The Effect of Laughter Yoga on Vasomotor Symptoms and Sleep Quality

NCT05859594 | Completed

• 1 other identifier: 246
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Vasomotor; Syndrome; Sleep

Keywords

vasomotor symptoms; sleep quality; menopause; laughter yoga; laughter therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  change from baseline, at the end of 4th week of intervention.

Secondary Outcomes (1)

• Sleep quality

  change from baseline, at the end of 4th week of intervention.

Study Arms (2)

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.

Other: Laughter yoga

Control group

NO INTERVENTION

The control group will receive no intervention for 4 weeks.

Interventions

Laughter yoga OTHER

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.

Also known as: Laughter therapy

Experimental (laughter yoga) group

Eligibility Criteria

• Age: 40 Years - 60 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- 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,
• 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

You may not qualify if:

• \- 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,
• 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

Sponsors & Collaborators

• Mersin University: lead

Study Sites (1)

Mersin University

Yenişehir, Mersin, Turkey (Türkiye)

Location

Related Links

• The effect of online laughter therapy on depression, anxiety, stress, and loneliness among nursing students during the Covid-19 pandemic

MeSH Terms

Conditions

Syndrome; Sleep Initiation and Maintenance Disorders

Interventions

Laughter Therapy

Condition Hierarchy (Ancestors)

Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics

Study Officials

• Ahu Aksoy Can, PhD

  Mersin University Nursing Faculty

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Statistical analysis of the data will be done by an expert independent of the research.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant, PhD

Model Details: Prospective, parallel, two arm, randomized controlled clinical trial

Study Record Dates

• First Submitted: May 5, 2023
• First Posted: May 16, 2023
• Study Start: May 2, 2023
• Primary Completion: July 31, 2023
• Study Completion: August 31, 2023
• Last Updated: September 8, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)