Online Mother-Baby Yoga With Preterm Infants and Their Mothers

Sponsor

Halic University (Other)

Overall Status

Completed

CT.gov ID

NCT05147480

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

4.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Preterm Birth Anxiety Development, Infant	Other: internet-based mother-baby yoga	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

29 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Intervention group (yoga) and control group (standardized protocol)Intervention group (yoga) and control group (standardized protocol)

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

The Effects of Online Mother-Baby Yoga on Preterm Infants and Their Mothers

Actual Study Start Date :

Jun 1, 2021

Actual Primary Completion Date :

Dec 1, 2021

Actual Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: yoga group 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	Other: internet-based mother-baby yoga Mother-baby yoga group classes given by physiotherapists via Zoom Video Communications
No Intervention: control group 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

Arm

Intervention/Treatment

Active Comparator: yoga group

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

Other: internet-based mother-baby yoga

Mother-baby yoga group classes given by physiotherapists via Zoom Video Communications

No Intervention: control group

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

Outcome Measures

Primary Outcome Measures

Motor performance of infants [15 minutes]
Alberta Infant Motor Scale (AIMS)

Secondary Outcome Measures

Anxiety levels of mothers [15 minutes]
State-Trate Anxiety Inventory (STAI)
Postpartum bonding of mothers [15 minutes]
Postpartum Bonding Questionnaire (PPBQ)
Nordic Musculoskeletal Questionnaire (NMQ) [10 minutes]
Musculoskeletal problems of mothers
Health-related quality of life of mothers [15 minutes]
World health organization quality of life questionnaire (WHOQOL-BREF-TR)

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Weeks and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dilara Bozgan	İstanbul		Turkey	34394

Sponsors and Collaborators

Halic University

Investigators

Study Director: dilara bozgan, Istanbul University
Principal Investigator: mine çalışkan, Prof.Dr., Istanbul University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Halic University

ClinicalTrials.gov Identifier:

NCT05147480

Other Study ID Numbers:

Online Mother-Baby Yoga

First Posted:

Dec 7, 2021

Last Update Posted:

Jan 18, 2022

Last Verified:

Jan 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Halic University

Additional relevant MeSH terms:

Premature Birth

Study Results

No Results Posted as of Jan 18, 2022