NCT05601024

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 6, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 6, 2021

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

October 26, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

October 2, 2023

Status Verified

September 1, 2023

Enrollment Period

Same day

First QC Date

October 26, 2022

Last Update Submit

September 29, 2023

Conditions

Keywords

Laughter TherapyQuality of LifeSelf EsteemStoma

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

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.

Behavioral: Laughter Therapy

Control Group

NO INTERVENTION

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. 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.

Experimental Group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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)

Location

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.

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

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

    BACKGROUND
  • 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.

    PMID: 25628838BACKGROUND
  • 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.

    PMID: 23017490BACKGROUND
  • 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.

    PMID: 37697500BACKGROUND
  • 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.

    PMID: 21804337BACKGROUND
  • 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.

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

    BACKGROUND
  • 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.

    BACKGROUND

Related Links

MeSH Terms

Interventions

Laughter Therapy

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeutics

Study Officials

  • Nuray Akyüz, Associate Professor

    Istanbul University - Cerrahpasa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Randomized controlled experimental design
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

Locations