Baby Yoga Sleep Maternal Attachment Breastfeeding (Baby Yoga)

January 12, 2024 updated by: Fatma Şule Bilgiç, Halic University

The Effect of Baby Yoga on Sleep, Maternal Attachment and Breastfeeding Self-Efficacy: Randomized Trials

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Turkey
    • Istanbul
      • Fatih, Istanbul, Turkey
        • Istanbul University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

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

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Halic University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 20, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 31, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 22, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 22, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Yoga Çalışma

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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