NCT05807685

Brief Summary

: Responsibility of women staying in their traditional and modern roles has increased and the difficulties experienced by women require them to struggle with many problems. As a result of these experiences, problems have arisen for women. In addition to the intensity of the home/work life of women who have children in primary school, the lesson and responsibility of the child falls on the women. In a patriarchal society, burdening all non-working women with the responsibility of their child in addition to housework increases the fatigue of mothers. Due to this intensity, they are not able to spare time for themselves and feel guilty. In women, this situation gradually causes burnout syndrome. One of the most important personal development methods used to reduce burnout is laughter therapy. The aim of this study is to apply laughter therapy in order to reduce this sense of burnout and guilt in women. Aim: In this study, it was aimed to examine the effect of laughter therapy on the feelings of burnout and guilt of women who have children at primary school age.

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
50

participants targeted

Target at P25-P50 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 11, 2023

Status Verified

March 1, 2023

Enrollment Period

2 months

First QC Date

March 29, 2023

Last Update Submit

March 29, 2023

Conditions

Keywords

laughter therapyburnoutguiltwomen

Outcome Measures

Primary Outcomes (1)

  • Expressed Guilt Scale

    The scale developed by Guerrero et al. (2009) consists of 20 items. Participants were asked to rate the extent to which each item reflected their feelings and thoughts in their relationships on a 7-point Likert scale (1 = never, 4 = sometimes, 7 = always/continuously). 4 of the items are to apologize/confess (e.g., "I tell my partner that I regret what I did (or did not do)"), 4 of them are to explain/give reason (e.g., "I tell my partner the reasons/reasons for what I did"), 7 of them measure compromising/forgiveness (eg, "I promise to be a better wife in the future") and 5 denial (eg, "I try to minimize/downplay the situation") sub-dimensions.

    one day

Secondary Outcomes (1)

  • Burnout Scale Short Form

    one day

Study Arms (2)

control group

NO INTERVENTION

At the beginning of the study, Data collection tools such as Individual Identification Form, Expressed Guilt Scale and Burnout Scale Short Version will be applied to the control group. No intervention will be made in the control group. In the post-test, the Expressed Guilt Scale and the Burnout Scale Short Version will be administered again.

experimental group

EXPERIMENTAL

Arm Title: Experimental Group: Individual Identification Form, Expressed Guilt Scale and Burnout Scale Short Version will be administered to the mothers of children studying at Sinop Atatürk Primary School in the 2022-2023 spring semester before the laughter therapy. At the end of the laughter therapy, the Expressed Guilt Scale and the Short Version of the Burnout Scale will be administered as a post-test. The Individual Identification Form, Expressed Guilt Scale and Burnout Scale Short Version will be used for all mothers of the students studying in Atatürk Primary School in the 2022-2023 academic year. All women whose Burnout Scale Short Form is above the average will be included in the study. Since all women whose Burnout Scale Short Form is above the average, who volunteered to participate in the study and who met the inclusion criteria will be included in the study, no additional sample selection will be made.

Behavioral: laughter therapy

Interventions

Description: Laughter therapy session will be applied online for 25-30 minutes once a week for 2 months by the researchers 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 group

Eligibility Criteria

Age20 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Being the mother of the child studying at Sinop Atatürk Primary School where the research will be conducted, Having a burnout scale score of 3.5 and above, Volunteer to participate in research.

You may not qualify if:

  • Not having a child studying at the Sinop Atatürk Primary School where the research will be conducted, Being the father of the child who was educated at the Sinop Atatürk Primary School, where the research will be conducted, Having a burnout scale score below 3.5, Not volunteering to participate in the research.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

LaughterBurnout, Psychological

Interventions

Laughter Therapy

Condition Hierarchy (Ancestors)

Nonverbal CommunicationCommunicationBehaviorStress, PsychologicalBehavioral Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeutics

Study Officials

  • Berna ERSOY ÖZCAN

    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
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
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 11, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share