NCT05807698

Brief Summary

Brief Summary: The definition of individuals with disabilities, who are among the disadvantaged group, is defined by Law No. 5378 as "those who have difficulties in adapting to social life and meeting their daily needs due to the loss of their physical, mental, spiritual, sensory and social abilities at various degrees due to any congenital or subsequent reason; and a person who needs protection, care, rehabilitation, counseling and support services" (Law on the Disabled). Due to the fact that the conditions and needs of physically disabled women are not well expressed, they have not benefited enough from services such as education and health and they have faced difficulties. No study has been found in the world or in our country that examines the effect of laughter yoga on physically disabled women and their relatives. In this study, it is thought that the practice of laughter yoga can increase the psychological well-being and quality of life of physically disabled women and their relatives. Aim: This study was planned to measure the effect of laughter yoga on psychological well-being and quality of life in physically disabled women and their relatives.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Status
unknown

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

First Submitted

Initial submission to the registry

March 29, 2023

Completed
12 days until next milestone

Study Start

First participant enrolled

April 10, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 11, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2023

Completed
Last Updated

April 12, 2023

Status Verified

April 1, 2023

Enrollment Period

2 months

First QC Date

March 29, 2023

Last Update Submit

April 11, 2023

Conditions

Keywords

laughter therapypsychological well beingquality of lifePhysically Disabled Women

Outcome Measures

Primary Outcomes (1)

  • Psychological Well-Being Scale

    It was developed by Diener et al., (2010) and adapted into Turkish by Telef (2013). It is a single factor, 7-point Likert scale consisting of 8 items. The range of scores obtained varies between 8 and 56. A high score from the scale indicates that the individual is psychologically strong.

    one day

Secondary Outcomes (1)

  • SF-12 Quality of Life Scale Short Form

    one day

Study Arms (1)

experimental

EXPERIMENTAL

Assigned Interventions Laughter therapy session will be applied online for 25-30 minutes once a week for 2 months by the researcher who has the Laughter therapy certificate to the application group. In the laughter therapy session, the practices of introducing the practitioner and introducing the therapy, breathing exercises for a healthy life, keeping the rhythm accompanied by music, turning the laughter that started as if it were childlike games into reality will be carried out.

Behavioral: laughter therapy

Interventions

Assigned Interventions Laughter therapy session will be applied online for 25-30 minutes once a week for 2 months by the researcher who has the Laughter therapy certificate to the application group. In the laughter therapy session, the practices of introducing the practitioner and introducing the therapy, breathing exercises for a healthy life, keeping the rhythm accompanied by music, turning the laughter that started as if it were childlike games into reality will be carried out.

experimental

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being between the ages of 18-65,
  • Being woman,
  • Not being mentally handicapped
  • Having a physical disability
  • Being a relative caring for a woman with a physical disability.

You may not qualify if:

  • Not being between the ages of 18-65,
  • To being male,
  • Being mentally handicapped
  • Not having a physical disability
  • Not volunteering to participate in the research.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

LaughterPsychological Well-Being

Interventions

Laughter Therapy

Condition Hierarchy (Ancestors)

Nonverbal CommunicationCommunicationBehaviorPersonal Satisfaction

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeutics

Study Officials

  • Berna ERSOY ÖZCAN, PhD

    Sinop University

    PRINCIPAL INVESTIGATOR
  • Yasemin ÖZYER, PhD

    Sinop University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Berna ERSOY ÖZCAN, PhD

CONTACT

Meryem ERDOĞAN, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2023

First Posted

April 11, 2023

Study Start

April 10, 2023

Primary Completion

June 10, 2023

Study Completion

August 10, 2023

Last Updated

April 12, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share