NCT06359184

Brief Summary

The aim of this study is to examine the effects of yoga on the stress of mothers with babies with sleep and feeding problems, the mother-infant relationship, and the sleep and nutrition of the mother and the baby. 55 mothers with babies with sleep and feeding problems were included in the study. Mothers were randomly divided into two groups: yoga (n=29) and control group (n=26). Yoga training was applied to 29 mothers in the study group via video conferencing, 2 days a week, 1 hour a day for 8 weeks, while the mothers in the control group were given second evaluations 8 weeks after the first evaluation, without any intervention. Mothers were evaluated with the Perceived Stress Scale (PSS) for stress levels, with Parent-Child Containing Function Scale for the mother-infant relationship, with the Infancy and Early Childhood Feeding Process Mother'sAttitudes Scale for their attitudes towards the feeding process of their babies, and with Attitude Scale for Healthy Nutrition (ASHN) for their own nutrition attitudes, with Pittsburg Sleep Quality (PSQI) for sleep quality and babies with Infancy Period Adaptive Eating Behavior Scale for feeding problems, with Brief Infant/Child Sleep Questionnaire (BISQ) for sleep problems.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2023

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 2, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 11, 2024

Completed
Last Updated

April 11, 2024

Status Verified

April 1, 2024

Enrollment Period

3 months

First QC Date

April 2, 2024

Last Update Submit

April 5, 2024

Conditions

Keywords

yogamothersbabystresssleepnutrition

Outcome Measures

Primary Outcomes (5)

  • Perceived Stress Scale (PSS)

    Evaluated for mother's stress level. It evaluates the participants on a 5-point Likert-type scale ranging from "Never (0)" to "Very often (4).

    At the beginning and end of 8 weeks

  • Infancy and Early Childhood Feeding Process Mother's Attitudes Scale

    Evaluated Mother's attitudes towards the feeding process of their babies

    At the beginning and end of 8 weeks

  • Pittsburg Sleep Quality (PSQI)

    Evaluated mother's sleep quality

    At the beginning and end of 8 weeks

  • Period Adaptive Eating Behavior Scale

    Evaluated babies feeding problems

    At the beginning and end of 8 weeks

  • Brief Infant/Child Sleep Questionnaire (BISQ)

    Evaluated babies sleep problems. If at least one of the following three conditions occurs, it is determined that the baby/child has a sleep problem; 1) The baby/child wakes up more than three times a night, 2) The baby/child wakes up at night and remains sleepless for more than an hour, or, 3) The baby/child's total sleep time is less than 9 hours.

    At the beginning and end of 8 weeks

Study Arms (2)

yoga

EXPERIMENTAL

Yoga will be practiced 1 hour a day, 2 days a week for 8 weeks, for a total of 16 hours.

Other: yoga

control

PLACEBO COMPARATOR

No intervention is applied for 8 weeks.

Other: control

Interventions

yogaOTHER

1 hour yoga practice 2 days a week for 8 weeks

yoga
controlOTHER

no intervention for 8 weeks

control

Eligibility Criteria

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

You may qualify if:

  • Parents living together The child must have at least one of the 3 problems listed below on the Infant/Child Sleep Problem Brief Diagnostic Form.
  • Waking up more than three times a night
  • Waking up at night and being sleepless for more than 1 hour
  • Total sleep time is less than 9 hours Having a score above 25 on the Infancy Adaptive Eating Behavior Scale

You may not qualify if:

  • The child has any developmental, neurological, orthopedic and/or psychiatric diagnosis Presence of a condition that prevents the mother from exercising (neurological, cardiovascular, orthopedic, etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ayşe Nur Ozan

Istanbul, Sarıyer, 34460, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Yoga

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
occupational therapist

Study Record Dates

First Submitted

April 2, 2024

First Posted

April 11, 2024

Study Start

November 1, 2023

Primary Completion

February 1, 2024

Study Completion

February 15, 2024

Last Updated

April 11, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations