Effect of Online Exercises for Premenstrual Syndrome on Couple's Stress and Family Function

Premenstrual Syndrome Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06370429
• Other study ID #: 8743432956-050.99-621064
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 15, 2024
• Est. completion date: December 30, 2024

Study information

• Verified date: May 2024
• Source: Suleyman Demirel University
• Contact: Ayse Sevim SU Akbay Kisa
• Phone: 05435872734
• Email: ayse.sevim.32[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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:

1. He or his spouse fills out the research survey forms incompletely,

2. Pregnancy occurs,

3. 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.

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:

1. 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.

7. 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:

1. He or his spouse fills out the research survey forms incompletely,

2. Wanting to leave the research at any stage of the research,

3. Not participating in the final test,

4. Pregnancy occurs,

5. Receiving breathing exercise consultancy from another consultant during the study period

6. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Volunteering to participate in the study,

2. Being married and living with his wife

3. Being between the ages of 18-45,

4. The woman's ability to use a mobile phone and/or computer to receive online (Zoom; vs) counseling and listen to exercises,

5. The woman and her husband have a application or e-mail address that can use the googledocs application.

6. The woman and her husband must be literate

7. The woman does not have a hearing problem that would prevent her from understanding the voice recording,

8. Scoring 110 or above on the Premenstrual Syndrome Scale

9. Having regular menstrual cycles for the last six months,

10. Not having undergone bilateral oophorectomy or hysterectomy,

11. Not having been diagnosed with polycystic ovary syndrome,

12. Having no other medical disease in the last six months,

13. Participant who does not use oral contraceptives,

14. Without severe psychosomatic disorder,

15. Not pregnant or breastfeeding,

16. No history of cancer.

17. Those who do not use medical drugs to reduce premenstrual syndrome

18. Those who do not use herbal medicine to reduce premenstrual syndrome

19. Do not practice exercise, yoga, etc. to reduce premenstrual syndrome.

Exclusion Criteria:

1. He or his spouse fills out the research survey forms incompletely,

2. Wanting to leave the research at any stage of the research,

3. Not participating in the final test,

4. Pregnancy occurs,

5. Receiving breathing exercise consultancy from another consultant during the study period

6. Those who do the relaxation exercises incorrectly according to the Content of the Progressive Relaxation Exercises CD,

Related Conditions & MeSH terms

• Exercises
• Family Characteristics
• Premenstrual Syndrome
• Syndrome

Intervention

Other:
• Progressive Relaxation Exercises, randomized pretest-posttest
experimental and control ,a randomized pretest-posttest study to examine

Locations

Country	Name	City	State
Turkey	Suleyman Demirel University	Isparta

Sponsors (1)

Lead Sponsor	Collaborator
Suleyman Demirel University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	The research period for a participant takes approximately 3 months.
Primary	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.	The research period for a participant takes approximately four months.
Primary	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.	The research period for a participant takes approximately four months.