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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06359184
Other study ID # GO21/1011
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2023
Est. completion date February 15, 2024

Study information

Verified date April 2024
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 55
Est. completion date February 15, 2024
Est. primary completion date February 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility 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. 1. Waking up more than three times a night 2. Waking up at night and being sleepless for more than 1 hour 3. 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 Design


Related Conditions & MeSH terms


Intervention

Other:
yoga
1 hour yoga practice 2 days a week for 8 weeks
control
no intervention for 8 weeks

Locations

Country Name City State
Turkey Ayse Nur Ozan Istanbul Sariyer

Sponsors (1)

Lead Sponsor Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Perceived Stress Scale (PSS) 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
Primary Infancy and Early Childhood Feeding Process Mother's Attitudes Scale Evaluated Mother's attitudes towards the feeding process of their babies At the beginning and end of 8 weeks
Primary Pittsburg Sleep Quality (PSQI) Evaluated mother's sleep quality At the beginning and end of 8 weeks
Primary Period Adaptive Eating Behavior Scale Evaluated babies feeding problems At the beginning and end of 8 weeks
Primary Brief Infant/Child Sleep Questionnaire (BISQ) 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
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