Vasomotor; SyndromeNCT05859594
The Effect of Laughter Yoga on Vasomotor Symptoms and Sleep Quality
A study testing Laughter yoga in people with Vasomotor; Syndrome and Sleep, run by Mersin University at 1 site in Turkey (Türkiye).
Trial summary
The research was planned as a prospective, randomized controlled experimental study to determine the effect of online laughter yoga applied to menopausal women on vasomotor symptoms (VMS) and sleep quality. Research Hypotheses ar below; H0: Online laughter yoga has no effect on VMS. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vasomotor; Syndrome, Sleep
- What is being tested?
- Laughter yoga
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 May 2023to 31 Aug 2023
- Phase
- Interventional
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 40 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- - enrolled in the Menopause School,
- Signing the Informed Consent Form,
- Willing to participate in the research,
- Able to read and write Turkish,
- Open to communication,
- Those who are between the ages of 40-60 and have not experienced menstruation for at least one year,
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- Experiencing at least one of the vasomotor symptoms
- A VMS severity of at least 4 according to the Visual Analog Scale,
- Not using drugs for the treatment of vasomotor symptoms,
- No chronic disease
- Regular laughter yoga is not practiced,
- Those who have not entered the menopause surgically,
- Women without psychiatric problems
Who cannot join
- - Not enrolled in Menopause School,
- Not signing the Informed Consent Form,
- Not willing to participate in the research,
- Cannot read and write Turkish,
- Unable to communicate
- Less than 40 years old, over 60 years old, experienced menstruation for at least one year,
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- Not experiencing vasomotor symptoms,
- VMS severity is less than 4 according to the Visual Analog Scale,
- Using drugs for the treatment of vasomotor symptoms,
- Having a chronic disease,
- Regular laughter yoga practice
- Those who have surgically entered the menopause,
- Women with psychiatric problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Laughter Yoga on Vasomotor Symptoms and Sleep Quality in Menopausal Women
The research was planned as a prospective, randomized controlled experimental study to determine the effect of online laughter yoga applied to menopausal women on vasomotor symptoms (VMS) and sleep quality. Research Hypotheses ar below; H0: Online laughter yoga has no effect on VMS. H1: Online laughter yoga has an effect on VMS. H0: Online laughter yoga has no effect on sleep quality. H1: Online laughter yoga has an effect on sleep quality.
Read the detailed description
The sample will consist of menopausal women aged 40-60 years and experiencing at least one of the VMS. Intervention group: Online laughter yoga will be applied to women by a researcher who has an internationally approved certificate. The intervention group will receive eight online laughter yoga sessions, two sessions per week for four weeks. In this study, the number of laughter yoga sessions was determined in line with the studies in the literature. Each laughter yoga session is planned to last approximately 40-45 minutes. Each session of laughter yoga consists of clapping and warm-up exercises, deep breathing exercises, childlike play and laughter.
No intervention will be applied to the control group.
- Conditions
- Vasomotor; Syndrome, Sleep
- Being tested
- Laughter yoga
- Keywords
- vasomotor symptoms, sleep quality, menopause, laughter yoga, laughter therapy
- Medical subject headings
- Syndrome, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laughter yogaOther
Also called Laughter therapy
Although the history of laughter yoga dates back to ancient times, its use in medicine has become widespread in the 21st century, while it is used to reduce pain, anxiety, stress, depression and fatigue, it is also a method that can be used to accelerate immunity, quality of life, happiness, sleep quality and recovery.
| Study group | Role | What they receive |
|---|---|---|
| Experimental (laughter yoga) group | Experimental | The intervention group will receive eight online laughter yoga sessions, two sessions per week for four weeks. In this study, the number of laughter yoga sessions was determined in line with the studies in the literature. Each laughter yoga session is planned to last approximately 40-45 minutes. Each session of laughter yoga consists of clapping and warm-up exercises, deep breathing exercises, childlike play and laughter. Receives: Other: Laughter yoga |
| Control group | No intervention | The control group will receive no intervention for 4 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scala (VAS)
The Visual Analog Scale is used to measure the pain perceived by the person. There is a 10 cm mark on the one end of the scale, where there is no pain (zero), and on the other end there is the most severe (10) pain. Between the (100 mm.) part, the individual can indicate his or her pain by drawing a line, putting a dot or pointing. The distance from the point where there is no pain to the point marked by the individual is measured in centimeters, and the value found indicates the severity of the individual's pain. In this study, VAS will be used for hot flashes, night sweats and sweating experienced by women. Women will indicate where their situation is appropriate on this line by drawing a line or by placing a dot/mark.
Measured: change from baseline, at the end of 4th week of intervention.
Secondary outcomes (1)
Sleep quality
The Pittsburgh Sleep Quality Index (PUKI) will be used to assess sleep quality. PUKI sleep quality; subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleeping pills, and daytime dysfunction. Those with a total score above five on the PUKI are considered "poor", and those with a score of five or below are considered "good".
Measured: change from baseline, at the end of 4th week of intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start2 May 2023
- Primary completion31 Jul 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vasomotor; 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
- Prospective, parallel, two arm, randomized controlled clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahu AKSOY, Mersin University
- Investigators
- Ahu Aksoy Can, PhD, Principal investigator, Mersin University Nursing Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05859594
- Sponsor's protocol ID
- 246
- Status last verified
- Oct 2026
- First submitted
- 5 May 2023
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aksoy-Can A, Guner-Emul T, Degirmenci F, Buldum A, Aksu A, Vefikulucay-Yilmaz D. The Effect of Laughter Yoga on Vasomotor Symptoms and Sleep Quality in Menopausal Women: A Randomized Controlled Trial. Holist Nurs Pract. 2025 Jul-Aug 01;39(4):192-200. doi: 10.1097/HNP.0000000000000690. Epub 2025 Jun 19.
PubMed 39196654