- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06685731
Laughter Yoga is Role in Enhancing Sleep and Well-being in the Elderly
The Effects of Laughter Yoga on Sleep Quality, Vitality, Active Aging, and Quality of Life in Elderly Individuals
Objective:
The study aims to evaluate the effects of Laughter Yoga on sleep quality, vitality, active aging, and quality of life in individuals aged 60 and over.
Method:
This randomized controlled experimental study will be conducted between 01.09.2024 and 31.12.2024 with elderly individuals aged 60 and over who are registered at Şavşat Family Health Center No. 1. The study population consists of 6,797 individuals. Participants will be randomly assigned to an experimental group (30) and a control group (30) using a simple randomization method. Data will be collected using a Personal Information Form, Mini-Mental State Examination, Active Aging Scale, Pittsburgh Sleep Quality Index, Subjective Vitality Scale, and Quality of Life Scale for the Elderly. The experimental group will participate in 12 Laughter Yoga sessions, conducted twice a week for 6 weeks, with each session lasting 40 minutes. No intervention will be applied to the control group. At the end of the 6th week, final measurements will be taken from both groups at the family health center.
Study Overview
Detailed Description
Laughter yoga offers various approaches and insights related to humor, is low-cost, and can be easily practiced regardless of time and place, making it a highly effective and practical intervention. Research on the physiological health effects of laughter yoga has demonstrated that it enhances muscle activation, relaxes muscles, increases respiratory rate, stimulates circulation, improves oxygen saturation, reduces stress hormones (e.g., adrenaline, noradrenaline, cortisol), elevates beta-endorphin levels, alleviates pain, and enhances cognitive function. Additionally, the positive effects of humor and emotions such as happiness and optimism on psychosocial health are well-recognized. Studies on the psychosocial health outcomes of laughter yoga indicate that it reduces stress, anxiety, and depression, while improving mood, self-esteem, self-efficacy, happiness, optimism, and energy levels. Furthermore, it helps reduce interpersonal conflicts and tensions, enhances social relationships and quality of life, and boosts psychological well-being.
Although the use of laughter yoga among older adults is limited, research has shown that it has a positive impact on depression, anxiety, sleep quality, quality of life, loneliness, life satisfaction, blood pressure, and pain in this population.A review of the literature suggests that laughter yoga may be effective in improving certain physiological and psychosocial health outcomes, highlighting the need for further research.
This study aims to evaluate the effectiveness of laughter yoga in nursing practice, support its application, and investigate its potential benefits for elderly individuals. Specifically, it seeks to assess its positive impact on sleep quality, vitality, active aging, and overall quality of life, while confirming that it poses no adverse side effects for older adults.
Elderly individuals registered at the family health center will be introduced to the study and provided with detailed information regarding its objectives. Those who meet the inclusion criteria and express interest in participating will be identified. After obtaining informed consent, participants will be assigned to groups according to a randomization list. The researcher has obtained an "International Laughter Yoga Leadership Certificate" to conduct the Laughter Yoga intervention within the scope of this study.
The Personal Information Form, Mini-Mental State Examination, Active Aging Scale, Pittsburgh Sleep Quality Index, Subjective Vitality Scale, and Quality of Life Scale for the Elderly will be administered to both groups through face-to-face interviews conducted by the researcher (pre-test). Participants in the experimental group will be provided with comprehensive information about the Laughter Yoga intervention.
The experimental group will participate in 12 Laughter Yoga sessions, conducted twice a week over a 6-week period, with each session lasting 40 minutes. As the contagious nature of laughter facilitates easier participation when group size is larger, participants will not be divided into smaller groups during the Laughter Yoga sessions. The sessions will be led by the researcher, and their duration and frequency have been determined based on a thorough review of the relevant literature. Sessions will be held in the gymnasium of the institution where the researcher is employed, under optimal conditions. No intervention will be applied to the control group. At the end of the 6th week, participants from both groups will be invited to the family health center, where the Active Aging Scale, Pittsburgh Sleep Quality Index, Subjective Vitality Scale, and Quality of Life Scale for the Elderly will be administered again (post-test).
Participants in both groups will continue using their routine medications throughout the 6-week study period. Upon completion of the research, elderly individuals in the control group will be offered information on Laughter Yoga upon request.
Elderly individuals registered at the family health center will be introduced to the study and provided with detailed information regarding its objectives. Those who meet the inclusion criteria and express interest in participating will be identified. After obtaining informed consent, participants will be assigned to groups according to a randomization list. The researcher has obtained an International Laughter Yoga Leadership Certificate to conduct the Laughter Yoga intervention within the scope of this study.
The Personal Information Form, Mini-Mental State Examination, Active Aging Scale, Pittsburgh Sleep Quality Index, Subjective Vitality Scale, and Quality of Life Scale for the Elderly will be administered to both groups through face-to-face interviews conducted by the researcher (pre-test). Participants in the experimental group will be provided with comprehensive information about the Laughter Yoga intervention.
The experimental group will participate in 12 Laughter Yoga sessions, conducted twice a week over a 6-week period, with each session lasting 40 minutes. As the contagious nature of laughter facilitates easier participation when group size is larger, participants will not be divided into smaller groups during the Laughter Yoga sessions. The sessions will be led by the researcher, and their duration and frequency have been determined based on a thorough review of the relevant literature. Sessions will be held in the gymnasium of the institution where the researcher is employed, under optimal conditions. No intervention will be applied to the control group. At the end of the 6th week, participants from both groups will be invited to the family health center, where the Active Aging Scale, Pittsburgh Sleep Quality Index, Subjective Vitality Scale, and Quality of Life Scale for the Elderly will be administered again (post-test).
Participants in both groups will continue using their routine medications throughout the 6-week study period. Upon completion of the research, elderly individuals in the control group will be offered information on Laughter Yoga upon request.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Şerife Köleoğlu
- Phone Number: +90 506 243 26 07
- Email: srfkoleoglu@gmail.com
Study Contact Backup
- Name: Mehtap Tan, Prof. Dr.
Study Locations
-
-
Şavşat
-
Artvin, Şavşat, Turkey, 08700
- Recruiting
- Şavşat 1St Family Health Center
-
Contact:
- Şerife Köleoğlu
- Email: srfkoleoglu@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Reside in Şavşat,
- Aged 60 or over,
- No issues with vision, hearing, or perception,
- Scored 24 or higher on the Mini-Mental State Examination,
- Not undergoing psychiatric treatment,
- No physical limitations that would impede participation in laughter yoga (e.g., fractures, open wounds, or muscle weakness in the hands, wrists, or arms),
- Literate,
- Open to communication,
- Willing to participate in the study.
Exclusion Criteria:
- Scored below 24 on the Mini-Mental State Examination,
- Severe hearing or perceptual impairments that hinder communication,
- Major psychiatric disorders,
- Underwent surgery within the last three months,
- Medical conditions that could cause physical strain or increase abdominal pressure during laughter yoga (e.g., bleeding hemorrhoids, any type of hernia, persistent cough, severe back pain, heart disease, hypertension, urinary incontinence, epilepsy), and individuals with oncological conditions will be excluded from the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Participant Group
Personal Information Form, Mini-Mental State Examination, Active Aging Scale, Pittsburgh Sleep Quality Index, Subjective Vitality Scale, and Quality of Life Scale for Elderly Individuals will be administered to elderly individuals via face-to-face interviews conducted by the researcher. Elderly individuals will be provided with information about the Laughter Yoga sessions. The elderly participants will undergo a total of 12 Laughter Yoga sessions, with each session lasting 40 minutes, conducted twice a week for 6 weeks. Participants' phone numbers will be collected, and they will be contacted twice a week to ensure their attendance at the Laughter Yoga sessions. |
Laughter Yoga Intervention: Laughter Yoga is composed of four stages: deep breathing exercises, clapping and warm-up exercises, childlike play, and laughter exercises. These stages are designed to remove barriers to laughter, enhance emotional expression through childlike play, and prepare the lungs for laughter exercises. Before the Laughter Yoga session begins, participants will be introduced to both the practice itself and to Laughter Yoga in general. The session will then proceed according to the following structure: Deep Breathing Exercises: Participants inhale through the nose for 4-5 seconds, hold their breath for 2-3 seconds, and exhale through the mouth, with lips pursed, for one second longer than the inhalation, while smiling or laughing. This exercise is performed for 10-15 minutes. Clapping and Warm-Up Exercises: Participants clap with palms and fingertips touching, keeping their hands parallel. This stimulates acupressure points in the hands. To increase group energy, a
Other Names:
|
|
No Intervention: Control group
Personal Information Form, Mini-Mental State Examination, Active Aging Scale, Pittsburgh Sleep Quality Index, Subjective Vitality Scale, and Quality of Life Scale for the Elderly will be administered to elderly individuals through face-to-face interviews conducted by the researcher. No intervention will be applied to the elderly individuals in this group. Phone numbers of the participants in this group will be collected, and they will be contacted once a week to check on their status. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pre-test
Time Frame: Initial enrollment in the study
|
Mini Mental State Test (MMST): Assesses cognitive function on a 0-30 scale; higher scores indicate better cognitive function.
The score will be reported independently.
|
Initial enrollment in the study
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Active Aging Scale
Time Frame: From enrollment to the end of treatment at 6 weeks
|
Scores range from 0 to 272 across four subscales, with higher scores indicating greater active aging.
This score is reported as a separate outcome.
|
From enrollment to the end of treatment at 6 weeks
|
|
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: From enrollment to the end of treatment at 6 weeks
|
Measures sleep quality, where scores of 5 or more indicate poor sleep quality.
PSQI results are reported separately.
|
From enrollment to the end of treatment at 6 weeks
|
|
Subjective Vitality Scale (SVS)
Time Frame: From enrollment to the end of treatment at 6 weeks
|
Ranges from 7 to 49, with higher scores reflecting higher vitality.
It is reported as an independent measure of vitality.
|
From enrollment to the end of treatment at 6 weeks
|
|
CASP-13 Quality of Life Scale
Time Frame: From enrollment to the end of treatment at 6 weeks
|
Evaluates quality of life in terms of autonomy and satisfaction, with higher scores indicating better life quality, and will be reported separately.
|
From enrollment to the end of treatment at 6 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Mehtap Tan, Prof. Dr., Ataturk Universty
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Artvin Çoruh Universty
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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