The Effect of Laughter Therapy on Self-Esteem and Quality of Life in Patients With Stoma
1 other identifier
interventional
66
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2021
1 active site
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
Study Start
First participant enrolled
November 6, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 6, 2021
CompletedFirst Submitted
Initial submission to the registry
October 26, 2022
CompletedFirst Posted
Study publicly available on registry
November 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2023
CompletedOctober 2, 2023
September 1, 2023
Same day
October 26, 2022
September 29, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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).
Change from baseline to 1 months
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
Change from baseline to 1 months
Secondary Outcomes (2)
City of Hope Quality of Life Ostomy
Change from baseline to 3 months
Rosenberg Self-Esteem Scale
Change from baseline to 3 months
Study Arms (2)
Experimental Group
EXPERIMENTAL1. 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.
Control Group
NO 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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,
- Having internet,
- Being able to use Whatsapp video calling program,
- Agreeing to participate in the research.
You may not qualify if:
- Hernia, prolapse of stoma complications or glaucoma disease,
- Presence of hypertension and heart disease,
- Abdominal surgery in the last 3 months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hatice Merve Alptekin
Istanbul, Sisli, 34360, Turkey (Türkiye)
Related Publications (10)
Karadag A, Ozturk D, Celik B. Adaptation of the ostomy adjustment inventory into Turkish Language. Turk J Colorectal Dis. 2011;21:173-181.
BACKGROUNDAyaz S. Body image and self-esteem in patients with stoma: Review. Turkiye Klinikleri J Med Sci. 2008; 28(2):154-159.
BACKGROUNDSatish PD. Laughter therapy. Journal of Pharmaceutical and Scientific Innovation. 2012;1(3):23-4.
BACKGROUNDFarifteh 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.
PMID: 25628838BACKGROUNDRipoll 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.
PMID: 23017490BACKGROUNDCha 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.
PMID: 37697500BACKGROUNDCho 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.
PMID: 21804337BACKGROUNDYoshikawa 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.
PMID: 30534398BACKGROUNDÇuhadaroğlu F. (1986).Adolesanlarda Benlik Saygısı, Hacettepe Üniversitesi Tıp Fakültesi, Psikiyatri Anabilim Dalı, Uzmanlık Tezi, Ankara
BACKGROUNDErol 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.
BACKGROUND
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nuray Akyüz, Associate Professor
Istanbul University - Cerrahpasa
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Assistant
Study Record Dates
First Submitted
October 26, 2022
First Posted
November 1, 2022
Study Start
November 6, 2021
Primary Completion
November 6, 2021
Study Completion
April 30, 2023
Last Updated
October 2, 2023
Record last verified: 2023-09