Effects of Laughter Yoga on Symptom Severity, Hope, and Life Engagement in Patients Undergoing Chemotherapy; A Randomized Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The sample size was determined through an a priori power analysis using G*Power software (version 3.1.2). The test family was "t tests" and the statistical test was "Means: Difference between two independent means (two groups)". Based on Cohen's standard effect size references it was determined that a total of 52 participants (26 per group) would be sufficient to achieve 80% power with a large effect size (two-tailed, Cohen's d = 0.80, α = 0.05). The choice of a large effect size was justified by recent evidence from laughter interventions in cancer. To account for a potential 15% attrition rate, 8 additional participants were included, resulting in a total sample size of 60 individuals. Following the completion of the study, the effect sizes for each variable were reported in their respective tables. Inclusion criteria: (1) age ≥18, (2) pathologically confirmed cancer diagnosis, (3) be able to communicate, and (4) voluntary participation. Exclusion criteria: (1) diagnosed psychiatric disorders that may interfere with study participation or communication, (2) receiving medical treatments other than chemotherapy, (3) significant hearing or vision loss, (4) prior experience with laughter therapy, or (5) an unstable clinical condition. Discontinuation Criteria: (1) withdrawal request, (2) worsening of clinical condition, (3) change in treatment protocol.
A list of eligible patients was provided by the unit charge nurse. Of the 87 assessed, 24 patients did not meet inclusion criteria and 3 patients declined participation. Due to the nature of the laughter yoga intervention, participants and the first author (who performed the sessions) could not be blinded. After obtaining voluntary consent, eligible patients were randomized into intervention (n=30) and control (n=30) groups with a 1:1 allocation ratio using a computer-generated random number list (randomizer.org). To ensure allocation concealment, randomization was managed by an independent researcher who did not recruit patients or perform the sessions. Once a patient was enrolled, the independent researcher provided the group assignment to the first researcher. This centralized approach prevented the first researcher from knowing the sequence in advance, thereby reducing potential selection bias. Immediately following randomization, but prior to the collection of pre-test and the commencement of the intervention, five patients (3 from the intervention group and 2 from the control group) were excluded due to unforeseen changes in their medical treatment protocols. Since these individuals left the study before any baseline or post-test assessments could be conducted, their data were unavailable for inclusion. Consequently, a per-protocol analysis was performed with the remaining 55 patients (27 intervention, 28 control) who completed the trial. To minimize bias, data analysis was conducted by an independent statistician who remained blinded to the group assignments throughout the study.
Explanation regarding protocol improvements: Initial registration reflected the study plan at the time of registration. Before enrollment of the first participant, certain methodological and operational details were further refined based on the clinical setting, characteristics of the appropriate patient population, discussions with the clinical team, and a review of the relevant literature. These refinements included a more detailed definition of the intervention duration, the randomization procedure, and the eligibility criteria. Final procedures were determined prior to the enrollment of the first participant on January 30, 2025, and were consistently applied throughout the study.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Yakutiye
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Erzurum, Yakutiye, Turkey (Türkiye), 25080
- Atatürk Üniversitesi
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Arm 2
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Experimental: Arm 1
laughter yoga
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include laughter yoga effects on cancer patients' symptom management
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Life Engagement Scale
Time Frame: 4 weeks
|
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.
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4 weeks
|
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Herth Hope Scale
Time Frame: 4 weeks
|
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.
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4 weeks
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Edmonton Symptom Assesment Scale (ESAS)
Time Frame: 4 weeks
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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.
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4 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ATATURKU-NRS-YCY-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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