- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06359184
Yoga, Mother's Stress and Baby
April 5, 2024 updated by: Ayşe Nur Ozan, Hacettepe University
Examining the Effect of Yoga on Maternal Stress and Sleep Quality of Mother and Baby, Mother's Feeding Attitude and Baby's Feeding Behavior: Randomized Controlled Study.
The aim of this study is to examine the effects of yoga on the stress of mothers with babies with sleep and feeding problems, the mother-infant relationship, and the sleep and nutrition of the mother and the baby.
55 mothers with babies with sleep and feeding problems were included in the study.
Mothers were randomly divided into two groups: yoga (n=29) and control group (n=26).
Yoga training was applied to 29 mothers in the study group via video conferencing, 2 days a week, 1 hour a day for 8 weeks, while the mothers in the control group were given second evaluations 8 weeks after the first evaluation, without any intervention.
Mothers were evaluated with the Perceived Stress Scale (PSS) for stress levels, with Parent-Child Containing Function Scale for the mother-infant relationship, with the Infancy and Early Childhood Feeding Process Mother'sAttitudes Scale for their attitudes towards the feeding process of their babies, and with Attitude Scale for Healthy Nutrition (ASHN) for their own nutrition attitudes, with Pittsburg Sleep Quality (PSQI) for sleep quality and babies with Infancy Period Adaptive Eating Behavior Scale for feeding problems, with Brief Infant/Child Sleep Questionnaire (BISQ) for sleep problems.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
55
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Sarıyer
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Istanbul, Sarıyer, Turkey, 34460
- Ayşe Nur Ozan
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
Parents living together The child must have at least one of the 3 problems listed below on the Infant/Child Sleep Problem Brief Diagnostic Form.
- Waking up more than three times a night
- Waking up at night and being sleepless for more than 1 hour
- Total sleep time is less than 9 hours Having a score above 25 on the Infancy Adaptive Eating Behavior Scale
Exclusion Criteria:
The child has any developmental, neurological, orthopedic and/or psychiatric diagnosis Presence of a condition that prevents the mother from exercising (neurological, cardiovascular, orthopedic, etc.)
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: yoga
Yoga will be practiced 1 hour a day, 2 days a week for 8 weeks, for a total of 16 hours.
|
1 hour yoga practice 2 days a week for 8 weeks
|
|
Placebo Comparator: control
No intervention is applied for 8 weeks.
|
no intervention for 8 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceived Stress Scale (PSS)
Time Frame: At the beginning and end of 8 weeks
|
Evaluated for mother's stress level.
It evaluates the participants on a 5-point Likert-type scale ranging from "Never (0)" to "Very often (4).
|
At the beginning and end of 8 weeks
|
|
Infancy and Early Childhood Feeding Process Mother's Attitudes Scale
Time Frame: At the beginning and end of 8 weeks
|
Evaluated Mother's attitudes towards the feeding process of their babies
|
At the beginning and end of 8 weeks
|
|
Pittsburg Sleep Quality (PSQI)
Time Frame: At the beginning and end of 8 weeks
|
Evaluated mother's sleep quality
|
At the beginning and end of 8 weeks
|
|
Period Adaptive Eating Behavior Scale
Time Frame: At the beginning and end of 8 weeks
|
Evaluated babies feeding problems
|
At the beginning and end of 8 weeks
|
|
Brief Infant/Child Sleep Questionnaire (BISQ)
Time Frame: At the beginning and end of 8 weeks
|
Evaluated babies sleep problems.
If at least one of the following three conditions occurs, it is determined that the baby/child has a sleep problem; 1) The baby/child wakes up more than three times a night, 2) The baby/child wakes up at night and remains sleepless for more than an hour, or, 3) The baby/child's total sleep time is less than 9 hours.
|
At the beginning and end of 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2023
Primary Completion (Actual)
February 1, 2024
Study Completion (Actual)
February 15, 2024
Study Registration Dates
First Submitted
April 2, 2024
First Submitted That Met QC Criteria
April 5, 2024
First Posted (Actual)
April 11, 2024
Study Record Updates
Last Update Posted (Actual)
April 11, 2024
Last Update Submitted That Met QC Criteria
April 5, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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