NewbornNCT06269458
The Effects of Mother-Baby Yoga and Baby Massage on Attachment and Sleep
A study testing Baby Massage and Monther-Baby Yoga in people with Newborn and Yoga, run by Antalya Bilim University at 1 site in Turkey (Türkiye).
Trial summary
Purpose: This study was conducted to examine the effects of mother-baby yoga and massage on mother-baby bonding and the baby's sleep. Method: A randomised, crossover pilot study was conducted in the postpartum service of a hospital between January and November 2023, with 60 mothers and their babies in the postpartum… Read more about this study
- Who is it for?
- Ages 0 to 5 daysHealthy volunteers can take part
- Conditions the study is for
- Newborn, Yoga, Mother-Infant Interaction
- What is being tested?
- Baby Massage and Monther-Baby Yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 26 Dec 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 0 to 5 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Babies in the first week of postpartum
- Healthy babies,
- Therm (37-40 W),
- The baby should be at normal birth weight (2500-4000gr),
- Mothers who know how to read and writ
Who cannot join
- Mothers with communication problems,
- Individuals whose mother or baby are monitored in intensive care after birth
- If the mother has a physical disability or any chronic disease (hypertension, diabetes mellitus, etc.),
- Psychological illness in the mother (major depression, psychosis, etc.),
- Pregnancy through assisted reproductive techniques,
- Mothers who are diagnosed with a sleep disorder and who have their babies treated for this reason.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Mother-Baby Yoga and Baby Massage on Attachment and Sleep: A Randomized Crossover Pilot Study
Purpose: This study was conducted to examine the effects of mother-baby yoga and massage on mother-baby bonding and the baby's sleep.
Method: A randomised, crossover pilot study was conducted in the postpartum service of a hospital between January and November 2023, with 60 mothers and their babies in the postpartum period, 30 in each group. To the mothers and their babies included in the research, baby massage was applied to one group and mother-baby yoga was applied to the other. After four weeks, the groups' practices were changed. In the results of the research, characteristics related to attachment and sleep were evaluated.
- Conditions
- Newborn, Yoga, Mother-Infant Interaction, Sleep
- Being tested
- Baby Massage, Monther-Baby Yoga
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baby MassageBehavioural
In the baby massage application, mothers were trained on baby massage and the massage applied by the mother to her baby was observed once. The baby massage video prepared by the researchers was shared with mothers. Mothers were informed about the importan
Monther-Baby YogaBehavioural
Mothers were asked to choose the most suitable time of day for themselves and the baby, to ensure that the baby was fed at least 45 minutes before yoga, and to practice yoga in a calm and dimly lit environment, listening to music or white noise of their choice. One yoga session lasted approximately 20 minutes. Mothers and their babies did mother-baby yoga three times a week for four weeks. Mothers were informed about the importance of having the same treatment room for each treatment. All mothers were called once a week by a researcher to provide counseling and follow-up of the process.
At the end of four weeks, measurement tools were applied to all mothers and the groups were changed, massage was applied to the yoga group, and yoga intervention was applied to the massage group, as in the beginning of the research. At the end of four weeks, all mothers were evaluated for mother-infant attachment and the infant's sleep diary.
| Study group | Role | What they receive |
|---|---|---|
| Baby Massage | Experimental | In the baby massage application, mothers were trained on baby massage and the massage applied by the mother to her baby was observed once. The baby massage video prepared by the researchers was shared with mothers. Baby massage application was performed 90 minutes after feeding and each application was performed at the same time. Mothers massaged their babies for 15 minutes three times a week for a month. The Massage Application Content included one minute face, two minutes chest, four minutes arm, two minutes abdominal, four minutes leg and two minutes back massage (Virgian and Setiawati, 2021; Yenigün 2020; Yılmaz, 2019). All mothers were called once a week by a researcher to provide counseling and follow-up of the process.
At the end of four weeks, measurement tools were applied to all mothers and the groups were changed, massage was applied to the yoga group, and yoga intervention was applied to the massage group, as in the beginning of the research. Receives: Behavioral: Baby Massage |
| Mother-Baby Yoga | Experimental | The mothers in the Mother-Baby Yoga group were given a 10-minute training on mother-baby yoga before the application, and then a session was applied together. Mothers were asked to choose the most suitable time of day for themselves and the baby, to ensure that the baby was fed at least 45 minutes before yoga, and to practice yoga in a calm and dimly lit environment, listening to music or white noise of their choice. One yoga session lasted approximately 20 minutes. Mothers and their babies did mother-baby yoga three times a week for four weeks. Mother baby yoga content; Mood regulation: belly breathing, warm touch from the heart, chair pose, scoop hug, bukka bukka, vortex creation, lush falls one hand two hands, tiny stretches, here and now awareness and dolphin pose. Receives: Behavioral: Monther-Baby Yoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attachment
The Mother-Infant Attachment Scale developed by Taylor et al. was used to measure mother-infant attachment. The Turkish validity and reliability study of the scale was conducted by (Karakulak et al., 2016). The MIBS is designed to be administered from the first day after birth and allows the mother to express her feelings towards her baby with a single word. This scale, which can be easily and quickly administered by the mother or father alone, shows the relationship between the established bond and the mother's early mood.
Measured: It was applied before and after the intervention (4 weeks).
Weight and Sleep
Sleep characteristics of the infants were assessed using a sleep diary form created by the researchers. The form included questions about the time of starting the bedtime routine, the time of going to bed, the number of nighttime awakenings, the duration of staying awake at night, the longest sleep time spent without waking up at night, the total sleep time at night, the number of daytime naps, and the total sleep time during the day (Ağapınar et al., 2023; Del-Ponte et al., 2020; Hanifarizani et al., 2020; Mrljak et al., 2022). The mothers were asked to write in this diary to be recorded for one day during the first and last week of the implementation process.
Measured: It was applied before and after the intervention (4 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start1 Jan 2023
- Primary completion25 Nov 2023
- Study completion26 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NewbornStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antalya Bilim University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06269458
- Sponsor's protocol ID
- ABU-001
- Status last verified
- Feb 2024
- First submitted
- 5 Feb 2024
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study will be shared after it is published.
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Mother-Baby Yoga and Baby Massage on Attachment and Sleep: A Randomized Crossover Pilot Study
- ClinicalTrials.gov ID
- NCT06269458
- Acronym / sponsor ID
- ABU-001
- Conditions
- Newborn, Yoga, Mother-Infant Interaction, Sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Antalya Bilim UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 25 Nov 2023 (actual)
- Study completion
- 26 Dec 2023 (actual)
- First posted
- 21 Feb 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.
Purpose: This study was conducted to examine the effects of mother-baby yoga and massage on mother-baby bonding and the baby's sleep.
Method: A randomised, crossover pilot study was conducted in the postpartum service of a hospital between January and November 2023, with 60 mothers and their babies in the postpartum period, 30 in each group. To the mothers and their babies included in the research, baby massage was applied to one group and mother-baby yoga was applied to the other. After four weeks, the groups' practices were changed. In the results of the research, characteristics related to attachment and sleep were evaluated.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baby Massage | Experimental | Behavioral: Baby MassageIn the baby massage application, mothers were trained on baby massage and the massage applied by the mother to her baby was observed once. The baby massage video prepared by the researchers was shared with mothers. Baby massage application was performed 90 minutes after feeding and each application was performed at the same time. Mothers massaged their babies for 15 minutes three times a week for a month. The Massage Application Content included one minute face, two minutes chest, four minutes arm, two minutes abdominal, four minutes leg and two minutes back massage (Virgian and Setiawati, 2021; Yenigün 2020; Yılmaz, 2019). All mothers were called once a week by a researcher to provide counseling and follow-up of the process. At the end of four weeks, measurement tools were applied to all mothers and the groups were changed, massage was applied to the yoga group, and yoga intervention was applied to the massage group, as in the beginning of the research. |
| Mother-Baby Yoga | Experimental | Behavioral: Monther-Baby YogaThe mothers in the Mother-Baby Yoga group were given a 10-minute training on mother-baby yoga before the application, and then a session was applied together. Mothers were asked to choose the most suitable time of day for themselves and the baby, to ensure that the baby was fed at least 45 minutes before yoga, and to practice yoga in a calm and dimly lit environment, listening to music or white noise of their choice. One yoga session lasted approximately 20 minutes. Mothers and their babies did mother-baby yoga three times a week for four weeks. Mother baby yoga content; Mood regulation: belly breathing, warm touch from the heart, chair pose, scoop hug, bukka bukka, vortex creation, lush falls one hand two hands, tiny stretches, here and now awareness and dolphin pose. |
Who may qualify
- Ages
- 0 to 5 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Babies in the first week of postpartum
- Healthy babies,
- Therm (37-40 W),
- The baby should be at normal birth weight (2500-4000gr),
- Mothers who know how to read and writ
Key exclusion criteria (6 listed)
- Mothers with communication problems,
- Individuals whose mother or baby are monitored in intensive care after birth
- If the mother has a physical disability or any chronic disease (hypertension, diabetes mellitus, etc.),
- Psychological illness in the mother (major depression, psychosis, etc.),
- Pregnancy through assisted reproductive techniques,
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 |
|---|---|---|
| Baby MassageIn the baby massage application, mothers were trained on baby massage and the massage applied by the mother to her baby was observed once. The baby massage video prepared by the researchers was shared with mothers. Mothers were informed about the importan | Behavioural | Baby Massage |
| Monther-Baby YogaMothers were asked to choose the most suitable time of day for themselves and the baby, to ensure that the baby was fed at least 45 minutes before yoga, and to practice yoga in a calm and dimly lit environment, listening to music or white noise of their choice. One yoga session lasted approximately 20 minutes. Mothers and their babies did mother-baby yoga three times a week for four weeks. Mothers were informed about the importance of having the same treatment room for each treatment. All mothers were called once a week by a researcher to provide counseling and follow-up of the process. At the end of four weeks, measurement tools were applied to all mothers and the groups were changed, massage was applied to the yoga group, and yoga intervention was applied to the massage group, as in the beginning of the research. At the end of four weeks, all mothers were evaluated for mother-infant attachment and the infant's sleep diary. | Behavioural | Mother-Baby Yoga |
Primary outcome
Attachment
Time frame: It was applied before and after the intervention (4 weeks).
The Mother-Infant Attachment Scale developed by Taylor et al. was used to measure mother-infant attachment. The Turkish validity and reliability study of the scale was conducted by (Karakulak et al., 2016). The MIBS is designed to be administered from the first day after birth and allows the mother to express her feelings towards her baby with a single word. This scale, which can be easily and quickly administered by the mother or father alone, shows the relationship between the established bond and the mother's early mood.
Weight and Sleep
Time frame: It was applied before and after the intervention (4 weeks).
Sleep characteristics of the infants were assessed using a sleep diary form created by the researchers. The form included questions about the time of starting the bedtime routine, the time of going to bed, the number of nighttime awakenings, the duration of staying awake at night, the longest sleep time spent without waking up at night, the total sleep time at night, the number of daytime naps, and the total sleep time during the day (Ağapınar et al., 2023; Del-Ponte et al., 2020; Hanifarizani et al., 2020; Mrljak et al., 2022). The mothers were asked to write in this diary to be recorded for one day during the first and last week of the implementation process.
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 21 Feb 2024.
- Individual participant dataSharing planned: No. The study will be shared after it is published.
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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 Baby Massage and Monther-Baby Yoga in people with Newborn and Yoga, run by Antalya Bilim 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 5 inclusion and 6 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 21 Feb 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?
Attachment (time frame: It was applied before and after the intervention (4 weeks).). The study lists 2 primary outcomes in all. 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 21 Feb 2024.