- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06654869
Laughter Yoga Effect on Cancer Patients' Physiopsychological Symptoms
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
Sample Size Calculation:
The sample size was calculated using G*Power (version 3.1.9.7). Based on ANCOVA test (fixed effects, main effects and interactions), a large effect size (Cohen's f=0.40) was assumed based on previous laughter yoga literature in oncology patients (Moon et al., 2024; Mayers 2013; Faul et al, 2007). With an alpha level of 0.05 and a power of 0.80 (for two groups and one covariate), the minimum required sample size was determined to be 48 participants. To compensate for a potential attrition rate, 60 patients were initially recruited for the study. Inclusion criteria: (1) age ≥18, (2) pathologically confirmed cancer diagnosis, (3) be able to communicate, and (4) voluntary participation. Exclusion criteria: (1) psychiatric disorder, (2) treatments other than chemotherapy, (3) severe psychiatric illness, (4) hearing or vision loss, (5) prior laughter therapy experience, or (6) unstable clinical condition. Discontinuation Criteria: (1) withdrawal request, (2) worsening of clinical condition, (3) change in treatment protocol.Due to the nature of the laughter yoga intervention, participants and the first author (who performed the sessions) could not be blinded. After baseline assessments, 60 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). 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. However, to minimize bias, data analysis was conducted by an independent statistician who remained blinded to the group assignments throughout the study. Of the initial 60 participants, five patients (three from the intervention group and two from the control group) were excluded after randomization due to changes in their medical treatment protocols. The study was completed with 55 patients (27 intervention, 28 control). A per-protocol analysis was performed, including only those participants who completed the designated intervention sessions and follow-up assessments.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Yakutiye
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Erzurum, Yakutiye, Turkey (Türkiye), 25080
- Atatürk Üniversitesi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion criteria: (1) age ≥18, (2) pathologically confirmed cancer diagnosis, (3) be able to communicate, and (4) voluntary participation.
Exclusion criteria: (1) psychiatric disorder, (2) treatments other than chemotherapy, (3) severe psychiatric illness, (4) hearing or vision loss, (5) prior laughter therapy experience, or (6) unstable clinical condition.
Discontinuation Criteria: (1) withdrawal request, (2) worsening of clinical condition, (3) change in treatment protocol.
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 |
|---|---|
|
No Intervention: Arm 2
|
|
|
Experimental: Arm 1
laughter yoga
|
include laughter yoga effects on cancer patients' symptom management
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Edmonton Symptom Assesment Scale (ESAS)
Time Frame: 4 weeks
|
Bruera et al. (1991) to evaluate nine symptoms commonly seen in cancer patients.
These symptoms are pain, fatigue, nausea, sadness, anxiety, insomnia, loss of appetite, feeling good, shortness of breath and other problems.
In the other problems section of the scale, 2 additional symptoms seen in patients by researchers (feeling of thirst and discomfort due to catheters and catheters) were added in accordance with literature information.
The severity of each symptom is evaluated with numerical numbers from 0 to 10.
A score of 0 indicates that there is no symptom, a score of 10 indicates that the symptom is felt very severely, and the severity of the symptom increases from 0 to 10.
|
4 weeks
|
|
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.
|
4 weeks
|
|
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.
|
4 weeks
|
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.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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