Maternal BehaviorBaby YogaNCT06217653
Baby Yoga Sleep Maternal Attachment Breastfeeding
A study testing mother baby yoga in people with Maternal Behavior and Maternal Care Patterns, run by Halic University at 1 site in Turkey (Türkiye).
Trial summary
The randomized controlled type study was conducted with 150 mothers and mothers who gave birth in the Haseki Training and Research Hospital Postpartum Service between February and February. The mothers included in the study were randomized 1:1 into 2 groups. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Maternal Behavior, Maternal Care Patterns
- What is being tested?
- mother baby yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jan 2023to 30 Nov 2023
- 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 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Babies born at term (37-40 weeks of gestation)
- In the first postpartum week,
- Healthy and singleton newborns were included.
Who cannot join
- Babies staying in the postnatal intensive care unit,
- The mother has a physical disability,
- The mother has a psychiatric illness,
- Being pregnant using assisted reproductive techniques,
- Not included if the mother or baby has a disability related to breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Baby Yoga on Sleep, Maternal Attachment and Breastfeeding Self-Efficacy: Randomized Trials
The randomized controlled type study was conducted with 150 mothers and mothers who gave birth in the Haseki Training and Research Hospital Postpartum Service between February and February. The mothers included in the study were randomized 1:1 into 2 groups. The mothers of the babies in the intervention group were sent a "Baby Yoga" video shot by the researchers and asked to practice them at least 3 times a week for 4 weeks. Data are obtained with Data collection form, Mother-Infant Attachment Scale, Breastfeeding Self-Efficacy Short Form and Baby Sleep Diary.
Read the detailed description
This study was conducted in a randomized controlled type to examine the effect of infant yoga practiced by mothers on infants' sleep duration, maternal attachment and breastfeeding. The enrollment, assignment, follow-up and analysis steps of the trial were demonstrated using CONSORT 2018 (Updated Guidelines for Reporting Randomized Parallel Group Studies).
While the population of the study consisted of mothers and babies who gave birth in the Haseki Training and Research Hospital Obstetrics Clinic, the minimum sample number was calculated using G Power. Accordingly, it was found that the number of samples to be taken was 68 for each group, a total of 136 mothers and their babies. Considering that there would be losses, the sample was planned to be 150 mothers and their babies, 75 for each group.
Sample Selection Criteria
- Babies born at term (37-40 weeks of gestation)
- In the first postpartum week,
- Healthy and singleton newborns were included. Sample Exclusion Criteria
- Babies staying in the postnatal intensive care unit,
- The mother has a physical disability,
- The mother has a psychiatric illness,
- Being pregnant using assisted reproductive techniques,
- Not included if the mother or baby has a disability related to breastfeeding
Data Collection Tools The data of the study were obtained by using the Data Collection Form, Postnatal Breastfeeding Self-Efficacy Scale-Short Form, Mother-Infant Attachment Scale, and Sleep Diary.
Data Collection Stages Stage 1: 150 mothers and their babies who met the sample selection criteria were included in the study in the first postpartum week. Mothers were randomized into two groups as intervention and control. Data Collection Form, Postnatal Breastfeeding Self-Efficacy Scale-Short Form, Mother-Infant Attachment Scale, and Sleep Diary were administered to all mothers.
Stage 2: Intervention Group: A mother-baby yoga video prepared by the researchers was sent to the mothers in the intervention group. Before the mothers yoga practice, a 10-minute training was given about mother-baby yoga. Mothers were asked to do yoga at least 3 times a week for 4 weeks. Counseling and follow-up of the process were carried out by a researcher by calling the mothers once a week.
Yoga Video Content Plan
- Mood Regulation: Abdominal/Belly Breathing
- Warm Touch from the Heart
- Chair Posture
- Bucket Wrapping
- Bukka Bukka (Heart)
- Vortex Generation
- Fertile Falls
- One Hand Two Hands
- Tiny Stretches
- Here and Now Awareness
- Dolphin Pose Mothers were asked to choose the most suitable time of the day for the baby and herself, to have the baby fed at least 45 minutes before yoga, and to practice in a calm and dim environment, listening to music or white noise of her choice. Approximately one yoga session is 20 minutes.
Control group: Left for routine care. Stage 3: All babies and their mothers were followed up once a week for 4 weeks, a total of 4 times. Postnatal Breastfeeding Self-Efficacy Scale-Short Form, Mother-Infant Attachment Scale, and Sleep Diary were administered to mothers at each follow-up.
- Conditions
- Maternal Behavior, Maternal Care Patterns
- Being tested
- mother baby yoga
- Keywords
- Sleep, Maternal, Baby, Yoga
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mother baby yogaBehavioural
Yoga Video Content Plan
- Mood Regulation: Abdominal/Belly Breathing
- Warm Touch from the Heart
- Chair Posture
- Bucket Wrapping
- Bukka Bukka (Heart)
- Vortex Generation
- Fertile Falls
- One Hand Two Hands
- Tiny Stretches
- Here and Now Awareness
- Dolphin Pose Mothers were asked to choose the most suitable time of the day for the baby and herself, to have the baby fed at least 45 minutes before yoga, and to practice in a calm and dim environment, listening to music or white noise of her choice. Approximately one yoga session is 20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| İntervention | Experimental | Intervention Group: A mother-baby yoga video prepared by the researchers was sent to the mothers in the intervention group. Before the mothers yoga practice, a 10-minute training was given about mother-baby yoga. Mothers were asked to do yoga at least 3 times a week for 4 weeks. Counseling and follow-up of the process were carried out by a researcher by calling the mothers once a week.
Mothers were asked to choose the most suitable time of the day for the baby and herself, to have the baby fed at least 45 minutes before yoga, and to practice in a calm and dim environment, listening to music or white noise of her choice. Approximately one yoga session is 20 minutes.
It was monitored once a week for 4 weeks, a total of 4 times. Postnatal Breastfeeding Self-Efficacy Scale-Short Form, Mother-Infant Attachment Scale, and Sleep Diary were administered to mothers at each follow-up. Receives: Behavioral: mother baby yoga |
| Control | No intervention | Data Collection Form, Postnatal Breastfeeding Self-Efficacy Scale-Short Form, Mother-Infant Attachment Scale, and Sleep Diary were administered to mothers.It was monitored once a week for 4 weeks, a total of 4 times. Postnatal Breastfeeding Self-Efficacy Scale-Short Form, Mother-Infant Attachment Scale, and Sleep Diary were administered to mothers at each follow-up. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal Attecment
Attachment level was measured with the Mother-Infant Attachment
Measured: 16 weeks
Secondary outcomes (2)
Baby Sleep
Sleep characteristics of infants were measured by means of a sleep diary
Measured: 16 weeks
Breastfeeding Self-Efficacy
Breastfeeding Self-Efficacy Short Form The scale was developed by McCarter-Spaulding (2001) to measure how adequately the mother perceives her milk. The Insufficient Milk Perception scale consists of a total of 6 questions and a single subdivision. The first question on the scale is whether the mother finds her milk sufficient. The first question is answered as yes or no. The other 5 questions are scored between 0-10. The given score indicates that as it approaches zero, the mother perceives her milk as inadequate, and as she approaches 10, she perceives enough. A minimum of zero points and a maximum of 50 points can be obtained from the scale. The high score indicates that milk is sufficiently perceived. The cronbach α value of the scale was found to be 0.82 by Gökçeoğlu and Küçükoğlu (2017). In this study, the cronbach α value of the scale was found to be 0.85.
Measured: 16 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start20 Jan 2023
- Primary completion30 Mar 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal BehaviorStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is of the randomized controlled type.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Halic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Şule Bilgiç, Halic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06217653
- Sponsor's protocol ID
- Yoga Çalışma
- Acronym
- Baby Yoga
- Status last verified
- Jan 2024
- First submitted
- 31 Mar 2023
- Last updated
- 22 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Baby Yoga on Sleep, Maternal Attachment and Breastfeeding Self-Efficacy: Randomized Trials
- ClinicalTrials.gov ID
- NCT06217653
- Acronym / sponsor ID
- Baby Yoga / Yoga Çalışma
- Conditions
- Maternal Behavior, Maternal Care Patterns
- Keywords
- Sleep, Maternal, Baby, Yoga
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Halic UniversityUniversity, hospital or other
- Study start
- 20 Jan 2023 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 22 Jan 2024 (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 randomized controlled type study was conducted with 150 mothers and mothers who gave birth in the Haseki Training and Research Hospital Postpartum Service between February and February. The mothers included in the study were randomized 1:1 into 2 groups. The mothers of the babies in the intervention group were sent a "Baby Yoga" video shot by the researchers and asked to practice them at least 3 times a week for 4 weeks. Data are obtained with Data collection form, Mother-Infant Attachment Scale, Breastfeeding Self-Efficacy Short Form and Baby Sleep Diary.
Detailed description
This study was conducted in a randomized controlled type to examine the effect of infant yoga practiced by mothers on infants' sleep duration, maternal attachment and breastfeeding. The enrollment, assignment, follow-up and analysis steps of the trial were demonstrated using CONSORT 2018 (Updated Guidelines for Reporting Randomized Parallel Group Studies).
While the population of the study consisted of mothers and babies who gave birth in the Haseki Training and Research Hospital Obstetrics Clinic, the minimum sample number was calculated using G Power. Accordingly, it was found that the number of samples to be taken was 68 for each group, a total of 136 mothers and their babies. Considering that there would be losses, the sample was planned to be 150 mothers and their babies, 75 for each group.
Sample Selection Criteria
- Babies born at term (37-40 weeks of gestation)
- In the first postpartum week,
- Healthy and singleton newborns were included. Sample Exclusion Criteria
- Babies staying in the postnatal intensive care unit,
- The mother has a physical disability,
- The mother has a psychiatric illness,
- Being pregnant using assisted reproductive techniques,
- Not included if the mother or baby has a disability related to breastfeeding
Data Collection Tools The data of the study were obtained by using the Data Collection Form, Postnatal Breastfeeding Self-Efficacy Scale-Short Form, Mother-Infant Attachment Scale, and Sleep Diary.
Data Collection Stages Stage 1: 150 mothers and their babies who met the sample selection criteria were included in the study in the first postpartum week. Mothers were randomized into two groups as intervention and control. Data Collection Form, Postnatal Breastfeeding Self-Efficacy Scale-Short Form, Mother-Infant Attachment Scale, and Sleep Diary were administered to all mothers.
Stage 2: Intervention Group: A mother-baby yoga video prepared by the researchers was sent to the mothers in the intervention group. Before the mothers yoga practice, a 10-minute training was given about mother-baby yoga. Mothers were asked to do yoga at least 3 times a week for 4 weeks. Counseling and follow-up of the process were carried out by a researcher by calling the mothers once a week.
Yoga Video Content Plan
- Mood Regulation: Abdominal/Belly Breathing
- Warm Touch from the Heart
- Chair Posture
- Bucket Wrapping
- Bukka Bukka (Heart)
- Vortex Generation
- Fertile Falls
- One Hand Two Hands
- Tiny Stretches
- Here and Now Awareness
- Dolphin Pose Mothers were asked to choose the most suitable time of the day for the baby and herself, to have the baby fed at least 45 minutes before yoga, and to practice in a calm and dim environment, listening to music or white noise of her choice. Approximately one yoga session is 20 minutes.
Control group: Left for routine care. Stage 3: All babies and their mothers were followed up once a week for 4 weeks, a total of 4 times. Postnatal Breastfeeding Self-Efficacy Scale-Short Form, Mother-Infant Attachment Scale, and Sleep Diary were administered to mothers at each follow-up.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- The study is of the randomized controlled type.
| Arm | Type | Receives |
|---|---|---|
| İntervention | Experimental | Behavioral: mother baby yogaIntervention Group: A mother-baby yoga video prepared by the researchers was sent to the mothers in the intervention group. Before the mothers yoga practice, a 10-minute training was given about mother-baby yoga. Mothers were asked to do yoga at least 3 times a week for 4 weeks. Counseling and follow-up of the process were carried out by a researcher by calling the mothers once a week. Mothers were asked to choose the most suitable time of the day for the baby and herself, to have the baby fed at least 45 minutes before yoga, and to practice in a calm and dim environment, listening to music or white noise of her choice. Approximately one yoga session is 20 minutes. It was monitored once a week for 4 weeks, a total of 4 times. Postnatal Breastfeeding Self-Efficacy Scale-Short Form, Mother-Infant Attachment Scale, and Sleep Diary were administered to mothers at each follow-up. |
| Control | No intervention | –Data Collection Form, Postnatal Breastfeeding Self-Efficacy Scale-Short Form, Mother-Infant Attachment Scale, and Sleep Diary were administered to mothers.It was monitored once a week for 4 weeks, a total of 4 times. Postnatal Breastfeeding Self-Efficacy Scale-Short Form, Mother-Infant Attachment Scale, and Sleep Diary were administered to mothers at each follow-up. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Babies born at term (37-40 weeks of gestation)
- In the first postpartum week,
- Healthy and singleton newborns were included.
Key exclusion criteria (5 listed)
- Babies staying in the postnatal intensive care unit,
- The mother has a physical disability,
- The mother has a psychiatric illness,
- Being pregnant using assisted reproductive techniques,
- Not included if the mother or baby has a disability related to breastfeeding
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 |
|---|---|---|
| mother baby yogaYoga Video Content Plan * Mood Regulation: Abdominal/Belly Breathing * Warm Touch from the Heart * Chair Posture * Bucket Wrapping * Bukka Bukka (Heart) * Vortex Generation * Fertile Falls * One Hand Two Hands * Tiny Stretches * Here and Now Awareness * Dolphin Pose Mothers were asked to choose the most suitable time of the day for the baby and herself, to have the baby fed at least 45 minutes before yoga, and to practice in a calm and dim environment, listening to music or white noise of her choice. Approximately one yoga session is 20 minutes. | Behavioural | İntervention |
Primary outcome
Maternal Attecment
Time frame: 16 weeks
Attachment level was measured with the Mother-Infant Attachment
2 secondary outcomes
Baby Sleep
Time frame: 16 weeks
Breastfeeding Self-Efficacy
Time frame: 16 Weeks
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 22 Jan 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mother baby yoga in people with Maternal Behavior and Maternal Care Patterns, 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 5 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 22 Jan 2024. 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?
Maternal Attecment (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jan 2024.