NCT07020962

Effect of Laughter Therapy on Breast Cancer Patients

Not yet recruiting NA Last updated 13 June 2025

What this trial tests

NA trial testing laughter therapy in Laughter Therapy in 56 participants. Not yet recruiting.

Timeline

25 June 2025

Primary endpoint
30 August 2025

30 October 2025

Quick facts

Lead sponsor	Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	supportive care
Enrollment	56
Start date	25 June 2025
Primary completion	30 August 2025
Estimated completion	30 October 2025

Drugs / interventions tested

• laughter therapy
• routine nursing care

Conditions studied

• Laughter Therapy — all drugs for Laughter Therapy →
• Psychological Well-being — all drugs for Psychological Well-being →
• Breast Cancer — all drugs for Breast Cancer →
• Distress — all drugs for Distress →

Sponsor

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Who can join

Adults 18 to 100, any sex, with Laughter Therapy or Psychological Well-being. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.