The Effect of Laughter Yoga on Pain, Fatigue, and General Well-Being in Cancer Patients and Their Caregivers

NCT ID: NCT06995248

Last Updated: 2025-05-29

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

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-05

Study Completion Date

2026-02-10

Brief Summary

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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.

Detailed Description

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Laughter yoga is a complementary mind-body practice that combines unconditional laughter with breathing techniques. It has been shown to reduce stress, improve mood, and promote psychological and physiological well-being. This randomized controlled trial will assess the effectiveness of a 6-session laughter yoga program on reducing pain and fatigue and enhancing general well-being in cancer patients and their caregivers. Participants in the experimental group will attend three sessions per week for two weeks, each lasting approximately 30-40 minutes. Outcomes will be measured before and after the intervention using validated scales.

Pain will be assessed using the Visual Analog Scale (VAS), which measures pain intensity on a scale from 0 (no pain) to 10 (worst possible pain).

Fatigue will be measured using the Visual Analogue Scale for Fatigue (VAS-F), a validated instrument that evaluates the intensity of fatigue and its impact on daily activities.

The General Well-Being Scale is a self-report instrument used to assess an individual's overall psychological well-being.he scale includes items related to mood, emotional state, and general life satisfaction. It is typically measured using a Likert-type format, where participants rate the frequency and intensity of their feelings or experiences on a scale (e.g., from "strongly disagree" to "strongly agree").

These validated scales will be administered at baseline (before the intervention) and at the end of the intervention (after the 6 sessions) to assess changes in the primary outcomes of pain, fatigue, and general well-being.

Conditions

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Laughter Yoga

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Laughter Yoga Group

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.

Group Type EXPERIMENTAL

Laughter Yoga

Intervention Type BEHAVIORAL

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

control arm

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Laughter Yoga

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Individuals who volunteer to participate in the study

Exclusion Criteria

* 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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Çankırı Karatekin University

OTHER

Sponsor Role lead

Responsible Party

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Birim Kiper

nurse

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Birim Kiper

Role: CONTACT

+90 543 680 4252

Facility Contacts

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Özlem Bulantekin Düzalan

Role: primary

+905063801930

References

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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.

Reference Type BACKGROUND
PMID: 31247017 (View on PubMed)

Other Identifiers

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0009000956254142

Identifier Type: -

Identifier Source: org_study_id

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