- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05147480
Online Mother-Baby Yoga With Preterm Infants and Their Mothers
August 31, 2022 updated by: Halic University
The Effects of Online Mother-Baby Yoga on Preterm Infants and Their Mothers
The purpose of this study is to examine the effects of internet-based mother-baby yoga on preterm infants and their mothers.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
29
Phase
- 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
-
-
-
İstanbul, Turkey, 34394
- Dilara Bozgan
-
-
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
Ages Eligible for Study
1 month and older (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
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: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / 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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Motor performance of infants
Time Frame: 15 minutes
|
Alberta Infant Motor Scale (AIMS)
|
15 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anxiety levels of mothers
Time Frame: 15 minutes
|
State-Trate Anxiety Inventory (STAI)
|
15 minutes
|
|
Postpartum bonding of mothers
Time Frame: 15 minutes
|
Postpartum Bonding Questionnaire (PPBQ)
|
15 minutes
|
|
Nordic Musculoskeletal Questionnaire (NMQ)
Time Frame: 10 minutes
|
Musculoskeletal problems of mothers
|
10 minutes
|
|
Health-related quality of life of mothers
Time Frame: 15 minutes
|
World health organization quality of life questionnaire (WHOQOL-BREF-TR)
|
15 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: dilara bozgan, Istanbul University
- Principal Investigator: mine çalışkan, Prof.Dr., Istanbul 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)
January 7, 2021
Primary Completion (ACTUAL)
September 27, 2021
Study Completion (ACTUAL)
September 27, 2021
Study Registration Dates
First Submitted
November 15, 2021
First Submitted That Met QC Criteria
November 24, 2021
First Posted (ACTUAL)
December 7, 2021
Study Record Updates
Last Update Posted (ACTUAL)
September 2, 2022
Last Update Submitted That Met QC Criteria
August 31, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Online Mother-Baby Yoga
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.