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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06217653
Other study ID # Yoga Çalisma
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 20, 2023
Est. completion date November 30, 2023

Study information

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

Clinical Trial Summary

The randomized controlled type study was conducted with 150 mothers and mothers who gave birth in the Haseki Training and Research Hospital Postpartum Service between February and February. The mothers included in the study were randomized 1:1 into 2 groups. The mothers of the babies in the intervention group were sent a "Baby Yoga" video shot by the researchers and asked to practice them at least 3 times a week for 4 weeks. Data are obtained with Data collection form, Mother-Infant Attachment Scale, Breastfeeding Self-Efficacy Short Form and Baby Sleep Diary.


Description:

This study was conducted in a randomized controlled type to examine the effect of infant yoga practiced by mothers on infants' sleep duration, maternal attachment and breastfeeding. The enrollment, assignment, follow-up and analysis steps of the trial were demonstrated using CONSORT 2018 (Updated Guidelines for Reporting Randomized Parallel Group Studies). While the population of the study consisted of mothers and babies who gave birth in the Haseki Training and Research Hospital Obstetrics Clinic, the minimum sample number was calculated using G Power. Accordingly, it was found that the number of samples to be taken was 68 for each group, a total of 136 mothers and their babies. Considering that there would be losses, the sample was planned to be 150 mothers and their babies, 75 for each group. Sample Selection Criteria - Babies born at term (37-40 weeks of gestation) - In the first postpartum week, - Healthy and singleton newborns were included. Sample Exclusion Criteria - Babies staying in the postnatal intensive care unit, - The mother has a physical disability, - The mother has a psychiatric illness, - Being pregnant using assisted reproductive techniques, - Not included if the mother or baby has a disability related to breastfeeding Data Collection Tools The data of the study were obtained by using the Data Collection Form, Postnatal Breastfeeding Self-Efficacy Scale-Short Form, Mother-Infant Attachment Scale, and Sleep Diary. Data Collection Stages Stage 1: 150 mothers and their babies who met the sample selection criteria were included in the study in the first postpartum week. Mothers were randomized into two groups as intervention and control. Data Collection Form, Postnatal Breastfeeding Self-Efficacy Scale-Short Form, Mother-Infant Attachment Scale, and Sleep Diary were administered to all mothers. Stage 2: Intervention Group: A mother-baby yoga video prepared by the researchers was sent to the mothers in the intervention group. Before the mothers yoga practice, a 10-minute training was given about mother-baby yoga. Mothers were asked to do yoga at least 3 times a week for 4 weeks. Counseling and follow-up of the process were carried out by a researcher by calling the mothers once a week. Yoga Video Content Plan - Mood Regulation: Abdominal/Belly Breathing - Warm Touch from the Heart - Chair Posture - Bucket Wrapping - Bukka Bukka (Heart) - Vortex Generation - Fertile Falls - One Hand Two Hands - Tiny Stretches - Here and Now Awareness - Dolphin Pose Mothers were asked to choose the most suitable time of the day for the baby and herself, to have the baby fed at least 45 minutes before yoga, and to practice in a calm and dim environment, listening to music or white noise of her choice. Approximately one yoga session is 20 minutes. Control group: Left for routine care. Stage 3: All babies and their mothers were followed up once a week for 4 weeks, a total of 4 times. Postnatal Breastfeeding Self-Efficacy Scale-Short Form, Mother-Infant Attachment Scale, and Sleep Diary were administered to mothers at each follow-up.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date November 30, 2023
Est. primary completion date March 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria: - Babies born at term (37-40 weeks of gestation) - In the first postpartum week, - Healthy and singleton newborns were included. Exclusion Criteria: - Babies staying in the postnatal intensive care unit, - The mother has a physical disability, - The mother has a psychiatric illness, - Being pregnant using assisted reproductive techniques, - Not included if the mother or baby has a disability related to breastfeeding

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
mother baby yoga
Yoga Video Content Plan Mood Regulation: Abdominal/Belly Breathing Warm Touch from the Heart Chair Posture Bucket Wrapping Bukka Bukka (Heart) Vortex Generation Fertile Falls One Hand Two Hands Tiny Stretches Here and Now Awareness Dolphin Pose Mothers were asked to choose the most suitable time of the day for the baby and herself, to have the baby fed at least 45 minutes before yoga, and to practice in a calm and dim environment, listening to music or white noise of her choice. Approximately one yoga session is 20 minutes.

Locations

Country Name City State
Turkey Istanbul University Fatih Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Halic University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maternal Attecment Attachment level was measured with the Mother-Infant Attachment 16 weeks
Secondary Baby Sleep Sleep characteristics of infants were measured by means of a sleep diary 16 weeks
Secondary Breastfeeding Self-Efficacy Breastfeeding Self-Efficacy Short Form The scale was developed by McCarter-Spaulding (2001) to measure how adequately the mother perceives her milk. The Insufficient Milk Perception scale consists of a total of 6 questions and a single subdivision. The first question on the scale is whether the mother finds her milk sufficient. The first question is answered as yes or no. The other 5 questions are scored between 0-10. The given score indicates that as it approaches zero, the mother perceives her milk as inadequate, and as she approaches 10, she perceives enough. A minimum of zero points and a maximum of 50 points can be obtained from the scale. The high score indicates that milk is sufficiently perceived. The cronbach a value of the scale was found to be 0.82 by Gökçeoglu and Küçükoglu (2017). In this study, the cronbach a value of the scale was found to be 0.85. 16 Weeks
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