NCT06308601

Brief Summary

Purpose: This project aimed to examine the effects of laughter yoga, which is accepted as an international nursing initiative, on loneliness, anger and salivary cortisol levels in visually impaired individuals. When the national and international literature was examined, no project was found that measured the results of laughter yoga as an intervention for visually impaired individuals. For this reason, planning an original project in this field aims to contribute to the literature. Thanks to the evidence obtained, laughter yoga, an innovative approach, can be disseminated in institutions and organizations serving visually impaired individuals as an evidence-based practice that can improve the social skills of individuals. Scope and Target Audience: The project will be carried out with visually impaired individuals receiving services in the Disabled Persons Department within the Atatürk Provincial Public Library located in Konak district of Izmir. In this section, services are provided to 250 members who actively use the library and to visually impaired people from all over Turkey. Method and Expected Result: The project was planned in a randomized controlled, pre-test post-test, single-blind follow-up consultancy design. With this initiative, a social rehabilitation environment will be provided for visually impaired individuals by taking an approach based on respect, understanding and awareness. Laughter yoga is expected to reduce the level of anger and loneliness in visually impaired individuals. At the same time, laughter yoga is expected to reduce cortisol levels, which are known to increase when faced with stress factors, and increase serotonin, which is associated with happiness and vitality, and endorphine, known as the body's natural painkiller. With laughter yoga sessions, a social environment will be created where visually impaired individuals will have an active and independent experience. Thanks to the expected evidence, laughter yoga can be popularized both in visually impaired individuals and in individuals with other disabilities. Within the scope of protecting and improving health, laughter yoga can be planned to be carried out as a routine nursing practice in disabled centers. Thus, by creating an environment where visually impaired individuals and nurses come together, a more accessible health service will be provided to individuals with special needs.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 13, 2024

Completed
9 months until next milestone

Study Start

First participant enrolled

December 2, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 3, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 3, 2025

Completed
Last Updated

March 26, 2025

Status Verified

March 1, 2025

Enrollment Period

1 month

First QC Date

January 27, 2024

Last Update Submit

March 22, 2025

Conditions

Keywords

Visually impairedLaughter YogaNursingAngerLonelinessCortisol

Outcome Measures

Primary Outcomes (3)

  • salivary cortisol test

    Saliva samples will be taken from the experimental group and control group and tested in the laboratory.

    1. test: 1 day before interventions 2.test: 1 day after interventions

  • UCLA(University of California, Los Angeles) Loneliness Scale

    The survey form will be read to visually impaired individuals and their answers will be marked and filled out. Rating: 4-point Likert (1 = I never experience it - 4 = I often experience it). Scale Scoring: Scores between 20-80 are taken from the scale. As the score increases, the level of loneliness increases.

    1. test: 1 day before interventions 2.test: 1 day after interventions

  • Trait Anger Scale

    The survey form will be read to visually impaired individuals and their answers will be marked and filled out. Rating: 4-point Likert (1 = never - 4 = always) Scale Scoring: The score that can be obtained from the scale varies between 10 and 40. As the score increases, the anger level also increases.

    1. test: 1 day before interventions 2.test: 1 day after interventions

Study Arms (2)

experimental group

EXPERIMENTAL

8 sessions of laughter yoga will be applied to the experimental group.

Other: Laughter yoga

control group

NO INTERVENTION

No application will be made to the control group. After the research is completed, laughter yoga can be applied by the researcher, at the request of the experimental group, within the framework of ethical responsibilities.

Interventions

Laughter is an innate, most natural, sincere and universal response to humorous stimuli. Philosophically, it is explained by relief theory, conflict theory and superiority theory (Öztürk \& Tezel, 2021). The emergence of laughter yoga was made by Dr., an Indian medical doctor, in 1995. It was created by combining breathing exercises and unconditional laughter with the work of Madan Kataria and his wife Madhuri Kataria. In laughter yoga, the individual can laugh in a simulated way with the interaction of group members, without a funny situation, joke or joke. The body cannot distinguish between real and unreal laughter, and fake laughter begins to turn into real laughter (Kataria, 2011).

experimental group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Receiving service from Izmir Ataturk Provincial Public Library
  • Being visually impaired
  • Volunteering to participate in the research.

You may not qualify if:

  • Those diagnosed with diabetes mellitus, hypertension, hypothyroidism, hyperaldosteronism, pregnancy, malignancy, congestive heart failure, psychotic disorder, chronic liver failure, nephrotic syndrome, chronic renal failure and those who are on continuous medication (Angiotensin converting enzyme inhibitors, angiotensin receptor blocker, phenytoin, barbiturate). Visually impaired individuals who use oral contraceptives, etc.) will be excluded from the scope as their salivary cortisol level may be affected.
  • Individuals with conditions for which laughter yoga is not recommended (having undergone abdominal surgery in the last three months, uncontrolled hypertension, glaucoma, hernia, epilepsy) will be excluded from the scope.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ege University

Bornova, İzmir, 35030, Turkey (Türkiye)

Location

Related Publications (5)

  • Yazdani M, Esmaeilzadeh M, Pahlavanzadeh S, Khaledi F. The effect of laughter Yoga on general health among nursing students. Iran J Nurs Midwifery Res. 2014 Jan;19(1):36-40.

    PMID: 24554958BACKGROUND
  • Kuru Alici N, Zorba Bahceli P. Effects of Laughter Therapy on Life Satisfaction and Loneliness in Older Adults Living in Nursing Homes in Turkey: A Parallel Group Randomized Controlled Trial. Rehabil Nurs. 2021 Mar-Apr 01;46(2):104-112. doi: 10.1097/RNJ.0000000000000266.

    PMID: 33646727BACKGROUND
  • Ozturk FO, Bayraktar EP, Tezel A. The effect of laughter yoga on loneliness, psychological resilience, and quality of life in older adults: A pilot randomized controlled trial. Geriatr Nurs. 2023 Mar-Apr;50:208-214. doi: 10.1016/j.gerinurse.2023.01.009. Epub 2023 Feb 15.

    PMID: 36804028BACKGROUND
  • Kuru Alici N, Zorba Bahceli P, Emiroglu ON. The preliminary effects of laughter therapy on loneliness and death anxiety among older adults living in nursing homes: A nonrandomised pilot study. Int J Older People Nurs. 2018 Dec;13(4):e12206. doi: 10.1111/opn.12206. Epub 2018 Jul 13.

    PMID: 30004172BACKGROUND
  • Lee JS, Lee SK. The Effects of Laughter Therapy for the Relief of Employment-Stress in Korean Student Nurses by Assessing Psychological Stress Salivary Cortisol and Subjective Happiness. Osong Public Health Res Perspect. 2020 Feb;11(1):44-52. doi: 10.24171/j.phrp.2020.11.1.07.

    PMID: 32149041BACKGROUND

Related Links

MeSH Terms

Conditions

LaughterVision Disorders

Interventions

Laughter Therapy

Condition Hierarchy (Ancestors)

Nonverbal CommunicationCommunicationBehaviorSensation DisordersNeurologic ManifestationsNervous System DiseasesEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeutics

Study Officials

  • Gülengül Mermer, assoc. prof.

    https://unisis.ege.edu.tr/researcher=gulengul.s.mermer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Statistical evaluation of the research results will be made by an expert other than the researcher.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Research Population: The population of this research is the visually impaired individuals who received service from the Disabled Department within the Ataturk Provincial Public Library in Konak district of Izmir province between 2023-2024. Research Sample: In the research, "G. Using the "Power-3.1.9.7" program, the sample size of the study was calculated at a 95% confidence level before the data collection phase. The standardized effect size was found to be 0.90 when calculated based on the mean and standard deviation values of previous studies. As a result, the minimum number of samples was calculated as 28 for each group with a 95% confidence level, 0.05 alpha value, 0.90 intervention effect size and 95% theoretical power. It is aimed to reach 56 people in total. Considering that there will be a 20% case loss in experimental studies in the literature (Pan, et al., 2019), the number of samples was determined as 60 (30 interventions; 30 controls).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nurse

Study Record Dates

First Submitted

January 27, 2024

First Posted

March 13, 2024

Study Start

December 2, 2024

Primary Completion

January 3, 2025

Study Completion

January 3, 2025

Last Updated

March 26, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations