NCT05843058

Brief Summary

The aim of the thesis is to determine the effect of laughter yoga on psychological well-being in women diagnosed with Gynecological Cancer.The population of the study consists of the patients registered in the oncology service of Tepecik Training and Research Hospital in Izmir. The study was carried out with 70 patients, 35 of which were interventions and 35 controls, who were treated in the oncology service of Izmir Tepecik Training and Research Hospital.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

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

October 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 6, 2023

Completed
Last Updated

May 6, 2023

Status Verified

April 1, 2023

Enrollment Period

6 months

First QC Date

March 30, 2023

Last Update Submit

May 3, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Psychological well-being scale (PWS)

    Change in Psychological well-being scale (PWS); is a 7-point Likert type scale ranging from strongly disagree (1) to strongly agree (7). All items are expressed positively. The lowest score is 8 and the highest score is 56. A high score indicates that the individual has many psychological resources and strengths. The effect of laughter yoga on psychologıcal wellness.

    6 months

Study Arms (2)

laughter yoga

EXPERIMENTAL

The psychological well-being scale was filled in at the first encounter with the patient. Then, 12 sessions of laughter yoga were performed and after 12 sessions, the psychological well-being scale was applied again.(Laughter yoga was practiced twice a week for 6 weeks)

Behavioral: laughter yoga

Standard care

NO INTERVENTION

The psychological well-being scale was filled in at the first encounter with the patient. Then, 6 weeks later, the psychological well-being scale was applied again.

Interventions

laughter yogaBEHAVIORAL

The effect of laughter yoga on psychologıcal wellness ın women wıth gynecologıcal cancer has been evaluated.

laughter yoga

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWOMEN WITH GYNECOLOGICAL CANCER
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Volunteering to participate in the study
  • Having the ability to read, write, speak and understand Turkish
  • Being diagnosed with gynecological cancer
  • Being in Stage II or Stage III of the gynecological cancer staging processes
  • The patient's internet access

You may not qualify if:

  • The patient is Stage 4
  • Lack of internet access

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kerime Derya BEYDAG

Istanbul, 34104, Turkey (Türkiye)

Location

Related Publications (6)

  • Bennett PN, Hussein WF, Reiterman M, Yu J, Schiller B. The effects of laughter therapy on depression symptoms in patients undergoing center hemodialysis: A pragmatic randomized controlled trial. Hemodial Int. 2020 Oct;24(4):541-549. doi: 10.1111/hdi.12870. Epub 2020 Aug 25.

    PMID: 32844575BACKGROUND
  • 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
  • Demir Dogan M. The Effect of Laughter Therapy on Anxiety: A Meta-analysis. Holist Nurs Pract. 2020 Jan/Feb;34(1):35-39. doi: 10.1097/HNP.0000000000000363.

    PMID: 31725098BACKGROUND
  • Ghodsbin F, Sharif Ahmadi Z, Jahanbin I, Sharif F. The effects of laughter therapy on general health of elderly people referring to jahandidegan community center in shiraz, iran, 2014: a randomized controlled trial. Int J Community Based Nurs Midwifery. 2015 Jan;3(1):31-8.

    PMID: 25553332BACKGROUND
  • Hatzipapas I, Visser MJ, Janse van Rensburg E. Laughter therapy as an intervention to promote psychological well-being of volunteer community care workers working with HIV-affected families. SAHARA J. 2017 Dec;14(1):202-212. doi: 10.1080/17290376.2017.1402696.

    PMID: 29169302BACKGROUND
  • Kim SH, Kim YH, Kim HJ. Laughter and Stress Relief in Cancer Patients: A Pilot Study. Evid Based Complement Alternat Med. 2015;2015:864739. doi: 10.1155/2015/864739. Epub 2015 May 24.

    PMID: 26064177BACKGROUND

MeSH Terms

Conditions

Laughter

Interventions

Laughter Therapy

Condition Hierarchy (Ancestors)

Nonverbal CommunicationCommunicationBehavior

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeutics

Study Officials

  • Kerime Derya BEYDAG

    https://akademik.yok.gov.tr/AkademikArama/view/viewAuthor.jsp

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

March 30, 2023

First Posted

May 6, 2023

Study Start

October 1, 2021

Primary Completion

April 1, 2022

Study Completion

April 1, 2022

Last Updated

May 6, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations