Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06370429
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-06
First Post:
2024-04-12
Brief Title:
Effect of Online Exercises for Premenstrual Syndrome on Couples Stress and Family Function
Sponsor:
Suleyman Demirel University
Organization:
Suleyman Demirel University
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
36 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 womans ability to use a mobile phone andor 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
36 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 womans ability to use a mobile phone andor 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
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
36 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 31 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 082 and an error level of 005 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 womans ability to use a mobile phone andor 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
Universe of Research The universe of the research It will consist of women and their spouses with premenstrual syndrome complaints who use social media
36 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 31 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 082 and an error level of 005 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 womans ability to use a mobile phone andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None