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Online Mother-Baby Yoga With Preterm Infants and Their Mothers

Primary Purpose

Preterm Birth, Anxiety, Development, Infant

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
internet-based mother-baby yoga
Sponsored by
Halic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Preterm Birth focused on measuring premature infants, yoga, motor performance, COVID-19

Eligibility Criteria

6 Weeks - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • The infants whose gestational age between 32 0/7-36 6/7 week and corrected age's older than 6 weeks and their mothers
  • Caregivers who have at least one smartphone or/and laptop or/and Ipad
  • Mothers and their babies who accept to register to the study

Exclusion Criteria:

  • The infants who have a severe pathological sign in cranial screening
  • The infants who had IVH
  • The infants who have congenital abnormalities
  • The infants who have a metabolic or genetic diagnosis
  • The infants who have hearing or visual impairment
  • The mothers who had chronic depression history and/or mental retardation
  • The mothers who have a neurological or orthopedic diagnosis to the contraindication of exercise
  • The mothers who are pregnant

Sites / Locations

  • Dilara Bozgan

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

yoga group

control group

Arm Description

infants whose gestational ages are between 32-37 weeks and completed the corrected age of the 6th week, and their mothers intervention: 6-week, once a week internet-based mother and baby yoga

infants whose gestational ages are between 32-37 weeks and completed the corrected age of the 6th week, and their mothers the standardized follow-up without intervention

Outcomes

Primary Outcome Measures

Motor performance of infants
Alberta Infant Motor Scale (AIMS)

Secondary Outcome Measures

Anxiety levels of mothers
State-Trate Anxiety Inventory (STAI)
Postpartum bonding of mothers
Postpartum Bonding Questionnaire (PPBQ)
Nordic Musculoskeletal Questionnaire (NMQ)
Musculoskeletal problems of mothers
Health-related quality of life of mothers
World health organization quality of life questionnaire (WHOQOL-BREF-TR)

Full Information

First Posted
November 15, 2021
Last Updated
August 31, 2022
Sponsor
Halic University
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1. Study Identification

Unique Protocol Identification Number
NCT05147480
Brief Title
Online Mother-Baby Yoga With Preterm Infants and Their Mothers
Official Title
The Effects of Online Mother-Baby Yoga on Preterm Infants and Their Mothers
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
January 7, 2021 (Actual)
Primary Completion Date
September 27, 2021 (Actual)
Study Completion Date
September 27, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Halic University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The purpose of this study is to examine the effects of internet-based mother-baby yoga on preterm infants and their mothers.
Detailed Description
Mother-infant pairs were enrolled in the study. Interventions applied as group sessions (maximum of 5 mother-infant pairs) for 6 weeks, once a week. Yoga sessions Before-after evaluations were done for both mother and infant outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Birth, Anxiety, Development, Infant
Keywords
premature infants, yoga, motor performance, COVID-19

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Intervention group (yoga) and control group (standardized protocol)
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
yoga group
Arm Type
Active Comparator
Arm Description
infants whose gestational ages are between 32-37 weeks and completed the corrected age of the 6th week, and their mothers intervention: 6-week, once a week internet-based mother and baby yoga
Arm Title
control group
Arm Type
No Intervention
Arm Description
infants whose gestational ages are between 32-37 weeks and completed the corrected age of the 6th week, and their mothers the standardized follow-up without intervention
Intervention Type
Other
Intervention Name(s)
internet-based mother-baby yoga
Intervention Description
Mother-baby yoga group classes given by physiotherapists via Zoom Video Communications
Primary Outcome Measure Information:
Title
Motor performance of infants
Description
Alberta Infant Motor Scale (AIMS)
Time Frame
15 minutes
Secondary Outcome Measure Information:
Title
Anxiety levels of mothers
Description
State-Trate Anxiety Inventory (STAI)
Time Frame
15 minutes
Title
Postpartum bonding of mothers
Description
Postpartum Bonding Questionnaire (PPBQ)
Time Frame
15 minutes
Title
Nordic Musculoskeletal Questionnaire (NMQ)
Description
Musculoskeletal problems of mothers
Time Frame
10 minutes
Title
Health-related quality of life of mothers
Description
World health organization quality of life questionnaire (WHOQOL-BREF-TR)
Time Frame
15 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: The infants whose gestational age between 32 0/7-36 6/7 week and corrected age's older than 6 weeks and their mothers Caregivers who have at least one smartphone or/and laptop or/and Ipad Mothers and their babies who accept to register to the study Exclusion Criteria: The infants who have a severe pathological sign in cranial screening The infants who had IVH The infants who have congenital abnormalities The infants who have a metabolic or genetic diagnosis The infants who have hearing or visual impairment The mothers who had chronic depression history and/or mental retardation The mothers who have a neurological or orthopedic diagnosis to the contraindication of exercise The mothers who are pregnant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
dilara bozgan
Organizational Affiliation
Istanbul University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
mine çalışkan, Prof.Dr.
Organizational Affiliation
Istanbul University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dilara Bozgan
City
İstanbul
ZIP/Postal Code
34394
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

Online Mother-Baby Yoga With Preterm Infants and Their Mothers

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