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Stoma ColostomyNCT05601024

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

A study testing Laughter Therapy in people with Stoma Colostomy and Stoma Ileostomy, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Stoma is a surgical intervention to ensure that body wastes are removed differently from the normal physiological opening. The stoma patient has to cope with complex emotional, social and physical problems associated with this change. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Stoma Colostomy, Stoma Ileostomy
What is being tested?
Laughter Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteTurkey (Türkiye)
Study dates
6 Nov 2021to 30 Apr 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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,
  • Having a smart phone or computer,
  • Being able to use a smart phone or computer,
Show all 9Show fewer
  • Having internet,
  • Being able to use Whatsapp video calling program,
  • Agreeing to participate in the research.

Who cannot join

  • Hernia, prolapse of stoma complications or glaucoma disease,
  • Presence of hypertension and heart disease,
  • Abdominal surgery in the last 3 months.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Hatice Merve Alptekin

    Istanbul, Sisli, 34360

Other trials in Turkey (Türkiye)

About this study

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

Stoma is a surgical intervention to ensure that body wastes are removed differently from the normal physiological opening. The stoma patient has to cope with complex emotional, social and physical problems associated with this change. Physical health problems (such as stoma), change in body image and negative emotions affect self-esteem and quality of life. Laughing provides mental and physical relaxation with the release of endorphins. Therefore, laughter therapy has an important contribution to increase the well-being of patients.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.

Read the detailed description

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.
Being tested
Laughter Therapy
Keywords
Laughter Therapy, Quality of Life, Self Esteem, Stoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Laughter TherapyBehavioural

    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. Participants will do laughter therapy with whatsapp group call. 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.

Study groups in NCT05601024
Study groupRoleWhat they receive
Experimental GroupExperimental1. 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.
Receives: Behavioral: Laughter Therapy
Control GroupNo intervention1. 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. After 2 weeks: Patients will be called by phone and asked if they have any complaints about their disease. 3. 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. City of Hope Quality of Life Ostomy

    This scale, which evaluates the quality of life, consists of 43 items. In this scale, quality of life items are grouped into four sub-dimensions: physical well-being (1-11 items), psychological well-being (12-24 items), social anxiety (25-36 items) and spiritual well-being (37-43 items).

    Measured: Change from baseline to 1 months

  2. Rosenberg Self-Esteem Scale

    This scale consists of 10 questions that measure self-esteem. If the total score from 10 questions is 0-1, it indicates high self-esteem, 2-4 indicates medium, and 5-6 indicates low self-esteem. The highest score that can be obtained from the scale is 6

    Measured: Change from baseline to 1 months

Secondary outcomes (2)
  1. City of Hope Quality of Life Ostomy

    Changes in patients' longer-term quality of life will be assessed after laughter therapy.

    Measured: Change from baseline to 3 months

  2. Rosenberg Self-Esteem Scale

    Changes in patients' longer-term self-esteem will be assessed after laughter therapy.

    Measured: Change from baseline to 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2022
  2. Study start6 Nov 2021
  3. Primary completion6 Nov 2021
  4. Study completion30 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized controlled experimental design
Masking
None (open label)
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05601024
Sponsor's protocol ID
E-74555795-050.01.04-97020
Status last verified
Sep 2023
First submitted
26 Oct 2022
Last updated
2 Oct 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Karadag A, Ozturk D, Celik B. Adaptation of the ostomy adjustment inventory into Turkish Language. Turk J Colorectal Dis. 2011;21:173-181.

  • Ayaz S. Body image and self-esteem in patients with stoma: Review. Turkiye Klinikleri J Med Sci. 2008; 28(2):154-159.

  • Satish PD. Laughter therapy. Journal of Pharmaceutical and Scientific Innovation. 2012;1(3):23-4.

  • Farifteh S, Mohammadi-Aria A, Kiamanesh A, Mofid B. The Impact of Laughter Yoga on the Stress of Cancer Patients before Chemotherapy. Iran J Cancer Prev. 2014 Fall;7(4):179-83.

    PubMed 25628838
  • Ripoll RM, Casado IQ. Laughter and positive therapies: modern approach and practical use in medicine. Rev Psiquiatr Salud Ment. 2010 Jan;3(1):27-34. doi: 10.1016/S1888-9891(10)70006-9. Epub 2010 Apr 14. English, Spanish.

    PubMed 23017490
  • Cha MY, Na YK, Hong HS. An Effect of Optimism, Self-esteem and Depression on Laughter Therapy of Menopausal Women. Korean J Women Health Nurs. 2012 Dec;18(4):248-256. doi: 10.4069/kjwhn.2012.18.4.248. Epub 2012 Dec 31.

    PubMed 37697500
  • Cho EA, Oh HE. [Effects of laughter therapy on depression, quality of life, resilience and immune responses in breast cancer survivors]. J Korean Acad Nurs. 2011 Jun;41(3):285-93. doi: 10.4040/jkan.2011.41.3.285. Korean.

    PubMed 21804337
  • Yoshikawa Y, Ohmaki E, Kawahata H, Maekawa Y, Ogihara T, Morishita R, Aoki M. Beneficial effect of laughter therapy on physiological and psychological function in elders. Nurs Open. 2018 Jul 18;6(1):93-99. doi: 10.1002/nop2.190. eCollection 2019 Jan.

    PubMed 30534398
  • Çuhadaroğlu F. (1986).Adolesanlarda Benlik Saygısı, Hacettepe Üniversitesi Tıp Fakültesi, Psikiyatri Anabilim Dalı, Uzmanlık Tezi, Ankara

  • Erol F, Vural F. Validity and reliability of the city of hope quality of life ostomy -scale forthe Turkish patients with ostomy. Hemşirelikte Araştırma Geliştirme Dergisi. 2012;3.

Questions about this trial

What is this clinical trial studying?

A study testing Laughter Therapy in people with Stoma Colostomy and Stoma Ileostomy, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

City of Hope Quality of Life Ostomy (time frame: Change from baseline to 1 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05601024, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2023; AzTrials last refreshed its copy on 6 Nov 2026.

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