Menopause, Laughter Therapy, and Well-Being (NCT07522840) | Clinical Trial Compass
CompletedNot Applicable
Menopause, Laughter Therapy, and Well-Being
Turkey (Türkiye)97 participantsStarted 2024-12-01
Plain-language summary
The intervention will be conducted by Assist. Prof. Dr. Nurten ÖZÇALKAP. No invasive procedures will be performed; participants will engage in deep breathing, warm-up exercises, playful activities, and laughter exercises. The researcher holds an internationally certified training in laughter therapy.
Intervention Group
Participants will be invited face-to-face, informed about the study, and provide consent. They will be assigned to groups of 8 - 9 and receive laughter yoga twice weekly for a total of 8 sessions (20-40 minutes each) in a suitable hospital or institutional setting.
Baseline assessments will include the Introductory Information Form, Brain Fog Scale, Psychological Well-Being Scale, and Sleep Quality Scale. These scales will be re-administered after the 8th session.
Control Group Participants will be recruited similarly and provide consent. Baseline assessments will be conducted using the same instruments. Post-test assessments will be performed 4 weeks later.
After study completion, control group participants who wish will be offered one session of laughter yoga.
Who can participate
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Willingness to participate in the study
* Ability to communicate
* Having entered menopause within the last 3 years
* Having experienced natural menopause
* Being literate
Exclusion Criteria:
* Having undergone surgical menopause
* Having a serious psychiatric or neurological disorder (e.g., schizophrenia, bipolar disorder, dementia, epilepsy)
* Having a chronic disease that may significantly affect overall quality of life and cognitive functions
* Having a physical condition that prevents participation in laughter therapy sessions (e.g., respiratory distress, vertigo, incontinence, severe cardiac disease)
* Using antidepressants or engaging in other non-pharmacological methods to reduce stress
* Receiving hormone replacement therapy
* Having experienced a traumatic event within the past year
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.