Premenstrual SyndromeNCT06370429
Effect of Online Exercises for Premenstrual Syndrome on Couple's Stress and Family Function
A study testing Progressive Relaxation Exercises, randomized pretest-posttest in people with Premenstrual Syndrome and Exercises, run by Suleyman Demirel University at 1 site in Turkey (Türkiye).
Trial summary
Universe of Research The universe of the research; It will consist of women and their spouses with premenstrual syndrome complaints who use social media. 3.6. Sample of the Research The number of samples of the study was composed of a total of 60 (Intervention = 30, Control = 30) participants. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Premenstrual Syndrome, Exercises, Stress Level
- What is being tested?
- Progressive Relaxation Exercises, randomized pretest-posttest
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2024to 30 Dec 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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Volunteering to participate in the study,
- Being married and living with his wife
- Being between the ages of 18-45,
- The woman's ability to use a mobile phone and/or computer to receive online (Zoom; vs) counseling and listen to exercises,
- The woman and her husband have a application or e-mail address that can use the googledocs application.
- The woman and her husband must be literate
Show all 19Show fewer
- The woman does not have a hearing problem that would prevent her from understanding the voice recording,
- Scoring 110 or above on the Premenstrual Syndrome Scale
- Having regular menstrual cycles for the last six months,
- Not having undergone bilateral oophorectomy or hysterectomy,
- Not having been diagnosed with polycystic ovary syndrome,
- Having no other medical disease in the last six months,
- Participant who does not use oral contraceptives,
- Without severe psychosomatic disorder,
- Not pregnant or breastfeeding,
- No history of cancer.
- Those who do not use medical drugs to reduce premenstrual syndrome
- Those who do not use herbal medicine to reduce premenstrual syndrome
- Do not practice exercise, yoga, etc. to reduce premenstrual syndrome.
Who cannot join
- He or his spouse fills out the research survey forms incompletely,
- Wanting to leave the research at any stage of the research,
- Not participating in the final test,
- Pregnancy occurs,
- Receiving breathing exercise consultancy from another consultant during the study period
- Those who do the relaxation exercises incorrectly according to the Content of the Progressive Relaxation Exercises CD,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Progressive Relaxation Exercises Performed Online by Women With Premenstrual Syndrome on the Stress Level and Family Functionality of Women and Their Spouses
Universe of Research The universe of the research; It will consist of women and their spouses with premenstrual syndrome complaints who use social media.
3.6. Sample of the Research The number of samples of the study was composed of a total of 60 (Intervention = 30, Control = 30) participants.
Read more
Criteria for inclusion in the study:
- Being married and living with his wife
- Being between the ages of 18-45,
- The woman's ability to use a mobile phone and/or computer to receive online
- The woman and her husband must be literate
- The woman does not have a hearing problem that would prevent her from understanding the voice recording, 9. Scoring 110 or above on the Premenstrual Syndrome Scale 10. Having regular menstrual cycles for the last six months, 13. Having no other medical disease in the last six months, 14. Participant who does not use oral contraceptives, 16. Not pregnant or breastfeeding, 17. No history of cancer. 18. Those who do not use medical drugs to reduce premenstrual syndrome 19. Those who do not use herbal medicine to reduce premenstrual syndrome 20. Do not practice exercise, yoga, etc. to reduce premenstrual syndrome.
Exclusion criteria from the study:
- He or his spouse fills out the research survey forms incompletely,
- Pregnancy occurs,
- Receiving breathing exercise consultancy from another consultant during the study period
Data Collection Method and Duration Descriptive Characteristics Data Form, Perceived Stress Scale (PSS) and Family Assessment Scale will be applied to the sampled women and their spouses. Data collection will continue until the calculated sample number is reached.
Read the detailed description
Type of research The research will be conducted as a randomized controlled intervention study to Examine the Effects of Progressive Relaxation Exercises Performed Online by Women with Premenstrual Syndrome on the Stress Level and Family Functionality of Women and Their Spouses.
Universe of Research The universe of the research; It will consist of women and their spouses with premenstrual syndrome complaints who use social media.
3.6. Sample of the Research The sample of the research will consist of women who meet the inclusion criteria. The number of samples was calculated by the researchers using the Power analysis Power 3.1 package program. The sample calculation was based on the study titled 'The Effect of Progressive Relaxation Exercises on Stress Level, Sleep Quality and Exercise Capacity in Young Adults' in the pre-pandemic period in Turkish culture. 80% power from the study of Oğuz et al (2019); By calculating the sample size at an effect size of 0.82 and an error level of 0.05, it was determined that 20 women each should be included in the intervention and control groups in the study. However, since spouses will also participate in the survey process, considering that there may be losses for women and their spouses, the number of participants in each group was increased by 50% and the sample of the study was composed of a total of 60 (Intervention = 30, Control = 30) participants.
Criteria for inclusion in the study:
- Volunteering to participate in the study, 2. Being married and living with his wife 3. Being between the ages of 18-45, 5. The woman's ability to use a mobile phone and/or computer to receive online (Zoom; social media) counseling and listen to exercises, 6. The woman and her husband have a social media., application or e-mail address.
- The woman and her husband must be literate 8. The woman does not have a hearing problem that would prevent her from understanding the voice recording, 9. Scoring 110 or above on the Premenstrual Syndrome Scale 10. Having regular menstrual cycles for the last six months, 11. Not having undergone bilateral oophorectomy or hysterectomy, 12. Not having been diagnosed with polycystic ovary syndrome, 13. Having no other medical disease in the last six months, 14. Participant who does not use oral contraceptives, 15. Without severe psychosomatic disorder, 16. Not pregnant or breastfeeding, 17. No history of cancer. 18. Those who do not use medical drugs to reduce premenstrual syndrome 19. Those who do not use herbal medicine to reduce premenstrual syndrome 20. Do not practice exercise, yoga, etc. to reduce premenstrual syndrome.
Exclusion criteria from the study:
- He or his spouse fills out the research survey forms incompletely,
- Wanting to leave the research at any stage of the research,
- Not participating in the final test,
- Pregnancy occurs,
- Receiving breathing exercise consultancy from another consultant during the study period
- Those who do the relaxation exercises incorrectly according to the Content of the Progressive Relaxation Exercises,
Data Collection Method and Duration Descriptive Characteristics Data Form, Perceived Stress Scale (PSS) and Family Assessment Scale will be applied to the sampled women and their spouses. Data collection will continue until the calculated sample number is reached.
Hypotheses:
H1: There is a difference between the mean stress level scores of women with premenstrual syndrome who take online progressive relaxation exercises and women who do not.
H2: There is a difference between the mean stress level scores of women with premenstrual syndrome who receive online progressive relaxation exercises and the spouses of women who do not.
H3: There is a difference between the mean family functionality score of women with premenstrual syndrome who receive online progressive relaxation exercises and those who do not.
H4: There is a difference between the mean family functionality scores of women with premenstrual syndrome who receive online progressive relaxation exercises and their spouses who do not.
- Conditions
- Premenstrual Syndrome, Exercises, Stress Level, Family Characteristics
- Being tested
- Progressive Relaxation Exercises, randomized pretest-posttest
- Keywords
- Premenstrual Syndrome, Progressive Relaxation, Stress Level, Family Functionality
- 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 Exercises, randomized pretest-posttestOther
experimental and control ,a randomized pretest-posttest study to examine
| Study group | Role | What they receive |
|---|---|---|
| Progressive Relaxation Exercises | Experimental | Progressive Relaxation Exercises, randomized pretest-posttest Receives: Other: Progressive Relaxation Exercises, randomized pretest-posttest |
| control | No intervention | Non-intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Premenstrual Syndrome Scale
It is a 44-item, five-point Likert-type scale (Never, Very little, Sometimes, Frequently, Continuously) developed by Gencdogan and measures the severity of premenstrual symptoms.
In scoring the scale, the "Never" option is evaluated as 1 point, the "Very little" option is evaluated as 2 points, the "Sometimes" option is evaluated as 3 points, the "Often" option is evaluated as 4 points and the "Always" option is evaluated as 5 points.
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.
Measured: The research period for a participant takes approximately 3 months.
Family Assessment Scale
Its original form was developed by Brown University and Butler Hospital in the United States within the framework of the Family Research Program. The family evaluation scale consists of 60 (sixty) questions and 7 sub-dimensions. It is a scale with four options and each item is scored between 1.00 (healthy) and 4.00 (unhealthy). Minimum 60 and maximum 240 points are taken from the scale. As the score increases, it indicates that family functionality is not good.
Measured: The research period for a participant takes approximately four months.
Perceived Stress Scale
Perceived Stress Scale (PSS) Cohen consists of 14 items in total. The scale is a five-point Likert type in which each item is scored between "Never (0)" and "Very often (4)". The total score obtained from the scale ranges from 0 to 56, and the score obtained from 11 to 26 is considered low; 27-41 is medium; 42-56 indicates high stress level.
Measured: The research period for a participant takes approximately four months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start15 May 2024 (estimated)
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
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.
- 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
- The sample was divided into intervention and control groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suleyman Demirel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşe Sevim AKBAY KISA, Suleyman Demirel University
- Investigators
- Tuba NU KORKMAZ ASLAN, Study chair, Necmettin Erbakan UniversityGazi ÇU Kısa, Study chair, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06370429
- Sponsor's protocol ID
- 8743432956-050.99-621064
- Status last verified
- May 2024
- First submitted
- 12 Apr 2024
- Last updated
- 6 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Progressive Relaxation Exercises Performed Online by Women With Premenstrual Syndrome on the Stress Level and Family Functionality of Women and Their Spouses
- ClinicalTrials.gov ID
- NCT06370429
- Acronym / sponsor ID
- 8743432956-050.99-621064
- Conditions
- Premenstrual Syndrome, Exercises, Stress Level, Family Characteristics
- Keywords
- Premenstrual Syndrome, Progressive Relaxation, Stress Level, Family Functionality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Suleyman Demirel UniversityUniversity, hospital or other
- Study start
- 15 May 2024 (estimated)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 17 Apr 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.
Universe of Research The universe of the research; It will consist of women and their spouses with premenstrual syndrome complaints who use social media.
3.6. Sample of the Research The number of samples of the study was composed of a total of 60 (Intervention = 30, Control = 30) participants.
Criteria for inclusion in the study:
- Being married and living with his wife
- Being between the ages of 18-45,
- The woman's ability to use a mobile phone and/or computer to receive online
- The woman and her husband must be literate
- The woman does not have a hearing problem that would prevent her from understanding the voice recording, 9. Scoring 110 or above on the Premenstrual Syndrome Scale 10. Having regular menstrual cycles for the last six months, 13. Having no other medical disease in the last six months, 14. Participant who does not use oral contraceptives, 16. Not pregnant or breastfeeding, 17. No history of cancer. 18. Those who do not use medical drugs to reduce premenstrual syndrome 19. Those who do not use herbal medicine to reduce premenstrual syndrome 20. Do not practice exercise, yoga, etc. to reduce premenstrual syndrome.
Exclusion criteria from the study:
- He or his spouse fills out the research survey forms incompletely,
- Pregnancy occurs,
- Receiving breathing exercise consultancy from another consultant during the study period
Data Collection Method and Duration Descriptive Characteristics Data Form, Perceived Stress Scale (PSS) and Family Assessment Scale will be applied to the sampled women and their spouses. Data collection will continue until the calculated sample number is reached.
Detailed description
Type of research The research will be conducted as a randomized controlled intervention study to Examine the Effects of Progressive Relaxation Exercises Performed Online by Women with Premenstrual Syndrome on the Stress Level and Family Functionality of Women and Their Spouses.
Universe of Research The universe of the research; It will consist of women and their spouses with premenstrual syndrome complaints who use social media.
3.6. Sample of the Research The sample of the research will consist of women who meet the inclusion criteria. The number of samples was calculated by the researchers using the Power analysis Power 3.1 package program. The sample calculation was based on the study titled 'The Effect of Progressive Relaxation Exercises on Stress Level, Sleep Quality and Exercise Capacity in Young Adults' in the pre-pandemic period in Turkish culture. 80% power from the study of Oğuz et al (2019); By calculating the sample size at an effect size of 0.82 and an error level of 0.05, it was determined that 20 women each should be included in the intervention and control groups in the study. However, since spouses will also participate in the survey process, considering that there may be losses for women and their spouses, the number of participants in each group was increased by 50% and the sample of the study was composed of a total of 60 (Intervention = 30, Control = 30) participants.
Criteria for inclusion in the study:
- Volunteering to participate in the study, 2. Being married and living with his wife 3. Being between the ages of 18-45, 5. The woman's ability to use a mobile phone and/or computer to receive online (Zoom; social media) counseling and listen to exercises, 6. The woman and her husband have a social media., application or e-mail address.
- The woman and her husband must be literate 8. The woman does not have a hearing problem that would prevent her from understanding the voice recording, 9. Scoring 110 or above on the Premenstrual Syndrome Scale 10. Having regular menstrual cycles for the last six months, 11. Not having undergone bilateral oophorectomy or hysterectomy, 12. Not having been diagnosed with polycystic ovary syndrome, 13. Having no other medical disease in the last six months, 14. Participant who does not use oral contraceptives, 15. Without severe psychosomatic disorder, 16. Not pregnant or breastfeeding, 17. No history of cancer. 18. Those who do not use medical drugs to reduce premenstrual syndrome 19. Those who do not use herbal medicine to reduce premenstrual syndrome 20. Do not practice exercise, yoga, etc. to reduce premenstrual syndrome.
Exclusion criteria from the study:
- He or his spouse fills out the research survey forms incompletely,
- Wanting to leave the research at any stage of the research,
- Not participating in the final test,
- Pregnancy occurs,
- Receiving breathing exercise consultancy from another consultant during the study period
- Those who do the relaxation exercises incorrectly according to the Content of the Progressive Relaxation Exercises,
Data Collection Method and Duration Descriptive Characteristics Data Form, Perceived Stress Scale (PSS) and Family Assessment Scale will be applied to the sampled women and their spouses. Data collection will continue until the calculated sample number is reached.
Hypotheses:
H1: There is a difference between the mean stress level scores of women with premenstrual syndrome who take online progressive relaxation exercises and women who do not.
H2: There is a difference between the mean stress level scores of women with premenstrual syndrome who receive online progressive relaxation exercises and the spouses of women who do not.
H3: There is a difference between the mean family functionality score of women with premenstrual syndrome who receive online progressive relaxation exercises and those who do not.
H4: There is a difference between the mean family functionality scores of women with premenstrual syndrome who receive online progressive relaxation exercises and their spouses who do not.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The sample was divided into intervention and control groups
| Arm | Type | Receives |
|---|---|---|
| Progressive Relaxation Exercises | Experimental | Other: Progressive Relaxation Exercises, randomized pretest-posttestProgressive Relaxation Exercises, randomized pretest-posttest |
| control | No intervention | –Non-intervention |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (19 listed)
- Volunteering to participate in the study,
- Being married and living with his wife
- Being between the ages of 18-45,
- The woman's ability to use a mobile phone and/or computer to receive online (Zoom; vs) counseling and listen to exercises,
- The woman and her husband have a application or e-mail address that can use the googledocs application.
Key exclusion criteria (6 listed)
- He or his spouse fills out the research survey forms incompletely,
- Wanting to leave the research at any stage of the research,
- Not participating in the final test,
- Pregnancy occurs,
- Receiving breathing exercise consultancy from another consultant during the study period
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 Exercises, randomized pretest-posttestexperimental and control ,a randomized pretest-posttest study to examine | Other | Progressive Relaxation Exercises |
Primary outcome
Premenstrual Syndrome Scale
Time frame: The research period for a participant takes approximately 3 months.
It is a 44-item, five-point Likert-type scale (Never, Very little, Sometimes, Frequently, Continuously) developed by Gencdogan and measures the severity of premenstrual symptoms. In scoring the scale, the "Never" option is evaluated as 1 point, the "Very little" option is evaluated as 2 points, the "Sometimes" option is evaluated as 3 points, the "Often" option is evaluated as 4 points and the "Always" option is evaluated as 5 points. 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.
Family Assessment Scale
Time frame: The research period for a participant takes approximately four months.
Its original form was developed by Brown University and Butler Hospital in the United States within the framework of the Family Research Program. The family evaluation scale consists of 60 (sixty) questions and 7 sub-dimensions. It is a scale with four options and each item is scored between 1.00 (healthy) and 4.00 (unhealthy). Minimum 60 and maximum 240 points are taken from the scale. As the score increases, it indicates that family functionality is not good.
Perceived Stress Scale
Time frame: The research period for a participant takes approximately four months.
Perceived Stress Scale (PSS) Cohen consists of 14 items in total. The scale is a five-point Likert type in which each item is scored between "Never (0)" and "Very often (4)". The total score obtained from the scale ranges from 0 to 56, and the score obtained from 11 to 26 is considered low; 27-41 is medium; 42-56 indicates high stress level.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2024.
- Individual participant dataSharing planned: No
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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.
Tuba NU KORKMAZ ASLAN study chair
Necmettin Erbakan University
Gazi ÇU Kısa study chair
Cukurova University
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, randomized pretest-posttest in people with Premenstrual Syndrome and Exercises, run by Suleyman Demirel 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 19 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 6 May 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ayşe Sevim SU Akbay Kısa (05435872734 ext. nursing, ayse.sevim.32@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Premenstrual Syndrome Scale (time frame: The research period for a participant takes approximately 3 months.). The study lists 3 primary outcomes in all. 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 6 May 2024.