- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06217653
Baby Yoga Sleep Maternal Attachment Breastfeeding (Baby Yoga)
The Effect of Baby Yoga on Sleep, Maternal Attachment and Breastfeeding Self-Efficacy: Randomized Trials
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Istanbul
-
Fatih, Istanbul, Turkey
- Istanbul University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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 Plan
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: İntervention
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. 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. It was monitored 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. |
Yoga Video Content Plan
|
No Intervention: Control
Data Collection Form, Postnatal Breastfeeding Self-Efficacy Scale-Short Form, Mother-Infant Attachment Scale, and Sleep Diary were administered to mothers.It was monitored 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maternal Attecment
Time Frame: 16 weeks
|
Attachment level was measured with the Mother-Infant Attachment
|
16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Baby Sleep
Time Frame: 16 weeks
|
Sleep characteristics of infants were measured by means of a sleep diary
|
16 weeks
|
Breastfeeding Self-Efficacy
Time Frame: 16 Weeks
|
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 α value of the scale was found to be 0.82 by Gökçeoğlu and Küçükoğlu (2017).
In this study, the cronbach α value of the scale was found to be 0.85.
|
16 Weeks
|
Collaborators and Investigators
Sponsor
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
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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