Effects of Progressive Relaxation ExerciseNCT06522126
The Effects of Progressive Relaxation Exercise
A study testing progressive relaxation exercise in people with Effects of Progressive Relaxation Exercise and Exercise, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
Aim: This research was conducted to determine the effects of progressive relaxation exercise on life satisfaction, anxiety, and psychological well-being in people experiencing premenstrual syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Effects of Progressive Relaxation Exercise, Exercise, Relation, Interpersonal
- What is being tested?
- progressive relaxation exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2022to 2 May 2024
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Those who scored 111 points or more on the Premenstrual Syndrome Scale,
- were married or single at the time of the research,
- did not have children.
Who cannot join
- those who were pregnant or postpartum,
- those who were diagnosed with any psychiatric disease according to the records,
- those who did not perform relaxation exercises outside of the training.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Progressive Relaxation Exercise on Life Satisfaction, Anxiety, and Psychological Well-being in Students Experiencing Premenstrual Syndrome: A Randomized Controlled Trial
Aim: This research was conducted to determine the effects of progressive relaxation exercise on life satisfaction, anxiety, and psychological well-being in people experiencing premenstrual syndrome.
Methods: This randomized controlled trial was conducted with students who were enrolled in a university in the east of Türkiye, studying at the undergraduate levels outside the field of health, and experiencing premenstrual syndrome. The sample of the research consisted of 162 students (Exercise group 81 participants; Control group 81 participants). The Personal Information Form, Premenstrual Syndrome Scale (PMSS), Life Satisfaction Scale (LSS), Beck Anxiety Scale (BAS), and Psychological Well-Being Scale (PWBS) were used to collect data. Women in the exercise group underwent eight sessions of relaxation exercises, once a week for 8 weeks. In addition, for eight weeks after the first exercise, the participants exercised at home, at least twice a week, outside of the training. The PMSS, LSS, BAS, and PWBS were applied as post-tests to the participants in both groups, 8 weeks after the pre-tests.
- Being tested
- progressive relaxation exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
progressive relaxation exerciseBehavioural
One of the techniques employed to mitigate the prevalence of PMS complaints in women during this period is progressive relaxation exercises (PRE). It is one of the most preferred options due to its simplicity, cost-effectiveness, and reliability. Over the course of numerous years of research, progressive relaxation has been validated as an efficacious approach for regulating muscle tension. These exercises are performed to facilitate the distinction between tension and looseness in the body and to enable the individual to relax on her own in daily life. PRE involves the voluntary, systematic tension and relaxation of large muscle groups in the human body. PRE reduces anxiety levels by reducing muscle tension. It also provides the individual with a sense of profound rest, renewal, and rebirth.
| Study group | Role | What they receive |
|---|---|---|
| effects of progressive relaxation exercise | Experimental | Progressive relaxation exercises were given to female students who scored 111 and above on the PMS scale and were selected by randomization for the exercise group. The exercises were applied to those who participated in the study, met the inclusion criteria, and were able to participate in the study for 8 weeks. In the study, progressive relaxation exercises were applied by the researcher to the students in the exercise group with PMS complaints in the first three days of their first menstrual cycle. Receives: Behavioral: progressive relaxation exercise |
| control groups | No intervention | Control group standard care group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Premenstrual Syndrome Scale (PMSS)
It is a 44-item Likert-type scale developed by Gençdoğan (2006) that measures the severity of premenstrual symptoms. The scale has nine subscales, and the "PMSS total score" consisting of the scores related to the subscales and the total of the scale is obtained. The application of PMSS is done by retrospectively evaluating the person's status "one week before menstruation". The lowest score that can be obtained from the scale is 44 and the highest score is 220. The higher the score, the more intense the premenstrual syndrome symptoms are considered. The highest score that can be obtained for the total score is 220, 50% of which is 110 points. Therefore, those who score 111 and higher have PMS in terms of total score.
Measured: 8 weeks
Secondary outcomes (1)
Life Satisfaction Scale (LSS)
The scale was developed by Diener et al. Cronbach's alpha reliability coefficient of the scale was determined
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start1 Sep 2022
- Primary completion1 May 2024
- Study completion2 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effects of Progressive Relaxation ExerciseStudies of the same condition, open and under way.
- More trials run by Inonu 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra SABANCI BARANSEL, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06522126
- Sponsor's protocol ID
- 2022/3734
- Status last verified
- Aug 2024
- First submitted
- 22 Jul 2024
- Last updated
- 2 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data were not shared
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Progressive Relaxation Exercise on Life Satisfaction, Anxiety, and Psychological Well-being in Students Experiencing Premenstrual Syndrome: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06522126
- Acronym / sponsor ID
- 2022/3734
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 2 May 2024 (actual)
- First posted
- 26 Jul 2024 (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.
Aim: This research was conducted to determine the effects of progressive relaxation exercise on life satisfaction, anxiety, and psychological well-being in people experiencing premenstrual syndrome.
Methods: This randomized controlled trial was conducted with students who were enrolled in a university in the east of Türkiye, studying at the undergraduate levels outside the field of health, and experiencing premenstrual syndrome. The sample of the research consisted of 162 students (Exercise group 81 participants; Control group 81 participants). The Personal Information Form, Premenstrual Syndrome Scale (PMSS), Life Satisfaction Scale (LSS), Beck Anxiety Scale (BAS), and Psychological Well-Being Scale (PWBS) were used to collect data. Women in the exercise group underwent eight sessions of relaxation exercises, once a week for 8 weeks. In addition, for eight weeks after the first exercise, the participants exercised at home, at least twice a week, outside of the training. The PMSS, LSS, BAS, and PWBS were applied as post-tests to the participants in both groups, 8 weeks after the pre-tests.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| effects of progressive relaxation exercise | Experimental | Behavioral: progressive relaxation exerciseProgressive relaxation exercises were given to female students who scored 111 and above on the PMS scale and were selected by randomization for the exercise group. The exercises were applied to those who participated in the study, met the inclusion criteria, and were able to participate in the study for 8 weeks. In the study, progressive relaxation exercises were applied by the researcher to the students in the exercise group with PMS complaints in the first three days of their first menstrual cycle. |
| control groups | No intervention | –Control group standard care group |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Those who scored 111 points or more on the Premenstrual Syndrome Scale,
- were married or single at the time of the research,
- did not have children.
Key exclusion criteria (3 listed)
- those who were pregnant or postpartum,
- those who were diagnosed with any psychiatric disease according to the records,
- those who did not perform relaxation exercises outside of the training.
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 relaxation exerciseOne of the techniques employed to mitigate the prevalence of PMS complaints in women during this period is progressive relaxation exercises (PRE). It is one of the most preferred options due to its simplicity, cost-effectiveness, and reliability. Over the course of numerous years of research, progressive relaxation has been validated as an efficacious approach for regulating muscle tension. These exercises are performed to facilitate the distinction between tension and looseness in the body and to enable the individual to relax on her own in daily life. PRE involves the voluntary, systematic tension and relaxation of large muscle groups in the human body. PRE reduces anxiety levels by reducing muscle tension. It also provides the individual with a sense of profound rest, renewal, and rebirth. | Behavioural | effects of progressive relaxation exercise |
Primary outcome
Premenstrual Syndrome Scale (PMSS)
Time frame: 8 weeks
It is a 44-item Likert-type scale developed by Gençdoğan (2006) that measures the severity of premenstrual symptoms. The scale has nine subscales, and the "PMSS total score" consisting of the scores related to the subscales and the total of the scale is obtained. The application of PMSS is done by retrospectively evaluating the person's status "one week before menstruation". The lowest score that can be obtained from the scale is 44 and the highest score is 220. The higher the score, the more intense the premenstrual syndrome symptoms are considered. The highest score that can be obtained for the total score is 220, 50% of which is 110 points. Therefore, those who score 111 and higher have PMS in terms of total score.
1 secondary outcome
Life Satisfaction Scale (LSS)
Time frame: 8 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 2 Aug 2024.
- Individual participant dataSharing planned: No. No individual participant data were not shared
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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 relaxation exercise in people with Effects of Progressive Relaxation Exercise and Exercise, run by Inonu 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 3 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 2 Aug 2024. 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?
Premenstrual Syndrome Scale (PMSS) (time frame: 8 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 2 Aug 2024.