NCT05147480

Brief Summary

The purpose of this study is to examine the effects of internet-based mother-baby yoga on preterm infants and their mothers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2021

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 7, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 27, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 27, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

December 7, 2021

Completed
Last Updated

September 2, 2022

Status Verified

August 1, 2022

Enrollment Period

9 months

First QC Date

November 15, 2021

Last Update Submit

August 31, 2022

Conditions

Keywords

premature infantsyogamotor performanceCOVID-19

Outcome Measures

Primary Outcomes (1)

  • Motor performance of infants

    Alberta Infant Motor Scale (AIMS)

    15 minutes

Secondary Outcomes (4)

  • Anxiety levels of mothers

    15 minutes

  • Postpartum bonding of mothers

    15 minutes

  • Nordic Musculoskeletal Questionnaire (NMQ)

    10 minutes

  • Health-related quality of life of mothers

    15 minutes

Study Arms (2)

yoga group

ACTIVE COMPARATOR

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

control group

NO INTERVENTION

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

Interventions

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

yoga group

Eligibility Criteria

Age6 Weeks+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dilara Bozgan

Istanbul, 34394, Turkey (Türkiye)

Location

Related Publications (1)

  • Bozgan-Bas D, Ince EZ, Kavram G, Caliskan MM. Tele-MiYo: A tele-yoga program for mother-preterm infant dyads. J Bodyw Mov Ther. 2025 Jun;42:192-197. doi: 10.1016/j.jbmt.2024.12.018. Epub 2024 Dec 12.

MeSH Terms

Conditions

Premature BirthAnxiety DisordersCOVID-19

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMental DisordersPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • dilara bozgan

    Istanbul University

    STUDY DIRECTOR
  • mine çalışkan, Prof.Dr.

    Istanbul University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Intervention group (yoga) and control group (standardized protocol)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2021

First Posted

December 7, 2021

Study Start

January 7, 2021

Primary Completion

September 27, 2021

Study Completion

September 27, 2021

Last Updated

September 2, 2022

Record last verified: 2022-08

Locations