Effect of Laughter Therapy on Breast Cancer Patients
The Effect of Laughter Therapy on Distress, Depression and Psychological Well-being in Breast Cancer Patients Before Surgical Intervention: A Randomised Controlled Trial
1 other identifier
interventional
56
0 countries
N/A
Brief Summary
The aim of this study is to examine the effect of laughter therapy applied to breast cancer patients before surgical intervention on distress, depression and psychological well-being of patients. This research will be carried out as an experimental research with a randomised control group. The population of the study will consist of breast cancer patients diagnosed with breast cancer in a city hospital and scheduled for surgery in the breast-endocrine surgery clinic. The research will be carried out with patients who meet the inclusion criteria and agree to participate in the study. The sample size for the study was calculated using the G\* Power 3.1.9.7 programme (Faul et al., 2007). In the calculation, since there was no similar study for two-way mixed design analysis of variance, the required sample size was calculated as 48, 24 in each group, based on the medium effect size (effect size f=0.25), 5% margin of error (alpha=0.05), inter-measurement correlation value 0.5 and 80% power (1-β=0.80). Considering the data losses, the number was increased by 20% and a total of 56 patients in the intervention and control groups constituted the sample of the study. Hypothesis(es): H1: The effect of laughter therapy applied to breast cancer patients on distress over time is different in the experimental and control groups. H2: The effect of laughter therapy applied to breast cancer patients on depression over time is different in the experimental and control groups. H3: The effect of laughter therapy applied to breast cancer patients on psychological well-being according to time is different in experimental and control groups. In obtaining the research data; Personal Information Form, Distress Thermometer, Psychological well-being scale prepared by the researchers in line with the literature will be used. The research data will be collected face-to-face through data collection forms from breast cancer patients diagnosed with breast cancer and scheduled for surgery in the breast-endocrine surgery clinic. Individuals who agree to participate in the study and meet the inclusion criteria will be assigned to the experimental and control groups by providing randomisation. Which caregivers will be in the intervention group and which will be in the control group will be determined according to the randomisation table determined by https://www.randomizer.org/ over the internet. Group 1: Intervention Group, Group 2: Control Group. Data collection tools will be applied to the individuals in the experimental and control groups as a pre-test. Individuals in the experimental group will receive laughter therapy three days a week for 30-45 minutes (6 sessions). Individuals in the control group will receive only standard nursing care. Data collection tools will be applied to the individuals in both groups for post-test, 1 and 3-month follow-up tests immediately after all laughter sessions with the experimental group are completed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2025
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 25, 2025
CompletedFirst Posted
Study publicly available on registry
June 13, 2025
CompletedStudy Start
First participant enrolled
June 25, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2025
CompletedJune 13, 2025
June 1, 2025
2 months
April 25, 2025
June 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Laughter therapy will be applied to individuals with breast cancer and their levels of psychological distress will be measured.Laughter therapy will be applied to individuals with breast cancer and their psychological distress levels will be measured.
Meme kanserine sahip olan bireylere kahkaha terapisi uygulanacak ve pskilojik sıkıntı düzeyleri ölçülecektir. Laughter therapy will be applied to individuals with breast cancer and their levels of psychological distress will be measured. (Face to face training will be given)
2 weeks
Laughter therapy will be applied to individuals with breast cancer and their depression levels will be measured.
Laughter therapy will be applied to individuals with breast cancer and their depression levels will be measured (Face to face training will be given)
2 weeks
Laughter therapy will be applied to individuals with breast cancer and their psychological well-being levels will be measured.
Laughter therapy will be applied to individuals with breast cancer and their psychological well-being levels will be measured (Face to face training will be given)
2 weeks
Study Arms (2)
Experimental group
EXPERIMENTALLaughter therapy
control group
ACTIVE COMPARATORroutine nursing care
Interventions
Laughter therapy/yoga, classified as complementary therapy in medicine, is a unique form of exercise consisting of a combination of laughter, yoga and breathing techniques that allows us to laugh without any sense of humour.
Eligibility Criteria
You may qualify if:
- Voluntary acceptance to participate in the study,
- Being diagnosed with breast cancer and being in the patient group in which surgical operation is planned,
- Not having participated in laughter yoga practice before,
- Being literate,
- Not having a psychiatric disease (diagnosis)
- Not having a communication and understanding disability related to vision, hearing
- Being in the age group of 18 and over
You may not qualify if:
- Not wanting to participate in the study,
- Being in the patient group with a condition recommended not to do laughter yoga (having undergone surgery in the abdominal region in the last three months, uncontrolled hypertension, glaucoma, hernia, epilepsy),
- Not having participated in any of the laughter yoga sessions,
- Having physical restriction/respiratory problems and not being able to perform yoga movements.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Servet Cihan
Prof. Dr. Cemil Taşcıoğlu Şehir Hastanesi
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Education nurse
Study Record Dates
First Submitted
April 25, 2025
First Posted
June 13, 2025
Study Start
June 25, 2025
Primary Completion
August 30, 2025
Study Completion
October 30, 2025
Last Updated
June 13, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share