Laughter Yoga is Role in Enhancing Sleep and Well-being in the Elderly

NCT ID: NCT06685731

Last Updated: 2024-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-05

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

ELDERLY PEOPLE

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Laughter Yoga

Intervention Type OTHER

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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Laughter Yoga

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

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Laughter Therapy

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ataturk University

OTHER

Sponsor Role collaborator

Artvin Coruh University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Şerife Köleoğlu

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mehtap Tan, Prof. Dr.

Role: STUDY_DIRECTOR

Atatürk Universty

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Şavşat 1St Family Health Center

Artvin, Şavşat, Turkey (Türkiye)

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Şerife Köleoğlu

Role: CONTACT

+90 506 243 26 07

Mehtap Tan, Prof. Dr.

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Şerife Köleoğlu

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Artvin Çoruh Universty

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The Effect of Teleyoga in Liver Transplant Patients
NCT06563570 ACTIVE_NOT_RECRUITING NA