anxiety disorders, etc.) and not using medication for anxiety or depression
- Having a computer and technological devices at home
- Being able to use a mobile phone (IOS-Android)
- Having internet access
- Being able to speak Turkish
- Not having used techniques such as meditation, hypnosis, yoga for the last 6 months before the study
- Not having a neurological, systemic, or psychiatric disease.
Exclusion Criteria:
• Nursing students who do not volunteer to participate in the study,
- Those who have any health problems during the application process,
- Those who cannot continue the study for any reason,
- Those who want to withdraw from the study with their own consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Progressive relaxation group
Progressive Relaxation Exercises
|
Progressive Relaxation Exercise Steps
|
|
No Intervention: Control group
The students who formed the control group and accepted to participate in the study will be asked to fill out the "Descriptive Characteristics Form", "Pittsburgh Sleep Quality Index (PSQI)", "Adult Resilience Scale", and "SF-36 Quality of Life Scale" in the first meeting.
After filling out the data collection tools in the first meeting in the classroom, no intervention will be made.
At the end of the 4th week follow-up period, separate data collection forms and post-test results will be obtained.
The control group will be given a progressive relaxation exercise audio recording and booklets with written instructions stated in the audio recording.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Average sleep quality score
Time Frame: First week, 4th week
|
Pittsburgh Sleep Quality Index: This scale is a 19-item self-report scale that evaluates sleep quality and disturbances in the past month.
The PSQI consists of 24 questions, 19 of which are answered by the participant, while 5 questions are answered by the spouse or roommate.
The scale is divided into 7 main components: Subjective Sleep Quality, Sleep Latency, Sleep Duration, Sleep Efficiency, Sleep Disturbances, Sleep Medication Use, and Daytime Dysfunction.
Each component is scored between 0 and 3, and these scores give a total result between 0 and 21.
A total score above 5 indicates poor sleep quality.
|
First week, 4th week
|
|
Average resilience scores for Adults
Time Frame: First week, 4th week
|
The scale containing a total of 33 items is in 5-point Likert type.
The scale consists of 6 sub-dimensions.
Of these, 'structural style' (3, 9, 15, 21) and 'perception of future' (2, 8, 14, 20) are measured with 4 items each; 'family harmony' (5, 11, 17, 23, 26, 32), 'self-perception' (1, 7, 13, 19, 28, 31) and 'social competence' (4, 10, 16, 22, 25, 29) are measured with 6 items each and 'social resources' (6, 12, 18, 24, 27, 30, 33) are measured with 7 items.
In the scale, positive and negative features are on separate sides in order not to cause biased evaluation.
Five separate boxes were created for the answers.
The scoring method was left free in evaluating the level of psychological resilience as low or high.
The validity and reliability Cronbach alpha coefficient of the scale was determined as 0.86 (1) by Basım and Çetin (2011), and 0.89 in this study.
Considering that psychological resilience increases as the scores increase, the scoring is done as 1-2-3-4-5 from left to right
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First week, 4th week
|
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Avarage Quality of Life scores
Time Frame: First week, 4th week
|
SF-36 Quality of Life Scale: The scale consists of 36 items and these provide the assessment of different health dimensions under 8 subscales: 1) Physical function (10 items) 2) Social function (2 items) 3) Role limitations due to physical problems (4 items) 4) Role limitations due to emotional problems (3 items) 5) Mental health (5 items) 6) Energy/vitality (4 items) 7) Pain (2 items) 8) General health perception (5 items) (Ware & Sherbourne, 1992).
The scale is assessed by considering the last 4 weeks.
A form evaluating the last 1 week was also applied in order to create the acute form.
The assessment is made in Likert type (three-point-six-point) except for items 4 and 5; items 4 and 13 and 5 are answered in a yes/no format.
Instead of giving a single total score, the scale gives a total score for each subscale separately.
The second question of the scale, 'Compared to last year, how do you evaluate your health now?' only includes one-year changes, but this question is not included
|
First week, 4th week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Necibe DAĞCAN ŞAHİN, PhD, Kütahya Health Sciences University, Faculty of Health Sciences
- Study Director: Burcu NAL, PhD, Kütahya Health Sciences University, Faculty of Health Sciences
- Study Director: Sema ÜSTÜNDAĞ, PhD (c), Kütahya Health Sciences University, Faculty of Health Sciences
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 25, 2025
Primary Completion (Actual)
February 25, 2025
Study Completion (Actual)
April 30, 2025
Study Registration Dates
First Submitted
February 25, 2025
First Submitted That Met QC Criteria
March 4, 2025
First Posted (Actual)
March 10, 2025
Study Record Updates
Last Update Posted (Estimated)
August 29, 2025
Last Update Submitted That Met QC Criteria
August 25, 2025
Last Verified
August 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KutahyaHSU-NECİBE-DAĞCAN-0004
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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