Preterm BirthNCT05147480
Online Mother-Baby Yoga With Preterm Infants and Their Mothers
A study testing internet-based mother-baby yoga in people with Preterm Birth and Anxiety, run by Halic University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to examine the effects of internet-based mother-baby yoga on preterm infants and their mothers. Read more about this study
- Who is it for?
- Ages 6 weeks and olderHealthy volunteers can take part
- Conditions the study is for
- Preterm Birth, Anxiety, Development, Infant
- What is being tested?
- internet-based mother-baby yoga
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Jan 2021to 27 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 weeks and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Preterm Birth, Anxiety, Development, Infant
- Being tested
- internet-based mother-baby yoga
- Keywords
- premature infants, yoga, motor performance, COVID-19
- Medical subject headings
- Premature Birth, Anxiety Disorders, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
internet-based mother-baby yogaOther
Mother-baby yoga group classes given by physiotherapists via Zoom Video Communications
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor performance of infants
Alberta Infant Motor Scale (AIMS)
Measured: 15 minutes
Secondary outcomes (4)
Anxiety levels of mothers
State-Trate Anxiety Inventory (STAI)
Measured: 15 minutes
Postpartum bonding of mothers
Postpartum Bonding Questionnaire (PPBQ)
Measured: 15 minutes
Nordic Musculoskeletal Questionnaire (NMQ)
Musculoskeletal problems of mothers
Measured: 10 minutes
Health-related quality of life of mothers
World health organization quality of life questionnaire (WHOQOL-BREF-TR)
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2021
- Study start7 Jan 2021
- Primary completion27 Sep 2021
- Study completion27 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Intervention group (yoga) and control group (standardized protocol)
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Halic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- dilara bozgan, Study director, Istanbul Universitymine çalışkan, Prof.Dr., Principal investigator, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05147480
- Sponsor's protocol ID
- Online Mother-Baby Yoga
- Status last verified
- Aug 2022
- First submitted
- 15 Nov 2021
- Last updated
- 2 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40325668
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Online Mother-Baby Yoga on Preterm Infants and Their Mothers
- ClinicalTrials.gov ID
- NCT05147480
- Acronym / sponsor ID
- Online Mother-Baby Yoga
- Conditions
- Preterm Birth, Anxiety, Development, Infant
- Keywords
- premature infants, yoga, motor performance, COVID-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Halic UniversityUniversity, hospital or other
- Study start
- 7 Jan 2021 (actual)
- Primary completion
- 27 Sep 2021 (actual)
- Study completion
- 27 Sep 2021 (actual)
- First posted
- 7 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the effects of internet-based mother-baby yoga on preterm infants and their mothers.
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
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intervention group (yoga) and control group (standardized protocol)
| Arm | Type | Receives |
|---|---|---|
| yoga group | Active comparator | Other: internet-based mother-baby yogainfants 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 |
| 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 |
Who may qualify
- Ages
- 6 weeks and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| internet-based mother-baby yogaMother-baby yoga group classes given by physiotherapists via Zoom Video Communications | Other | yoga group |
Primary outcome
Motor performance of infants
Time frame: 15 minutes
Alberta Infant Motor Scale (AIMS)
4 secondary outcomes
Anxiety levels of mothers
Time frame: 15 minutes
Postpartum bonding of mothers
Time frame: 15 minutes
Nordic Musculoskeletal Questionnaire (NMQ)
Time frame: 10 minutes
Health-related quality of life of mothers
Time frame: 15 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2022.
- Derived from this study: PubMed 40325668Bozgan-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
dilara bozgan study director
Istanbul University
mine çalışkan, Prof.Dr. principal investigator
Istanbul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing internet-based mother-baby yoga in people with Preterm Birth and Anxiety, run by Halic University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor performance of infants (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05147480, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2022.