GrowthNCT05302427
Infant Massage and Infant Growth, Mother-Infant Attachment, and Maternal Self-Confidence
A study testing Infant Massage in people with Growth and Attachment, run by Bandırma Onyedi Eylül University at 2 sites in Turkey (Türkiye).
Trial summary
Touch is an essential element in the healthy growth and development of the baby. Infant massage is the best way to touch babies. In line with the literature review on the subject, it has been reported that infant massage supports growth and development in infants, improves attachment between mothers and babies and… Read more about this study
- Who is it for?
- Ages 4 to 4 weeks
- Conditions the study is for
- Growth, Attachment, Self-Confidence
- What is being tested?
- Infant Massage
- 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
- 29 Nov 2021to 17 Jun 2022
- 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 4 to 4 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The mother knows how to read, write and use a computer,
- The mother's consent to participate in the study,
- Babies 38-42. to be born at the gestational week and to have a birth weight of over 2500 grams and to have completed the fourth week.
Who cannot join
- Multiple pregnancy
- The mother has a disease or disability that prevents her from massaging her baby.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Karşıyaka 4 No'lu Bostanlı- 2 Aile Sağlığı Merkezi
Izmir, Karşıyaka
Karşıyaka 8 Nolu Gülay Kaymak Aile Sağlığı Merkezi
Izmir, Karşıyaka
About this study
Official title: The Effect of Infant Massage on Infant Growth, Mother-Infant Attachment, and Maternal Self-Confidence
Touch is an essential element in the healthy growth and development of the baby. Infant massage is the best way to touch babies. In line with the literature review on the subject, it has been reported that infant massage supports growth and development in infants, improves attachment between mothers and babies and decreases the level of depression and anxiety in mothers.
With the coronavirus pandemic, quarantine decisions have been implemented all over the world. In addition to the stress brought on by their new roles, new mothers have to cope with the anxiety and stress of being a parent and babysitting during the pandemic period. During the pandemic process, it is seen that depression and anxiety levels increase in mothers who have given birth, and maternal attachment is negatively affected. Depression and anxiety in mothers negatively affect the cognitive, physical, social and emotional development of babies. It is very important to encourage practices that increase mother-infant interaction, such as infant massage, during the pandemic period.
The universe of the research will consist of mothers and their babies who were followed up in İzmir Karşıyaka No. 8 Gülay Kaymak Family Health Center and Karşıyaka No. 4 Bostanlı-2 Family Health Center between May 2021 and May 2022. The sample of the study is 38-42. It is planned to create babies born in the 4th week of pregnancy, with a birth weight of over 2500 grams and who have completed their fourth week (one month old) (n:60).
Read the detailed description
The sense of touch is the most developed sense in newborns and is very important in perceiving the environment. The sense of touch in newborn babies is well developed throughout the body, especially on the tongue, lips, ears and forehead. When the baby is touched and held, he communicates with his environment and caregiver, and begins to recognize his environment. The sense of touch also positively affects the psychosocial development of babies. Infant massage is the best way to touch the baby. In recent years, research on infant massage has been the focus of the literature. When the literature is examined; it is seen that the positive effects of baby massage that support the growth and development of babies are proven by scientific research.
Attachment is defined as a situation that begins with the birth of the baby and has a predominant emotional aspect. The basic sense of trust formed between the mother and the baby in the early stages of life supports the psychosocial development of the baby. Touch, which is an effective method in providing and developing the interaction between the baby and the mother, affects the attachment positively. Infant massage is one of the easiest and most natural ways to develop mother-infant attachment. Studies show that infant massage strengthens the attachment between mothers and babies.
Baby massage also increases the mother's self-confidence in baby care. In the postpartum period, parents enter a new period in which they have to adapt to new roles, deal with baby care and the problems they experience with the baby. This period can sometimes cause problems such as lack of self-confidence, stress, anxiety and fear in mothers. The fear, anxiety and stress experienced by mothers regarding infant care can negatively affect mother-infant attachment. When the studies were examined, it was reported that the self-confidence score of the mothers who massaged was higher than the mothers in the control group in the study of with low birth weight babies and their mothers. In the qualitative study, mothers who apply baby massage defined massage as "a relaxing practice that provides emotional and physical contact with their babies". In addition, mothers stated that massage increased their self-confidence regarding the role of motherhood.
A newborn baby is born with about 100 billion neurons. Connections begin to form between neurons in the brain, especially in the first year after birth. While connections are formed with the warnings and experiences they receive throughout their lives; Neurons that do not receive enough stimulation die because they cannot make new connections. In babies who are given positive stimuli, intercellular connections are intense and their intelligence levels are positively affected. During the first two years of life, the rate of development of connections between neurons is quite high. Infant massage applied in these years contributes to the strengthening of the nervous system. The brain development of babies who are deprived of physical contact is adversely affected. Therefore, touch is an indispensable element in both the physical growth and development of the baby and the brain development.
In Turkey, no training is given on infant massage in family health centers. However, the positive effects of massage on babies and mothers have been demonstrated by scientific research. The role of nurses in mother-infant interaction is very important, making applications that support mother-infant interaction in the postpartum period and guiding mothers in this process is an important nursing practice. While nurses are training mothers, they should provide infant massage training within infant care routines, counsel mothers on infant massage and encourage them.
This study was designed in a randomized controlled, pre-test-post-test experimental model to examine the effects of infant massage on growth, mother-infant attachment, and mothers' self-confidence.
- Conditions
- Growth, Attachment, Self-Confidence
- Being tested
- Infant Massage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infant MassageBehavioural
The training will start with a leg massage in the first session and the mother will be asked to do this once a day until the next lesson. The next week, the new massage movement will be shown to the mother and the training will continue, and the mother will be told to do the application throughout the week by integrating it with the previous movement this time, and the four-week training will be completed in this way. After the training, which massage movement was taught to the mothers every week, the application pictures of this part will be sent and at the end of the four-week training, the baby massage video and the baby massage guide will be sent to the mothers by e-mail.
| Study group | Role | What they receive |
|---|---|---|
| Massage group | Experimental | The massage group will be shown live one-to-one baby massage training via Microsoft Teams by the researcher, and the mother will be asked to apply it to her baby at the same time. Baby massage training; It consists of leg massage, face-abdominal massage, arm-chest massage and back massage and will be completed in four weeks. Receives: Behavioral: Infant Massage |
| Control group | No intervention | Infant massage training will not be given to the mothers of the babies in the control group until the 20th week. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal Attachment Inventory (MAI)
The MAI is a 26-item self-report questionnaire used to measure mother-child attachment. Each item represents a maternal activity (e.g. 'I tell others about my baby') or feeling (e.g. 'I feel love for my child') which indicates affection towards the child. Items are scored on a 4-point Likert scale ranging from 1 (almost never)-4 (almost always). Total MAI scores range from 26-104, with higher scores indicating greater maternal attachment. The mean score of mother attachment inventory (pre-intervention assessment)
Measured: end of week 4
Maternal Attachment Inventory (MAI)
The MAI is a 26-item self-report questionnaire used to measure mother-child attachment. Each item represents a maternal activity (e.g. 'I tell others about my baby') or feeling (e.g. 'I feel love for my child') which indicates affection towards the child. Items are scored on a 4-point Likert scale ranging from 1 (almost never)-4 (almost always). Total MAI scores range from 26-104, with higher scores indicating greater maternal attachment. The mean score of mother attachment inventory (post-intervention assessment)
Measured: end of week 20
Growth Parameter
The mean of baseline weight (in grams)
Measured: end of week 4
Growth Parameter
The mean change in body weight from end of week 4 to end of week 8 (in grams)
Measured: end of week 8
Growth Parameter
The mean change in body weight from end of week 8 to end of week 12 (in grams)
Measured: end of week 12
Growth Parameter
The mean change in body weight from end of week 12 to week end of 16 (in grams)
Measured: end of week 16
Growth Parameter
The mean change in body weight from end of week 16 to week end of 20 (in grams)
Measured: end of week 20
Growth Parameter
The mean of baseline body length (in centimeters)
Measured: end of week 4
Growth Parameter
The mean change in body length from end of week 4 to end of week 8 (in centimeters)
Measured: end of week 8
Growth Parameter
The mean change in body length from end of week 8 to end of week 12 (in centimeters)
Measured: end of week 12
Growth Parameter
The mean change in body length from end of week 12 to end of week 16 (in centimeters)
Measured: end of week 16
Growth Parameter
The mean change in body length from end of week 16 to end of week 20 (in centimeters)
Measured: end of week 20
Head circumference
The mean of baseline head circumference (in centimeters)
Measured: end of week 4
Head circumference
The mean change in head circumference from end of week 4 to end of week 8 (in centimeters)
Measured: end of week 8
Head circumference
The mean change in head circumference from end of week 8 to end of week 12 (in centimeters)
Measured: end of week 12
Head circumference
The mean change in head circumference from end of week 12 to end of week 16 (in centimeters)
Measured: end of week 16
Head circumference
The mean change in head circumference from end of week 16 to end of week 20 (in centimeters)
Measured: end of week 20
Secondary outcomes (2)
Pharis Self-Confidence
The Pharis Self-Confidence Scale, which is a 13-item five-point measurement tool, measures a parent's feelings of self-confidence about daily baby care. Each infant care item is rated from 1 to 5 (not at all, very little, moderately, very much, completely). The increase in the total score obtained from the scale indicates that the self-confidence levels of the mothers increase in baby care. The lowest score on the "Pharis Self-Confidence" scale is 13, the highest score is 65.The mean score of pharis self-confidence (pre-intervention assessment)
Measured: end of week 4
Pharis Self-Confidence
The Pharis Self-Confidence Scale, which is a 13-item five-point measurement tool, measures a parent's feelings of self-confidence about daily baby care. Each infant care item is rated from 1 to 5 (not at all, very little, moderately, very much, completely). The increase in the total score obtained from the scale indicates that the self-confidence levels of the mothers increase in baby care. The lowest score on the "Pharis Self-Confidence" scale is 13, the highest score is 65.The mean score of pharis self-confidence (pre-intervention assessment)
Measured: end of week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start29 Nov 2021
- Primary completion30 Nov 2021
- Study completion17 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for GrowthStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bandırma Onyedi Eylül University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zubeyde Ezgi Ercelik, Bandırma Onyedi Eylül University
- Investigators
- Zübeyde Ezgi ERCELIK, MSc, Study chair, Bandırma Onyedi Eylül UniversityHatice BAL YILMAZ, Proffessor, Principal investigator, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05302427
- Sponsor's protocol ID
- 21-5.1t/53
- Status last verified
- Jun 2022
- First submitted
- 11 Mar 2022
- Last updated
- 30 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vicente S, Verissimo M, Diniz E. Infant massage improves attitudes toward childbearing, maternal satisfaction and pleasure in parenting. Infant Behav Dev. 2017 Nov;49:114-119. doi: 10.1016/j.infbeh.2017.08.006. Epub 2017 Sep 1.
PubMed 28866286Gurol A, Polat S. The Effects of Baby Massage on Attachment between Mother and their Infants. Asian Nurs Res (Korean Soc Nurs Sci). 2012 Mar;6(1):35-41. doi: 10.1016/j.anr.2012.02.006. Epub 2012 Mar 10.
PubMed 25030689Lu LC, Lan SH, Hsieh YP, Lin LY, Chen JC, Lan SJ. Massage therapy for weight gain in preterm neonates: A systematic review and meta-analysis of randomized controlled trials. Complement Ther Clin Pract. 2020 May;39:101168. doi: 10.1016/j.ctcp.2020.101168. Epub 2020 Apr 1.
PubMed 32379694Ercelik ZE, Yilmaz HB. Effectiveness of infant massage on babies growth, mother-baby attachment and mothers' self-confidence: A randomized controlled trial. Infant Behav Dev. 2023 Nov;73:101897. doi: 10.1016/j.infbeh.2023.101897. Epub 2023 Nov 6.
PubMed 37939520
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Infant Massage on Infant Growth, Mother-Infant Attachment, and Maternal Self-Confidence
- ClinicalTrials.gov ID
- NCT05302427
- Acronym / sponsor ID
- 21-5.1t/53
- Conditions
- Growth, Attachment, Self-Confidence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Bandırma Onyedi Eylül UniversityUniversity, hospital or other
- Study start
- 29 Nov 2021 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 17 Jun 2022 (actual)
- First posted
- 31 Mar 2022 (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.
Touch is an essential element in the healthy growth and development of the baby. Infant massage is the best way to touch babies. In line with the literature review on the subject, it has been reported that infant massage supports growth and development in infants, improves attachment between mothers and babies and decreases the level of depression and anxiety in mothers.
With the coronavirus pandemic, quarantine decisions have been implemented all over the world. In addition to the stress brought on by their new roles, new mothers have to cope with the anxiety and stress of being a parent and babysitting during the pandemic period. During the pandemic process, it is seen that depression and anxiety levels increase in mothers who have given birth, and maternal attachment is negatively affected. Depression and anxiety in mothers negatively affect the cognitive, physical, social and emotional development of babies. It is very important to encourage practices that increase mother-infant interaction, such as infant massage, during the pandemic period.
The universe of the research will consist of mothers and their babies who were followed up in İzmir Karşıyaka No. 8 Gülay Kaymak Family Health Center and Karşıyaka No. 4 Bostanlı-2 Family Health Center between May 2021 and May 2022. The sample of the study is 38-42. It is planned to create babies born in the 4th week of pregnancy, with a birth weight of over 2500 grams and who have completed their fourth week (one month old) (n:60).
Detailed description
The sense of touch is the most developed sense in newborns and is very important in perceiving the environment. The sense of touch in newborn babies is well developed throughout the body, especially on the tongue, lips, ears and forehead. When the baby is touched and held, he communicates with his environment and caregiver, and begins to recognize his environment. The sense of touch also positively affects the psychosocial development of babies. Infant massage is the best way to touch the baby. In recent years, research on infant massage has been the focus of the literature. When the literature is examined; it is seen that the positive effects of baby massage that support the growth and development of babies are proven by scientific research.
Attachment is defined as a situation that begins with the birth of the baby and has a predominant emotional aspect. The basic sense of trust formed between the mother and the baby in the early stages of life supports the psychosocial development of the baby. Touch, which is an effective method in providing and developing the interaction between the baby and the mother, affects the attachment positively. Infant massage is one of the easiest and most natural ways to develop mother-infant attachment. Studies show that infant massage strengthens the attachment between mothers and babies.
Baby massage also increases the mother's self-confidence in baby care. In the postpartum period, parents enter a new period in which they have to adapt to new roles, deal with baby care and the problems they experience with the baby. This period can sometimes cause problems such as lack of self-confidence, stress, anxiety and fear in mothers. The fear, anxiety and stress experienced by mothers regarding infant care can negatively affect mother-infant attachment. When the studies were examined, it was reported that the self-confidence score of the mothers who massaged was higher than the mothers in the control group in the study of with low birth weight babies and their mothers. In the qualitative study, mothers who apply baby massage defined massage as "a relaxing practice that provides emotional and physical contact with their babies". In addition, mothers stated that massage increased their self-confidence regarding the role of motherhood.
A newborn baby is born with about 100 billion neurons. Connections begin to form between neurons in the brain, especially in the first year after birth. While connections are formed with the warnings and experiences they receive throughout their lives; Neurons that do not receive enough stimulation die because they cannot make new connections. In babies who are given positive stimuli, intercellular connections are intense and their intelligence levels are positively affected. During the first two years of life, the rate of development of connections between neurons is quite high. Infant massage applied in these years contributes to the strengthening of the nervous system. The brain development of babies who are deprived of physical contact is adversely affected. Therefore, touch is an indispensable element in both the physical growth and development of the baby and the brain development.
In Turkey, no training is given on infant massage in family health centers. However, the positive effects of massage on babies and mothers have been demonstrated by scientific research. The role of nurses in mother-infant interaction is very important, making applications that support mother-infant interaction in the postpartum period and guiding mothers in this process is an important nursing practice. While nurses are training mothers, they should provide infant massage training within infant care routines, counsel mothers on infant massage and encourage them.
This study was designed in a randomized controlled, pre-test-post-test experimental model to examine the effects of infant massage on growth, mother-infant attachment, and mothers' self-confidence.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Massage group | Experimental | Behavioral: Infant MassageThe massage group will be shown live one-to-one baby massage training via Microsoft Teams by the researcher, and the mother will be asked to apply it to her baby at the same time. Baby massage training; It consists of leg massage, face-abdominal massage, arm-chest massage and back massage and will be completed in four weeks. |
| Control group | No intervention | –Infant massage training will not be given to the mothers of the babies in the control group until the 20th week. |
Who may qualify
- Ages
- 4 to 4 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- The mother knows how to read, write and use a computer,
- The mother's consent to participate in the study,
- Babies 38-42. to be born at the gestational week and to have a birth weight of over 2500 grams and to have completed the fourth week.
Key exclusion criteria (2 listed)
- Multiple pregnancy
- The mother has a disease or disability that prevents her from massaging her baby.
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 |
|---|---|---|
| Infant MassageThe training will start with a leg massage in the first session and the mother will be asked to do this once a day until the next lesson. The next week, the new massage movement will be shown to the mother and the training will continue, and the mother will be told to do the application throughout the week by integrating it with the previous movement this time, and the four-week training will be completed in this way. After the training, which massage movement was taught to the mothers every week, the application pictures of this part will be sent and at the end of the four-week training, the baby massage video and the baby massage guide will be sent to the mothers by e-mail. | Behavioural | Massage group |
Primary outcome
Maternal Attachment Inventory (MAI)
Time frame: end of week 4
The MAI is a 26-item self-report questionnaire used to measure mother-child attachment. Each item represents a maternal activity (e.g. 'I tell others about my baby') or feeling (e.g. 'I feel love for my child') which indicates affection towards the child. Items are scored on a 4-point Likert scale ranging from 1 (almost never)-4 (almost always). Total MAI scores range from 26-104, with higher scores indicating greater maternal attachment. The mean score of mother attachment inventory (pre-intervention assessment)
Maternal Attachment Inventory (MAI)
Time frame: end of week 20
The MAI is a 26-item self-report questionnaire used to measure mother-child attachment. Each item represents a maternal activity (e.g. 'I tell others about my baby') or feeling (e.g. 'I feel love for my child') which indicates affection towards the child. Items are scored on a 4-point Likert scale ranging from 1 (almost never)-4 (almost always). Total MAI scores range from 26-104, with higher scores indicating greater maternal attachment. The mean score of mother attachment inventory (post-intervention assessment)
Growth Parameter
Time frame: end of week 4
The mean of baseline weight (in grams)
Growth Parameter
Time frame: end of week 8
The mean change in body weight from end of week 4 to end of week 8 (in grams)
Growth Parameter
Time frame: end of week 12
The mean change in body weight from end of week 8 to end of week 12 (in grams)
Growth Parameter
Time frame: end of week 16
The mean change in body weight from end of week 12 to week end of 16 (in grams)
Growth Parameter
Time frame: end of week 20
The mean change in body weight from end of week 16 to week end of 20 (in grams)
Growth Parameter
Time frame: end of week 4
The mean of baseline body length (in centimeters)
Growth Parameter
Time frame: end of week 8
The mean change in body length from end of week 4 to end of week 8 (in centimeters)
Growth Parameter
Time frame: end of week 12
The mean change in body length from end of week 8 to end of week 12 (in centimeters)
Growth Parameter
Time frame: end of week 16
The mean change in body length from end of week 12 to end of week 16 (in centimeters)
Growth Parameter
Time frame: end of week 20
The mean change in body length from end of week 16 to end of week 20 (in centimeters)
Head circumference
Time frame: end of week 4
The mean of baseline head circumference (in centimeters)
Head circumference
Time frame: end of week 8
The mean change in head circumference from end of week 4 to end of week 8 (in centimeters)
Head circumference
Time frame: end of week 12
The mean change in head circumference from end of week 8 to end of week 12 (in centimeters)
Head circumference
Time frame: end of week 16
The mean change in head circumference from end of week 12 to end of week 16 (in centimeters)
Head circumference
Time frame: end of week 20
The mean change in head circumference from end of week 16 to end of week 20 (in centimeters)
2 secondary outcomes
Pharis Self-Confidence
Time frame: end of week 4
Pharis Self-Confidence
Time frame: end of week 20
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 30 Jun 2022.
- Results publication: PubMed 28866286Vicente S, Verissimo M, Diniz E. Infant massage improves attitudes toward childbearing, maternal satisfaction and pleasure in parenting. Infant Behav Dev. 2017 Nov;49:114-119. doi: 10.1016/j.infbeh.2017.08.006. Epub 2017 Sep 1.
- Results publication: PubMed 25030689Gurol A, Polat S. The Effects of Baby Massage on Attachment between Mother and their Infants. Asian Nurs Res (Korean Soc Nurs Sci). 2012 Mar;6(1):35-41. doi: 10.1016/j.anr.2012.02.006. Epub 2012 Mar 10.
- Results publication: PubMed 32379694Lu LC, Lan SH, Hsieh YP, Lin LY, Chen JC, Lan SJ. Massage therapy for weight gain in preterm neonates: A systematic review and meta-analysis of randomized controlled trials. Complement Ther Clin Pract. 2020 May;39:101168. doi: 10.1016/j.ctcp.2020.101168. Epub 2020 Apr 1.
- Derived from this study: PubMed 37939520Ercelik ZE, Yilmaz HB. Effectiveness of infant massage on babies growth, mother-baby attachment and mothers' self-confidence: A randomized controlled trial. Infant Behav Dev. 2023 Nov;73:101897. doi: 10.1016/j.infbeh.2023.101897. Epub 2023 Nov 6.
- growth parametersLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Zübeyde Ezgi ERCELIK, MSc study chair
Bandırma Onyedi Eylül University
Hatice BAL YILMAZ, Proffessor principal investigator
Ege University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infant Massage in people with Growth and Attachment, run by Bandırma Onyedi Eylül 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 3 inclusion and 2 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 30 Jun 2022. 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?
Maternal Attachment Inventory (MAI) (time frame: end of week 4). The study lists 17 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 NCT05302427, which also lists 4 linked publications.
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 30 Jun 2022.