Progressive Muscle Relaxation ExerciseNCT05808829
The Effect of Progressive Relaxation Exercises in University Students
A study testing Progressive Muscle Relaxation Exercise in people with Progressive Muscle Relaxation Exercise, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Progressive Muscle Relaxation Exercise
- What is being tested?
- Progressive Muscle Relaxation Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Aug 2021to 30 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Volunteering to participate in the study
- Being 18 years or older,
- Having the necessary technology to participate in the study online (Smartphone, computer, etc.)
Who cannot join
- Presence of any diagnosed musculoskeletal disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Progressive Muscle Relaxation Exercise
- Being tested
- Progressive Muscle Relaxation Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive Muscle Relaxation ExerciseOther
Also called Progressive muscle relaxation exercise implementation, online interview
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Progressive Muscle Relaxation Exercise | Experimental | 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. Receives: Other: Progressive Muscle Relaxation Exercise |
| No Intervention: Control Group | No intervention | The participants continued their daily life. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief Symptom Inventory
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.
Measured: 6 weeks
Secondary outcomes (1)
The Mos 36 Item Short Form Health Survey (Sf-36)
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2023
- Study start16 Aug 2021
- Primary completion27 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Progressive Muscle Relaxation ExerciseStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naile Bilgili, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05808829
- Sponsor's protocol ID
- 2021-807
- Status last verified
- Mar 2023
- First submitted
- 29 Mar 2023
- Last updated
- 11 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Progressive Muscle Relaxation Exercise on Mental Health and Life in University Students: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05808829
- Acronym / sponsor ID
- 2021-807
- Conditions
- Progressive Muscle Relaxation Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 16 Aug 2021 (actual)
- Primary completion
- 27 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 11 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Progressive Muscle Relaxation Exercise | Experimental | Other: Progressive Muscle Relaxation ExerciseParticipants 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. |
| No Intervention: Control Group | No intervention | –The participants continued their daily life. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Volunteering to participate in the study
- Being 18 years or older,
- Having the necessary technology to participate in the study online (Smartphone, computer, etc.)
Key exclusion criteria (1 listed)
- Presence of any diagnosed musculoskeletal disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Progressive Muscle Relaxation ExerciseAlso: Progressive muscle relaxation exercise implementation, online interviewUniversity 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 | Experimental: Progressive Muscle Relaxation Exercise |
Primary outcome
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.
1 secondary outcome
The Mos 36 Item Short Form Health Survey (Sf-36)
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive Muscle Relaxation Exercise in people with Progressive Muscle Relaxation Exercise, run by Gazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Symptom Inventory (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2023.