NCT05005546

Brief Summary

Objective: The study will carried out in a randomized controlled trial to determine the effect of yoga and laughter yoga on increasing the psychological resilience of mothers with their babies in the Neonatal Intensive Care Unit Method: The research will be carried out with mothers whose babies are treated in the neonatal intensive care unit. Mothers will be divided into three groups as yoga (n=20), laughter yoga (n=20) and control (n=20) by block randomization method. Research findings; Data Form will obtained by using "Introductory Characteristics Form", "Depression, Anxiety, Stress Scale (DASS-21)" and "Psychological Resilience Scale".

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
Completed

Started Aug 2021

Shorter than P25 for not_applicable depression

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

August 8, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 13, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2021

Completed
Last Updated

July 6, 2022

Status Verified

July 1, 2022

Enrollment Period

2 months

First QC Date

August 7, 2021

Last Update Submit

July 5, 2022

Conditions

Keywords

Psychological ResilienceDepressionStressAnxietyNursing

Outcome Measures

Primary Outcomes (2)

  • Depression, Anxiety, Stress Scale (DASS-21)

    It is an assessment tool developed to evaluate the depression, anxiety and stress levels of individuals.

    0-3 point each item, min 0-max 21 total point each subscale

  • Psychological Resilience Scale

    The scale is a scale developed to determine the psychological resilience of individuals, which enables them to return to their former state after negative events.

    min 0-max 40 point

Study Arms (3)

Experimental: Yoga

EXPERIMENTAL
Behavioral: Yoga

Experimental: Laughter Yoga

EXPERIMENTAL
Behavioral: Laughter Yoga

Control

NO INTERVENTION

Interventions

YogaBEHAVIORAL

Yoga will be applied to mothers in the yoga group

Experimental: Yoga
Laughter YogaBEHAVIORAL

Laughter Yoga will be applied to mothers in the yoga group

Experimental: Laughter Yoga

Eligibility Criteria

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

You may qualify if:

  • Mothers who are older than 18 years of age,
  • whose gestational week is less than 32 weeks,
  • whose baby has been treated in the neonatal intensive care unit for at least one week,
  • who have internet access

You may not qualify if:

  • Mothers with a genetic disease or congenital anomaly in their baby

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hasan Kalyoncu University

Gaziantep, Turkey (Türkiye)

Location

MeSH Terms

Conditions

DepressionAnxiety Disorders

Interventions

YogaLaughter Therapy

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 7, 2021

First Posted

August 13, 2021

Study Start

August 8, 2021

Primary Completion

October 1, 2021

Study Completion

October 30, 2021

Last Updated

July 6, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations