Premenstrual SyndromeNCT05428800
The Effect of Progressive Relaxation Exercises on Premenstrual Syndrome Symptoms
A study testing Progressive Relaxation Exercises in people with Premenstrual Syndrome, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study; to determine the effect of progressive relaxation exercises on premenstrual syndrome symptoms. The study is a randomized controlled trial, and women between the ages of 18-35 who meet the inclusion criteria will be included. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Premenstrual Syndrome
- What is being tested?
- Progressive Relaxation Exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2022to 30 Dec 2022
- 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 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Being between 18-35 years old, single marital status,
- Willingness and volunteering to work,
- Being able to read and write in Turkish and understand what he reads,
- Applying to the obstetrics and gynecology outpatient clinic for routine control,
- Getting a score of 110 and above in PMSS.
Who cannot join
- The woman has an obstetric or medical health problem that prevents her from doing progressive relaxation exercises,
- Having a chronic and gynecological health problem,
- Regular exercise,
- There is a change in menstrual characteristics in the last six months.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kütahya Health Science University
Kütahya, 43000
About this study
Official title: The Effect of Progressive Relaxation Exercises on Premenstrual Syndrome Symptoms: Randomized Controlled Study
The aim of this study; to determine the effect of progressive relaxation exercises on premenstrual syndrome symptoms. The study is a randomized controlled trial, and women between the ages of 18-35 who meet the inclusion criteria will be included. Participant information form and premenstrual syndrome scale will be used in the research. There are two groups in the study as experimental (n=40) and control (n=40).
Read the detailed description
Institutional permission and ethics committee approval were obtained for the research. The population of the study consisted of 218 women. The sample of the study consisted of 80 women, 40 of which were experimental and 40 control. Participants were evaluated according to the www.randomizer.org program and randomization was achieved among the women participating in the study.
The research process and the participants in the experimental and control groups will be explained again and the necessary equipment will be provided by the researchers. The "Progressive Relaxation Exercises Guide" prepared by the researcher in accordance with the literature will be given to the women in the experimental group (40), taking the opinions and suggestions of eight experts. At the same time, the comprehensibility and applicability of the guide were evaluated by making a pilot application to 10 women before the research. Afterwards, all the information in the guide will be explained to the women in the experimental group and training will be given until adequate feedback is received. At the same time, progressive relaxation exercises belonging to the Turkish Psychological Association were given to the women in CD form, and listening to the audio recordings together with the relaxation exercises to be performed in accordance with the guide will be indicated. These exercises will be performed by the women in the experimental group for 25-30 minutes a day, every day for 8 weeks. At the end of 8 weeks, women will be reassessed with PMSS. The women in the control group (40) will be told to continue their routine habits regarding PMS in parallel with the study group, without any application. At the end of 8 weeks, women in the control group will be re-evaluated with PMSS.
- Conditions
- Premenstrual Syndrome
- Being tested
- Progressive Relaxation Exercises
- Keywords
- Premenstrual Syndrome, Exercises, Women Health
- Medical subject headings
- Premenstrual Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive Relaxation ExercisesBehavioural
Progressive muscle relaxation (PMR) is a relaxation technique that tenses and relaxes muscles in an unprompted, regular, and consecutive manner until the whole body is relaxed.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Progressive relaxation exercises will be performed for 25-30 minutes every day for 8 weeks, and at the end of 8 weeks, the group will be evaluated again with PMSS. Receives: Behavioral: Progressive Relaxation Exercises |
| Control | No intervention | They will continue their routine coping habits for 8 weeks, and at the end of 8 weeks, the group will be evaluated again with PMSS. |
What is being measured
The primary outcome is the main question the study is designed to answer.
intervention applied to the experimental group
At the end of 8 weeks of progressive relaxation exercises, improvement in premenstrual syndrome symptoms of the experimental group is expected.
Measured: It includes an 8-week process.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2022
- Study start15 Mar 2022
- Primary completion30 Jul 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premenstrual SyndromeStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled study
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif TUGCE CITIL, Kutahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05428800
- Sponsor's protocol ID
- E-41997688-050.99-43313
- Status last verified
- Feb 2023
- First submitted
- 9 Jun 2022
- Last updated
- 13 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Progressive Relaxation Exercises on Premenstrual Syndrome Symptoms: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05428800
- Acronym / sponsor ID
- E-41997688-050.99-43313
- Conditions
- Premenstrual Syndrome
- Keywords
- Premenstrual Syndrome, Exercises, Women Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 23 Jun 2022 (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 study; to determine the effect of progressive relaxation exercises on premenstrual syndrome symptoms. The study is a randomized controlled trial, and women between the ages of 18-35 who meet the inclusion criteria will be included. Participant information form and premenstrual syndrome scale will be used in the research. There are two groups in the study as experimental (n=40) and control (n=40).
Detailed description
Institutional permission and ethics committee approval were obtained for the research. The population of the study consisted of 218 women. The sample of the study consisted of 80 women, 40 of which were experimental and 40 control. Participants were evaluated according to the www.randomizer.org program and randomization was achieved among the women participating in the study.
The research process and the participants in the experimental and control groups will be explained again and the necessary equipment will be provided by the researchers. The "Progressive Relaxation Exercises Guide" prepared by the researcher in accordance with the literature will be given to the women in the experimental group (40), taking the opinions and suggestions of eight experts. At the same time, the comprehensibility and applicability of the guide were evaluated by making a pilot application to 10 women before the research. Afterwards, all the information in the guide will be explained to the women in the experimental group and training will be given until adequate feedback is received. At the same time, progressive relaxation exercises belonging to the Turkish Psychological Association were given to the women in CD form, and listening to the audio recordings together with the relaxation exercises to be performed in accordance with the guide will be indicated. These exercises will be performed by the women in the experimental group for 25-30 minutes a day, every day for 8 weeks. At the end of 8 weeks, women will be reassessed with PMSS. The women in the control group (40) will be told to continue their routine habits regarding PMS in parallel with the study group, without any application. At the end of 8 weeks, women in the control group will be re-evaluated with PMSS.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: Progressive Relaxation ExercisesProgressive relaxation exercises will be performed for 25-30 minutes every day for 8 weeks, and at the end of 8 weeks, the group will be evaluated again with PMSS. |
| Control | No intervention | –They will continue their routine coping habits for 8 weeks, and at the end of 8 weeks, the group will be evaluated again with PMSS. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Being between 18-35 years old, single marital status,
- Willingness and volunteering to work,
- Being able to read and write in Turkish and understand what he reads,
- Applying to the obstetrics and gynecology outpatient clinic for routine control,
- Getting a score of 110 and above in PMSS.
Key exclusion criteria (4 listed)
- The woman has an obstetric or medical health problem that prevents her from doing progressive relaxation exercises,
- Having a chronic and gynecological health problem,
- Regular exercise,
- There is a change in menstrual characteristics in the last six months.
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 ExercisesProgressive muscle relaxation (PMR) is a relaxation technique that tenses and relaxes muscles in an unprompted, regular, and consecutive manner until the whole body is relaxed. | Behavioural | Experimental |
Primary outcome
intervention applied to the experimental group
Time frame: It includes an 8-week process.
At the end of 8 weeks of progressive relaxation exercises, improvement in premenstrual syndrome symptoms of the experimental group is expected.
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 13 Feb 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 Relaxation Exercises in people with Premenstrual Syndrome, run by Kutahya Health Sciences 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 5 inclusion and 4 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 13 Feb 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?
intervention applied to the experimental group (time frame: It includes an 8-week process.). 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 13 Feb 2023.