Clinical trial NCT06995248: The Effect of Laughter Yoga on Pain, Fatigue, and General Well-Being in Cancer Patients and Their Caregivers
Official title: Effect of Laughter Yoga on Pain, Fatigue and General Well-Being in Cancer Patients and Their Caregivers: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Laughter Yoga
Keywords: pain
caregives
fatigue
laughter therapy
cancer patients
Lead sponsor: Çankırı Karatekin University
Sponsor class: OTHER
First posted: 2025-05-29
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Change in Pain Level
timeFrame: Before and one week after the 6-session laughter yoga program
Secondary outcomes:
measure: Change in Fatigue Level
timeFrame: Before the intervention and one week after
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Study officials:
References:
citation: 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.