The Effect of Progressive Relaxation Exercises in University Students

March 29, 2023 updated by: Naile Bilgili, Gazi University

The Effect of Progressive Muscle Relaxation Exercise on Mental Health and Life in University Students: A Randomized Controlled Study

The aim of this randomized controlled study is to determine the effect of progressive muscle relaxation exercise on mental health and quality of life in university students. The research was carried out with the 1st and 2nd year students of Tokat Gaziosmanpaşa University Reşadiye Vocational School Health Care Services Department Elderly Care Program. The data of the study were collected using the Introductory Information Form, Brief Symptom Inventory, and Quality of Life Scale. University students in the intervention group were given progressive muscle relaxation exercise at least 4 times a week for 6 weeks.

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

The aim of this randomized controlled parallel group single-center study is to determine the effect of progressive muscle relaxation exercise on mental health and quality of life in university students. The research was conducted online with Tokat Gaziosmanpaşa University Reşadiye Vocational School Health Care Services Department Aged Care Program 1st and 2nd grade students. The research was carried out with a total of 86 students, 43 of which were in the intervention group and 43 in the control group. The data of the study were collected using the Introductory Information Form, Brief Symptom Inventory, SF-36, Progressive Muscle Relaxation Exercise Follow-up Form. University students in the intervention group were given progressive muscle relaxation exercise at least 4 times a week for 6 weeks. No intervention was made in the control group. University students in the control group were asked to continue their daily lives. Ethics committee permission, institutional permission, scale usage permission and written consent of the participants were obtained for the research.

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.
86

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

  • Turkey
    • Çankaya/Ankara
      • Ankara, Çankaya/Ankara, Turkey, 06490
        • Gazi University

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
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Volunteering to participate in the study
  • Being 18 years or older,
  • Having the necessary technology to participate in the study online (Smartphone, computer, etc.)

Exclusion Criteria:

  • Presence of any diagnosed musculoskeletal disease

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

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: Experimental: Progressive Muscle Relaxation Exercise
Participants performed muscle relaxation exercises at least 4 times a week for 6 weeks. Once a week, the researcher exercised with the participants in online groups to control the research and to check whether the participants were doing the exercise correctly.
Other: Progressive Muscle Relaxation Exercise
University students did progressive muscle relaxation exercises at least 4 times a week for 6 weeks. Once a week, exercise was done with the researcher by online interview via Zoom.
Other Names:
  • Progressive muscle relaxation exercise implementation, online interview
No Intervention: No Intervention: Control Group
The participants continued their daily life.

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
Brief Symptom Inventory
Time Frame: 6 weeks
Likert-type self-evaluation scale consisting of 53 items was developed to determine the mental state of individuals. Items were graded between 0-4 values corresponding to "not at all" and "too much". It consists of nine subscales, three global indexes and additional items. The 9 sub-dimensions of the scale were formed as somatization, obsessive-compulsive symptom, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid thought and psychotism, respectively. The scale can be applied to adolescent and adult individuals and groups. The high total scores obtained from the scale indicate the frequency of the individual's symptoms. The score range is between 0-212.
6 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The Mos 36 Item Short Form Health Survey (Sf-36)
Time Frame: 6 weeks
The Short Form 36 is a widely used scale in health-related quality of life research. In the evaluation of sub-dimensions; each dimension is scored between 0 and 100 points, and a high score indicates a good quality of life. The SF-36 quality of life scale consists of 8 health concepts. These are physical function, social function, role limitations due to physical problems, role limitations due to emotional problems, mental health, energy, pain and general perception of health. It consists of 36 items in total.
6 weeks

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.
Gazi University

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.
August 16, 2021

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.
September 27, 2021

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.
September 30, 2021

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).
March 29, 2023

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 29, 2023

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.
April 11, 2023

Study Record Updates

Last Update Posted (Actual)

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.
April 11, 2023

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.
March 29, 2023

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.
March 1, 2023

More Information

Terms related to this study

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.
  • 2021-807

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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