NCT06995248

Brief Summary

This study aims to evaluate the effect of laughter yoga on pain, fatigue, and general well-being in cancer patients and their caregivers. Participants will be randomly assigned to either a laughter yoga intervention group or a control group. The intervention group will receive six sessions of laughter yoga over two weeks. Outcomes will be measured before and after the intervention.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Start

First participant enrolled

May 5, 2025

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

May 10, 2025

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 29, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 2, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2026

Completed
Last Updated

May 29, 2025

Status Verified

May 1, 2025

Enrollment Period

4 months

First QC Date

May 10, 2025

Last Update Submit

May 27, 2025

Conditions

Keywords

paincaregivesfatiguelaughter therapycancer patients

Outcome Measures

Primary Outcomes (1)

  • Change in Pain Level

    Pain will be measured using the Visual Analog Scale (VAS) at baseline and one week after the final session to assess the effectiveness of the intervention.

    Before and one week after the 6-session laughter yoga program

Secondary Outcomes (1)

  • Change in Fatigue Level

    Before the intervention and one week after

Study Arms (2)

Laughter Yoga Group

EXPERIMENTAL

Participants in this group will receive a 6-session laughter yoga program over a 2-week period. Each session includes breathing exercises, intentional laughter practices, and light physical activity. The intervention is designed to reduce stress, enhance well-being, and improve pain and fatigue levels.

Behavioral: Laughter Yoga

control arm

NO INTERVENTION

Participants in this group will not receive any behavioral intervention during the study period. They will only complete the pre- and post-assessment questionnaires at the same intervals as the experimental group, allowing for outcome comparison.

Interventions

Laughter YogaBEHAVIORAL

Laughter yoga sessions are a behavioral intervention regularly conducted to help participants reduce stress, build social connections, and enhance overall well-being.

Laughter Yoga Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals who volunteer to participate in the study

You may not qualify if:

  • having asthma or COPD
  • being under 18 or over 65 years of age, and having any health condition or disability that impairs communication (such as visual or hearing impairments, or neurological or psychiatric disorders).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Ankara, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • Morishima T, Miyashiro I, Inoue N, Kitasaka M, Akazawa T, Higeno A, Idota A, Sato A, Ohira T, Sakon M, Matsuura N. Effects of laughter therapy on quality of life in patients with cancer: An open-label, randomized controlled trial. PLoS One. 2019 Jun 27;14(6):e0219065. doi: 10.1371/journal.pone.0219065. eCollection 2019.

    PMID: 31247017BACKGROUND

MeSH Terms

Conditions

PainFatigue

Interventions

Laughter Therapy

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeutics

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
nurse

Study Record Dates

First Submitted

May 10, 2025

First Posted

May 29, 2025

Study Start

May 5, 2025

Primary Completion

September 2, 2025

Study Completion

February 10, 2026

Last Updated

May 29, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations