NCT06202937

Brief Summary

The research will be carried out in a randomized controlled manner to determine the positive benefits of yoga for mothers and babies who have given birth preterm and have been discharged, and to determine its effect on Fragile Baby Perception Syndrome, maternal attachment, depression-anxiety-stress levels.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

August 2, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 2, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 12, 2024

Completed
Last Updated

December 10, 2025

Status Verified

December 1, 2025

Enrollment Period

4 months

First QC Date

January 2, 2024

Last Update Submit

December 3, 2025

Conditions

Keywords

Mother-Baby YogaFragile Baby Perception SyndromeMaternal AttachmentDepression-Anxiety-Stress

Outcome Measures

Primary Outcomes (3)

  • Fragile Infant Perception Scale

    it is an assessment tool developed to evaulate Fragile Infant Perception The total score of the scale is 50. A score of 27 or above from the scale indicates that the perception of fragility is high.

    8 weeks

  • Maternal Attachment Scale

    The scale contains direct statements rated between 1-4 (never, sometimes, often, always). Scores between 26 and 104 are obtained from the scale. A higher score means higher maternal attachment.

    8 weeks

  • Depression, Anxiety, Stress Scale (DASS-21

    0-3 point each item min 0 max 21 total point each subscale

    8 weeks

Study Arms (2)

mother baby yoga

EXPERIMENTAL

Mother-baby yoga will be held with the babies discharged from the neonatal intensive care unit and their mothers

Behavioral: Mother Baby Yoga

control

EXPERIMENTAL

the control group received the usual care

Other: No intervention:control

Interventions

Fragile Baby Perception Syndrome, Maternal Attachment, Depression-Anxiety-Stress Level

mother baby yoga

the control group received the usual care

control

Eligibility Criteria

Age2 Months - 4 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Baby;
  • Born earlier than 37 weeks of gestation,
  • Those who were treated in the neonatal intensive care unit and discharged at least 8 and at most 16 weeks ago,
  • Does not have any chronic disease,
  • No congenital defects,
  • Babies who have been evaluated for Developmental Hip Dysplasia and have received approval from their physician to practice yoga.
  • Mother's;
  • Speaks Turkish,
  • Those who are over 18 years old,
  • Having internet access at home
  • No physical illness that prevents yoga
  • Those who want to participate in the study voluntarily,
  • Mothers who have been approved by their physician to do yoga

You may not qualify if:

  • Their baby has a genetic disease or congenital disorder,
  • Mothers and babies who are declared unsuitable for yoga by the physician
  • Mothers who have not completed 10 courses or who wish to withdraw at any stage of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Emine Sarıkamış Kale

Batman, Merkez, 72000, Turkey (Türkiye)

Location

Hasan Kalyoncu University

Gaziantep, Şahinbey, Turkey (Türkiye)

Location

Related Publications (1)

  • Koc Ozkan T, Cigdem Z, Sarikamis Kale E, Kale Y. The effect of mother-baby yoga on mother's depression-anxiety-stress levels, perception of fragile baby, and maternal bonding: A randomized controlled trial. J Pediatr Nurs. 2025 Nov-Dec;85:171-180. doi: 10.1016/j.pedn.2025.07.029. Epub 2025 Jul 31.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Phd student

Study Record Dates

First Submitted

January 2, 2024

First Posted

January 12, 2024

Study Start

August 2, 2023

Primary Completion

November 30, 2023

Study Completion

December 2, 2023

Last Updated

December 10, 2025

Record last verified: 2025-12

Locations