NCT05933915

Brief Summary

Aim: The aim of this study is to determine the effect of laughter yoga, which includes various relaxing practices, on secondary trauma levels and psychological well-being of midwives. The study was planned as a randomized controlled experimental study. This RCT will be administered following the CONSORT 2010 guidelines. Material and Methods: Considering the case losses in the study, it was planned to create a total of 80 midwives, 40 in the intervention group and 40 in the control group. Laughter yoga will be practiced in the intervention group. No intervention will be made on the control group. Data were collected by using the Personal Information Form, Secondary Traumatic Stress Scale, Psychological Well-Being Scale.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

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

June 24, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 6, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

July 6, 2023

Status Verified

July 1, 2023

Enrollment Period

6 months

First QC Date

June 24, 2023

Last Update Submit

July 3, 2023

Conditions

Keywords

laughyogasecondary traumapsychological well-being

Outcome Measures

Primary Outcomes (3)

  • Introductory Information Form

    In this form, which was created by the researchers based on the literature, the participants' age, the high school they graduated from, their willingness to choose the profession, their feeling of belonging to the profession, the unit they work in, their working status in crisis situations, etc. questions are included.

    Before application

  • Psychological Well-Being Scale

    The scale was developed to measure current socio-psychological well-being. Scores that can be obtained from the scale range from 8 (if strongly disagree with all items) to 56 (if strongly agree with all items). It is concluded that individuals with high scores have high psychological resources.

    Before application

  • Secondary Traumatic Stress Scale

    The scale consists of 17 items and is scored with a 5-point Likert-type rating (1=Never, 5=Very often). The scale has three sub-dimensions: emotional violation, avoidance and arousal. Items numbered 2,3,6,10,13 evaluate emotional violation sub-dimension; items numbered 1,5,7,9,12,14,17 evaluate avoidance sub-dimension; items numbered 4,8,11,15,16 evaluate arousal sub-dimension. The score that can be obtained from the scale is between 17 and 85 and the increase in the score indicates a high level of affectivity.

    Before application

Secondary Outcomes (2)

  • Secondary Traumatic Stress Scale

    4-6 weeks after application

  • Psychological Well-Being Scale

    4-6 weeks after application

Study Arms (2)

Intervention Group (Laughter yoga group) (n:40)

EXPERIMENTAL

Laughter yoga will be practiced to midwives in the intervention group.

Other: group-based laughter yoga

Control Group (n:40)

NO INTERVENTION

The control group will not be subjected to any application.

Interventions

Midwives in the intervention group of the research will apply 8 sessions of laughter yoga, 2 sessions a week. Laughter yoga will be practiced by researchers with leadership certification. Each session will take an average of 45 minutes. Laughter Yoga sessions will be held on the web through the "Zoom" program. Each session will consist of groups of 8 people.

Intervention Group (Laughter yoga group) (n:40)

Eligibility Criteria

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

You may qualify if:

  • Being a midwifery graduate and working actively in the field
  • Volunteering to participate in the research

You may not qualify if:

  • Any psychiatric diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

LaughterCompassion FatiguePsychological Well-Being

Condition Hierarchy (Ancestors)

Nonverbal CommunicationCommunicationBehaviorMental FatigueFatigueSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsOccupational StressStress, PsychologicalPersonal Satisfaction

Study Officials

  • Yasemin Aydın Kartal Assoc. Prof. Dr.

    Saglik Bilimleri Universitesi

    PRINCIPAL INVESTIGATOR
  • Aleyna Bulut Research Assistant

    Saglik Bilimleri Universitesi

    STUDY CHAIR
  • Sema Aker Research Assistant

    Saglik Bilimleri Universitesi

    STUDY CHAIR

Central Study Contacts

Yasemin Aydın Kartal Assoc. Prof. Dr.

CONTACT

Aleyna Bulut Research Assistant

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Single blind randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. Dr.

Study Record Dates

First Submitted

June 24, 2023

First Posted

July 6, 2023

Study Start

September 1, 2023

Primary Completion

March 1, 2024

Study Completion

August 1, 2024

Last Updated

July 6, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations