Effects of Laughter Yoga on Symptom Severity, Hope, and Life Engagement in Patients Undergoing Chemotherapy; A Randomized Controlled Study
1 other identifier
interventional
60
1 country
1
Brief Summary
Non-pharmacological interventions that promote positive emotional states and coping may play a critical role in care of cancer patients undergoing chemotherapy.This study aimed to evaluate the effects of laughter yoga on symptoms, hope, and life engagement levels in cancer patients undergoing chemotherapy. Conducted between January and June 2025 at the chemotherapy unit of Atatürk University Research Hospital in Türkiye. . Sixty patients were randomized (30 per group). Five were excluded after randomization before baseline assessment because of changes in medical treatment, leaving 55 participants in the per-protocol analysis (intervention n= 27; control n= 28). Symptom severity, hope, and life engagement were measured at baseline and after four weeks using the Edmonton Symptom Assessment Scale (ESAS), Herth Hope Scale (HHS), and Life Engagement Scale (LES). Post-intervention analyses revealed statistically significant improvements in the intervention group compared to the control group. Patients who received laughter yoga reported significantly lower symptom severity on the ESAS (p \< 0.05), along with significantly higher levels of hope and life engagement as measured by the HHS and LES, respectively (p \< 0.05).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable cancer
Started Jan 2025
Shorter than P25 for not_applicable cancer
1 active site
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
September 26, 2024
CompletedFirst Posted
Study publicly available on registry
October 23, 2024
CompletedStudy Start
First participant enrolled
January 30, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 15, 2025
CompletedAugust 26, 2026
August 1, 2026
5 months
September 26, 2024
August 24, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
Edmonton Symptom Assesment Scale (ESAS)
The scale, originally developed by Bruera et al. (1991) to assess nine common symptoms in cancer patients: pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, well-being, and shortness of breath. For this study, the Turkish version validated by Sadırlı and Ünsar (2009) was utilized, which includes three additional symptoms-changes in skin and nails, mouth sores, and numbness in the hands-resulting in a 12-item scale. Each symptom is rated on a numerical scale from 0 "symptom absent" to 10 "worst possible severity". In the Turkish validation study, Cronbach's alpha coefficients were reported as 0.83 for the pre-test and 0.76 for the post-test. In the present study, the Cronbach's alpha coefficients for the scale were calculated as 0.71 and 0.72 for the pre-test and post-test, respectively.
4 weeks
Life Engagement Scale
The Life Engagement scale, developed by Scheier et al. (2006) to assess individuals' life goals and whose Turkish validity and reliability were determined by Akın et al., is a measurement tool consisting of 6 items and a single dimension (life engagement). The scale has a 5-point scale ("1" I completely disagree, "5" I completely agree). Items 1, 3 and 5 are reverse coded in the scale. Increasing scores indicate a high level of life engagement.
4 weeks
Herth Hope Scale
The Herth Hope Scale was developed by Kaye Herth. The scale consists of 30 items. Each item has four options: "Never " "Rarely appropriate," "Sometimes" and "Always " . The corresponding scores are 0, 1, 2, and 3, respectively. The respondent is asked to mark a single option for each item. The scale consists of 3 sub-dimensions. These are "Future," "Positive Readiness and Expectation," and "Relationships Between Oneself and Those Around Oneself." The "Future" sub-dimension measures the cognitive-temporal dimension of hope, the "Positive Readiness and Expectation" sub-dimension measures the emotional-behavioral dimension of hope, and the "Relationships Between Oneself and Those Around Oneself" sub-dimension measures the dimension of hope related to relationships and the conditions in which it exists. The total hope score varies between 0-90, and the total score of each subscale varies between 0-30. High scores, It shows that hope is high.
4 weeks
Study Arms (2)
Arm 2
NO INTERVENTIONArm 1
EXPERIMENTALlaughter yoga
Interventions
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Atatürk Üniversitesi
Erzurum, Yakutiye, 25080, Turkey (Türkiye)
MeSH Terms
Conditions
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Allocation concealment was ensured by an independent external researcher who held the randomization list and was not involved in patient recruitment or intervention thus ensuring that the researchers remained blinded to the group assignments during the initial evaluation.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 26, 2024
First Posted
October 23, 2024
Study Start
January 30, 2025
Primary Completion
June 30, 2025
Study Completion
August 15, 2025
Last Updated
August 26, 2026
Record last verified: 2026-08