- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05005546
The Effect of Yoga and Laughter Yoga on Increasing the Psychological Resilience of Mothers
The Effect of Yoga and Laughter Yoga on Increasing the Psychological Resilience of Mothers With Their Babies in the Neonatal Intensive Care Unit
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".
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Gaziantep, Turkey
- Hasan Kalyoncu University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Mothers with a genetic disease or congenital anomaly in their baby
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
|
|
|
Experimental: Experimental: Yoga
|
Yoga will be applied to mothers in the yoga group
|
|
Experimental: Experimental: Laughter Yoga
|
Laughter Yoga will be applied to mothers in the yoga group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Depression, Anxiety, Stress Scale (DASS-21)
Time Frame: 0-3 point each item, min 0-max 21 total point each subscale
|
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
Time Frame: min 0-max 40 point
|
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
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021/085
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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