NCT06217653

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 20, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 31, 2023

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 22, 2024

Completed
Last Updated

January 22, 2024

Status Verified

January 1, 2024

Enrollment Period

2 months

First QC Date

March 31, 2023

Last Update Submit

January 12, 2024

Conditions

Keywords

SleepMaternalBabyYoga

Outcome Measures

Primary Outcomes (1)

  • Maternal Attecment

    Attachment level was measured with the Mother-Infant Attachment

    16 weeks

Secondary Outcomes (2)

  • Baby Sleep

    16 weeks

  • Breastfeeding Self-Efficacy

    16 Weeks

Study Arms (2)

İntervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

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.

İntervention

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsMother
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Babies born at term (37-40 weeks of gestation)
  • In the first postpartum week,
  • Healthy and singleton newborns were included.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University

Fatih, Istanbul, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
In the study, the researcher and statistician who collected the data were blinded due to the nature of the study. In the data, groups were coded as groups A and B, and only the non-blind researcher who collected the data knew which group was the intervention or control.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The study is of the randomized controlled type.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

March 31, 2023

First Posted

January 22, 2024

Study Start

January 20, 2023

Primary Completion

March 30, 2023

Study Completion

November 30, 2023

Last Updated

January 22, 2024

Record last verified: 2024-01

Locations