Mother-Infant InteractionNCT06202937
The Effect of Mother-Baby Yoga Baby Perception, Maternal Attachment,Depression-Anxiety-Stress
A study testing Mother Baby Yoga in people with Mother-Infant Interaction, run by Hasan Kalyoncu University at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 4 monthsHealthy volunteers can take part
- Conditions the study is for
- Mother-Infant Interaction
- 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
- 60 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 2 Aug 2023to 2 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 2 to 4 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Emine Sarıkamış Kale
Batman, Merkez, 72000
Hasan Kalyoncu University
Gaziantep, Şahinbey
About this study
Official title: The Effect of Mother-Baby Yoga on Fragile Baby Perception Syndrome, Maternal Attachment, Depression-Anxiety-Stress in Mothers
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.
Read the detailed description
The World Health Organization (WHO) defines preterm newborns as babies born alive before completing the 37th week of gestation, regardless of birth weight. While the preterm birth rate in the world is 10%, the preterm rate in live births in our country in 2021 has increased compared to previous years and has been determined as 12.2%. Preterm babies account for 35% of neonatal deaths worldwide. According to WHO, approximately 15 million babies are born preterm every year. Complications arising from preterm birth are the leading cause of mortality among children under 5 years of age. Again, according to WHO, 16% of neonatal (0-27 days) deaths are caused by preterm birth.Preterm babies face many problems at home after discharge. It is reported in the literature that preterm babies need special care after birth, that they may need to stay in the neonatal intensive care unit (NICU) for a long time, and that babies' stay in the hospital or NICU is traumatic for families . In a study comparing the parenting competencies of families with a preterm baby at home with the parenting competencies of families with a term baby, it was reported that parents with a preterm baby were less self-confident and preferred to watch as spectators rather than actively participating in the baby's care . In the study titled Permanent Postnatal Depression After Preterm Birth conducted by Kukreja et al., it was determined that postpartum psychological distress and stress continued in mothers who gave birth preterm in the 6th week after birth.As a result of the preterm baby being hospitalized in the NICU, the mother's separation from her baby and her inability to give him the care he desires increases anxiety and stress in the mother. The mother, who feels guilty for giving birth to her baby early, sees herself as inadequate and feels a lack of self-confidence and cannot pay enough attention to her baby. The stress experienced by mothers in the first days also negatively affects the mother-infant relationship and maternal attachment . Stressful situations that negatively affect attachment can also increase the risk of anxiety and depression in the mother. A mother's loving attachment to her baby is one of the most important elements that affects the healthy development of the child. If a secure attachment cannot be established between mother and baby, the risk of developing emotional, social, physical and mental problems in the baby increases. The healthier the mother's communication and interaction with her baby in the early period; The faster the feeling of motherhood will develop. Additionally, the mother's anxiety, stress and fear will decrease .
Another problem experienced in preterm babies is that the mother, who gave birth before completing the pregnancy process, may fear losing her baby at any time after being discharged from home . The mother may not touch her baby, thinking that it will harm her, or she may delay this process and make it difficult to participate in the baby's care. These situations cause mothers to have difficulties in their relationship with their preterm babies and in baby care, and Fragile Baby Syndrome, defined by mothers as sensitive babies, may develop.One of the practices that will support the mother and baby during this period is yoga practice. Yoga is the oldest system in the world that emphasizes the importance of body, mind and spiritual balance in human development. Yoga, although mostly seen as a physical pursuit, is also a physio-psychological and psycho-spiritual subject; It is a teaching that ensures the mental, emotional and spiritual maturation of individuals along with physical maturation. When yoga is practiced in a disciplined manner, it enables the individual to become aware of his soul by connecting with his body and mind. Yoga is a practice that not only reduces stress but can also direct one's emotions and thoughts. Instead of questioning the negative experiences of the person, they accept them as they are and help them cope. Yoga has a very important place in supporting mother-baby communication after birth. It has been seen in the literature review that yoga is generally good for a person's psychological health and has a positive effect on self-efficacy . It is known that this practice enables mothers to intuitively be in close contact with their bodies and emotions . In line with the studies conducted, mother-baby yoga practice; helps the woman adapt to the changes occurring in her body, during meditation.This is due to the fact that she communicates spiritually with her baby by touching her baby and making eye contact.It is thought that it may contribute to mother-infant bonding and change in the mother's perception of her baby, as a result of being able to cope with physiological and psychological stressors. It also has positive effects on the baby, such as increased growth and development, regular sleep, reduced stress, sensory, motor, mental and social development and many more.
The aim of the research was planned to consider the positive benefits of yoga for mothers and babies who had preterm birth and were discharged, and to examine its effect on depression, anxiety, stress level, mother-infant attachment levels and mothers' perception of fragility.
- Conditions
- Mother-Infant Interaction
- Being tested
- Mother Baby Yoga, No intervention:control
- Keywords
- Mother-Baby Yoga, Fragile Baby Perception Syndrome, Maternal Attachment, Depression-Anxiety-Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mother Baby YogaBehavioural
Fragile Baby Perception Syndrome, Maternal Attachment, Depression-Anxiety-Stress Level
No intervention:controlOther
the control group received the usual care
| Study group | Role | What they receive |
|---|---|---|
| mother baby yoga | Experimental | Mother-baby yoga will be held with the babies discharged from the neonatal intensive care unit and their mothers Receives: Behavioral: Mother Baby Yoga |
| control | Experimental | the control group received the usual care Receives: Other: No intervention:control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 8 weeks
Depression, Anxiety, Stress Scale (DASS-21
0-3 point each item min 0 max 21 total point each subscale
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start2 Aug 2023
- Primary completion30 Nov 2023
- Study completion2 Dec 2023
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 Mother-Infant InteractionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, EMİNE SARIKAMIŞ KALE, Hasan Kalyoncu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06202937
- Sponsor's protocol ID
- 2023/64
- Status last verified
- Dec 2025
- First submitted
- 2 Jan 2024
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40749378
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mother-Baby Yoga on Fragile Baby Perception Syndrome, Maternal Attachment, Depression-Anxiety-Stress in Mothers
- ClinicalTrials.gov ID
- NCT06202937
- Acronym / sponsor ID
- 2023/64
- Conditions
- Mother-Infant Interaction
- Keywords
- Mother-Baby Yoga, Fragile Baby Perception Syndrome, Maternal Attachment, Depression-Anxiety-Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Study start
- 2 Aug 2023 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 2 Dec 2023 (actual)
- First posted
- 12 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 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.
Detailed description
The World Health Organization (WHO) defines preterm newborns as babies born alive before completing the 37th week of gestation, regardless of birth weight. While the preterm birth rate in the world is 10%, the preterm rate in live births in our country in 2021 has increased compared to previous years and has been determined as 12.2%. Preterm babies account for 35% of neonatal deaths worldwide. According to WHO, approximately 15 million babies are born preterm every year. Complications arising from preterm birth are the leading cause of mortality among children under 5 years of age. Again, according to WHO, 16% of neonatal (0-27 days) deaths are caused by preterm birth.Preterm babies face many problems at home after discharge. It is reported in the literature that preterm babies need special care after birth, that they may need to stay in the neonatal intensive care unit (NICU) for a long time, and that babies' stay in the hospital or NICU is traumatic for families . In a study comparing the parenting competencies of families with a preterm baby at home with the parenting competencies of families with a term baby, it was reported that parents with a preterm baby were less self-confident and preferred to watch as spectators rather than actively participating in the baby's care . In the study titled Permanent Postnatal Depression After Preterm Birth conducted by Kukreja et al., it was determined that postpartum psychological distress and stress continued in mothers who gave birth preterm in the 6th week after birth.As a result of the preterm baby being hospitalized in the NICU, the mother's separation from her baby and her inability to give him the care he desires increases anxiety and stress in the mother. The mother, who feels guilty for giving birth to her baby early, sees herself as inadequate and feels a lack of self-confidence and cannot pay enough attention to her baby. The stress experienced by mothers in the first days also negatively affects the mother-infant relationship and maternal attachment . Stressful situations that negatively affect attachment can also increase the risk of anxiety and depression in the mother. A mother's loving attachment to her baby is one of the most important elements that affects the healthy development of the child. If a secure attachment cannot be established between mother and baby, the risk of developing emotional, social, physical and mental problems in the baby increases. The healthier the mother's communication and interaction with her baby in the early period; The faster the feeling of motherhood will develop. Additionally, the mother's anxiety, stress and fear will decrease .
Another problem experienced in preterm babies is that the mother, who gave birth before completing the pregnancy process, may fear losing her baby at any time after being discharged from home . The mother may not touch her baby, thinking that it will harm her, or she may delay this process and make it difficult to participate in the baby's care. These situations cause mothers to have difficulties in their relationship with their preterm babies and in baby care, and Fragile Baby Syndrome, defined by mothers as sensitive babies, may develop.One of the practices that will support the mother and baby during this period is yoga practice. Yoga is the oldest system in the world that emphasizes the importance of body, mind and spiritual balance in human development. Yoga, although mostly seen as a physical pursuit, is also a physio-psychological and psycho-spiritual subject; It is a teaching that ensures the mental, emotional and spiritual maturation of individuals along with physical maturation. When yoga is practiced in a disciplined manner, it enables the individual to become aware of his soul by connecting with his body and mind. Yoga is a practice that not only reduces stress but can also direct one's emotions and thoughts. Instead of questioning the negative experiences of the person, they accept them as they are and help them cope. Yoga has a very important place in supporting mother-baby communication after birth. It has been seen in the literature review that yoga is generally good for a person's psychological health and has a positive effect on self-efficacy . It is known that this practice enables mothers to intuitively be in close contact with their bodies and emotions . In line with the studies conducted, mother-baby yoga practice; helps the woman adapt to the changes occurring in her body, during meditation.This is due to the fact that she communicates spiritually with her baby by touching her baby and making eye contact.It is thought that it may contribute to mother-infant bonding and change in the mother's perception of her baby, as a result of being able to cope with physiological and psychological stressors. It also has positive effects on the baby, such as increased growth and development, regular sleep, reduced stress, sensory, motor, mental and social development and many more.
The aim of the research was planned to consider the positive benefits of yoga for mothers and babies who had preterm birth and were discharged, and to examine its effect on depression, anxiety, stress level, mother-infant attachment levels and mothers' perception of fragility.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mother baby yoga | Experimental | Behavioral: Mother Baby YogaMother-baby yoga will be held with the babies discharged from the neonatal intensive care unit and their mothers |
| control | Experimental | Other: No intervention:controlthe control group received the usual care |
Who may qualify
- Ages
- 2 to 4 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (13 listed)
- 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,
Key exclusion criteria (3 listed)
- Their baby has a genetic disease or congenital disorder,
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 YogaFragile Baby Perception Syndrome, Maternal Attachment, Depression-Anxiety-Stress Level | Behavioural | mother baby yoga |
| No intervention:controlthe control group received the usual care | Other | control |
Primary outcome
Fragile Infant Perception Scale
Time frame: 8 weeks
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.
Maternal Attachment Scale
Time frame: 8 weeks
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.
Depression, Anxiety, Stress Scale (DASS-21
Time frame: 8 weeks
0-3 point each item min 0 max 21 total point each subscale
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 10 Dec 2025.
- Derived from this study: PubMed 40749378Koc 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.
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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.
2 sites 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 Mother-Infant Interaction, run by Hasan Kalyoncu University at 2 sites 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 13 inclusion and 3 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 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Fragile Infant Perception Scale (time frame: 8 weeks). The study lists 3 primary outcomes in all. 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 NCT06202937, 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 10 Dec 2025.