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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Progressive relaxation group
Progressive Relaxation Exercises
Other: Progressive Relaxation Exercise
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
First week, 4th week
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kutahya Health Sciences University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 25, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 25, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 25, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 10, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 29, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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