Completed

The Effect of Laughter Therapy on Self-Esteem and Quality of Life in Patients With Stoma:Randomized Controlled Trial

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Laughter Therapy

Behavioral
Who is being recruted

From 18 to 85 Years
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Services Research Study

Interventional
Study Start: November 2021
See protocol details

Summary

Principal SponsorIstanbul University - Cerrahpasa
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 6, 2021

Actual date on which the first participant was enrolled.

The total number of individuals with a stoma is thought to be between 725,000 and 1 million (Faqs, 2020). Stoma can cause many physical, social, cognitive and emotional problems in an individual's life. These problems can negatively affect the quality of life of patients with stoma (Karadag et al. 2011). Self-esteem is an individual's positive or negative evaluation of himself/herself (Ayaz, 2008). This evaluation stems not from the individual's need to feel perfect, but from the need to accept himself and be accepted by others. Physical health problems, changes in body image and negative emotions affect self-esteem. Laughter is generally considered to be a visual expression of happiness or a feeling of joy, and it occurs with stimuli such as hearing a joke or being tickled. Neurophysiology has shown that laughter is associated with the activation of the lower middle frontal lobe cortex, which produces endorphins (Satish 2012). Laughing provides mental and physical relaxation with the release of endorphins (Farifteh et al. 2014). Psychological benefits of laughing; * Decreases symptoms of depression, anxiety and stress level. * Increases self-confidence, hope, energy and strength. * Increases memory, creative thinking and problem solving ability. * Increases interpersonal relationship and social interaction. * Collaboration enhances group identity and solidarity. * Strengthens the relationship between the health personnel and the patient. * Provides psychological well-being. * Increases joy and it's mostly contagious (Ripoll and Casado 2010). It was found to increase optimism and self-esteem in a study of menopausal women (Cha et al. 2013). As a result of Cho and Oh's (2011) study, it was stated that laughter therapy can be an effective nursing intervention applied to increase the quality of life and recovery in individuals with breast cancer. Although laughing therapy was applied in different patient groups and its positive effects were proven, a study on patients who had undergone surgical intervention could not be reached. This study was planned as a randomized controlled experimental study to evaluate the effect of laughter therapy on self-esteem and quality of life in patients with stoma. Study Population and Sampling: In the study, in calculating the sample size to be used to measure the effect of laughter therapy on self-esteem and quality of life in patients with stoma, the d value was determined as d = 0.66, α = 0.05 (margin of error), 1-β = 0.95 (power) in the light of academic studies. With the help of the G-power (version 3.1) package program, the number of samples to be included in the study was calculated as 68 people (Yoshikawa et al. 2019). Considering a possible 10% loss in the study, it was decided to include a total of 74 participants, 37 participants in each group. Randomization: The research was conducted as an open-label, blinded, randomized and controlled experimental study. A simple computer-assisted randomization method was used to distribute the groups homogeneously. For this purpose, 74 sets were created using the functions available on the "https://www.random.org/integer-sets" website. In each of these sets, there were a total of 8 participants: 4 participants from the experimental group and 4 participants from the control group. The 74 sets created as the next process were shown with 1 number each. "RANDBETWEEN" function was used in Excel. Thus, 10 numbers between 1 and 74 were generated and 10 sets to be used in randomization were randomly determined. 72 patients were randomized in the first 9 sets and 2 patients in the 10th set. Data Collection Method: Data will be collected by the researcher by calling the participants by phone. WhatsApp video chat method will be applied for the individuals in the experimental group. Data Collection Tools: 1. Personal information form (sociodemographic characteristics): With this form, which was prepared by the researcher in line with the literature, it is planned to obtain information about the sociodemographic characteristics (gender, age, occupation, etc.) and stoma (diagnosis, stoma type, etc.) of the participants. 2. Rosenberg Self-Esteem Scale: Rosenberg Self-Esteem Scale was developed by Morris Rosenberg in 1965. In 1985, The validity and reliability study of the scale, which was translated into Turkish by Dr. Füsun Çetin Çuhadaroğlu, was also conducted by Çuhadaroğlu (Çuhadaroğlu, 1986). This scale consists of 10 questions that measure self-esteem. IThe highest score that can be obtained from the scale is 6. 3. City of Hope Quality of Life Ostomy: The scale was developed by the Hope Center Pain and Palliative Care Research Center in 1995 to evaluate the quality of life of cancer patients. It is a 43-item Likert-type scale revised for individuals with ostomy. The Turkish adaptation and validity-reliability study of the scale was carried out by Erol and Vural (2012). Intervention: The first component of intervention is the laughter therapy that is a combination of warm up exercise, deep breathing exercises, childlike playfulness and laughter exercises. Hand clapping and warm-up exercises: Hands are kept parallel to each other and clapped so that the fingertips touch each other. In order to synchronize the group and increase the energy level of the group, rhythms such as ho-ho, ha-ha-ha are usually added to the clapping. Deep breathing exercises: Deep breathing exercises are exercises for filling and emptying the lungs, providing physical and mental relaxation. It is applied by breathing through the nose and exhaling slowly through the mouth. Childlike acting: One of the purposes of the laughing exercises is that childlike acting comes to life in the mind and helps to laugh. During this exercise, songs can be sung, games can be played, and laughing can be helped with music. Laughter exercises: yogic laugh exercises (Lion laugh), cheerful laugh exercises (milkshake, hot soup laugh) and physical laughter exercises. Participants will do laughter therapy with whatsapp group call. It is important for participants to share their images and voices in order to make eye contact and hear the sounds of laughter. Each group will consist of at least 5 people. Each session of laughter therapy will be offered one a weekly and 30-40 minutes each time. Experimental Group * After obtaining permission from the participants, patients will be called by phone and questions will be asked about Rosenberg Self-Esteem Scale, sociodemographic characteristics, City of Hope Quality of Life Ostomy. * Participants in this group will receive a 4 week of laughter therapy. Laughter therapy will be conducted on whatsapp. * After laughter therapy (after 1 month): Patients will be called again by phone to ask questions about the Rosenberg Self-Esteem Scale and City of Hope Quality of Life Ostomy. * After 3 month: Patients will be called again by phone to ask questions about the Rosenberg Self-Esteem Scale and City of Hope Quality of Life Ostomy. Control Group * After obtaining permission from the participants, patients will be called by phone and questions will be asked about Rosenberg Self-Esteem Scale, sociodemographic characteristics, City of Hope Quality of Life Ostomy. * After 2 weeks: Patients will be called by phone and asked if they have any complaints about their disease. * After 1 month: Patients will be called again by phone to ask questions about the Rosenberg Self-Esteem Scale and City of Hope Quality of Life Ostomy. * After 3 month: Patients will be called again by phone to ask questions about the Rosenberg Self-Esteem Scale and City of Hope Quality of Life Ostomy.

Official TitleThe Effect of Laughter Therapy on Self-Esteem and Quality of Life in Patients With Stoma:Randomized Controlled Trial
NCT05601024
Principal SponsorIstanbul University - Cerrahpasa
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

66 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Services Research Study

These studies look at how healthcare is delivered, managed, and organized. They aim to improve care quality, patient experience, and access to treatment.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 85 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

9 inclusion criteria required to participate
Being over 18 years old,

Being able to understand and speak Turkish,

Stoma has been opened at least 6 months ago,

To have completed oncological treatments,

Show More Criteria

3 exclusion criteria prevent from participating
Hernia, prolapse of stoma complications or glaucoma disease,

Presence of hypertension and heart disease,

Abdominal surgery in the last 3 months.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
1. After obtaining permission from the participants, patients will be called by phone and questions will be asked about Rosenberg Self-Esteem Scale, sociodemographic characteristics, City of Hope Quality of Life Ostomy. 2. Participants in this group will receive a 4 week of laughter therapy. Laughter therapy will be conducted on whatsapp. 3. After laughter therapy (after 1 month): Patients will be called again by phone to ask questions about the Rosenberg Self-Esteem Scale and City of Hope Quality of Life Ostomy. 4. After 3 month: Patients will be called again by phone to ask questions about the Rosenberg Self-Esteem Scale and City of Hope Quality of Life Ostomy.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Hatice Merve Alptekin

Istanbul, Turkey (Türkiye)Open Hatice Merve Alptekin in Google Maps
CompletedOne Study Center
The Effect of Laughter Therapy on Self-Esteem and Quality of Life in Patients With Stoma:Randomized Controlled Trial | PatLynk