The Effect of Laughter Yoga on Self-Care, Quality of Life and Stress Level in Menopause
1 other identifier
interventional
60
1 country
1
Brief Summary
In order to evaluate the effects of laughter yoga on the quality of life, stress, cortisol, blood pressure levels and conscious self-care powers of menopausal women, it will be performed in two stages (the first stage is qualitative and the second stage is randomized controlled) on menopausal women in the TRNC Famagusta region.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 22, 2023
CompletedFirst Posted
Study publicly available on registry
June 13, 2023
CompletedStudy Start
First participant enrolled
June 30, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 16, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 16, 2024
CompletedJune 13, 2023
June 1, 2023
8 months
May 22, 2023
June 12, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
The Effect of Laughter Yoga on Self-Care in Menopause
Conscious Awareness Based Self-Care Scale: The Conscious Awareness-Based Self-Care Scale developed by Cook-Cottone and Guyker (2018) is a multidimensional tool that examines self-care through the perceived involvement of individuals in the areas of physical, cognitive, emotional and social care and consists of 33 items. Conscious self-care is measured in six sub-dimensions: physical care, supportive relationships, mindfulness, self-compassion and purpose, conscious relaxation and supportive structure. The internal consistency coefficient was .89 for the general scale and .69, .86, .92, .83, .77, and .77 for the subscales, respectively. The Turkish validity and reliability study of the scale was carried out by Sünbül et al. (2018) and the internal consistency coefficient was .89 for the general scale and .72, .81, .81, .83, .66, and .80 for the subscales, respectively. E-mail permission has been obtained for the use of the scale.
8 WEEKS
The Effect of Laughter Yoga on Stress Level in Menopause
Perceived Stress Scale: The Perceived Stress Scale (PSS) was developed by Cohen, Kamarck, and Mermelstein in 1983. The scale consists of a total of 14 items and is designed to measure how stressful the individual perceives the situations in his life. Turkish validity and reliability studies of the scale were carried out by Eskin et al. in 2013. The items of the 14-item form preferred in this study are scored between 0-4. Scoring of the scale; Never (0), Almost never (1), Sometimes (2), Quite often (3), and Very often (4). The score of PSS-14 varies between 0-56; A high score means that the perception of stress is high. In scale; Items 4, 5, 6, 7, 9, 10 and 13 are reverse scored. The test-retest reliability coefficient of the scale was 0.87 and the cronbach alpha internal consistency coefficient was 0.84. E-mail permission was obtained for the use of the scale.
8 WEEKS
The Effect of Laughter Yoga on Quality of Life Scale Level in Menopause
Self-Care Strength Scale (PSAS): The scale used to measure an individual's self-care ability or self-care power was developed in English by Kearney and Fleicher (1979) with 43 items, and an abbreviated 35-item Turkish form was adapted by Nahcivan. The scale focused on individuals' self-assessment of their involvement in self-care actions. Each statement is scored from 0 to 4. In the Turkishized scale, 8 items (3, 6, 9, 13, 19, 22, 26 and 31) are evaluated as negative and the scoring is reversed. The maximum score is 140. The high score obtained from the scale indicates the high level of self-care or self-care ability and power of the individual. There is no cut off value. E-mail permission has been obtained for the use of the scale.
8 WEEKS
Study Arms (2)
Laughter Yoga Group
EXPERIMENTALWhen we look at the literature, the Laughter Yoga practice is held between 2 weeks and 10 weeks, once a week, 5 times a week, 2 weeks and lasting approximately 25-45 minutes. In this study, the intervention will be implemented within 8 weeks. To the women who constitute the intervention group; After giving short-term self-care training in Menopause for 8 weeks, relaxation will be applied after the practice of Laughter yoga, which starts with breathing exercises, warm-up exercises, childlike games and has different exercises in each session. The research will be carried out in the Famagusta Municipality Development Academy, in a bright hall where women can take a U shape, everyone will be face to face, and will not be disturbed during the application.
Control Group
NO INTERVENTIONRoutine care was given to the control group
Interventions
Laughter yoga is a childlike practice where group members make eye contact with each other. It is a breath yoga practiced by imitating games and fake laughing. Brain the effects of real laughter on the body, as it cannot distinguish between fake and real laughter. showing positive effects. It consists of sessions lasting at least 20 minutes and an average of 45 minutes.
Eligibility Criteria
You may qualify if:
- Those who have been in menopause for the last five years
- At least 1 year past the last menstrual period
- Women between the ages of 45-60
- Willingness to participate in the research
- No communication barrier (cognitive affective)
You may not qualify if:
- Not knowing Turkish
- Having surgical menopause
- State their willingness to withdraw from the research voluntarily
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dilek Karaoğlan Gülevi
Famagusta, 99450, Cyprus
Related Publications (6)
Treloar AE. Menstrual cyclicity and the pre-menopause. Maturitas. 1981 Dec;3(3-4):249-64. doi: 10.1016/0378-5122(81)90032-3.
PMID: 7334935RESULTGrindler NM, Santoro NF. Menopause and exercise. Menopause. 2015 Dec;22(12):1351-8. doi: 10.1097/GME.0000000000000536.
PMID: 26382311RESULTSussman M, Trocio J, Best C, Mirkin S, Bushmakin AG, Yood R, Friedman M, Menzin J, Louie M. Prevalence of menopausal symptoms among mid-life women: findings from electronic medical records. BMC Womens Health. 2015 Aug 13;15:58. doi: 10.1186/s12905-015-0217-y.
PMID: 26271251RESULTWoods NF, Mitchell ES. Symptoms during the perimenopause: prevalence, severity, trajectory, and significance in women's lives. Am J Med. 2005 Dec 19;118 Suppl 12B:14-24. doi: 10.1016/j.amjmed.2005.09.031.
PMID: 16414323RESULTThurston RC, Joffe H. Vasomotor symptoms and menopause: findings from the Study of Women's Health across the Nation. Obstet Gynecol Clin North Am. 2011 Sep;38(3):489-501. doi: 10.1016/j.ogc.2011.05.006.
PMID: 21961716RESULTGuerin E, Goldfield G, Prud'homme D. Trajectories of mood and stress and relationships with protective factors during the transition to menopause: results using latent class growth modeling in a Canadian cohort. Arch Womens Ment Health. 2017 Dec;20(6):733-745. doi: 10.1007/s00737-017-0755-4. Epub 2017 Jul 13.
PMID: 28707156RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- SENIOR INSTRUCTOR
Study Record Dates
First Submitted
May 22, 2023
First Posted
June 13, 2023
Study Start
June 30, 2023
Primary Completion
February 16, 2024
Study Completion
February 16, 2024
Last Updated
June 13, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- SAP, ICF, CSR