Mother-Infant InteractionNCT06158373
Bonding, Self-effıcacy and Vital Signs in Infants Undergoing Cardiovascular Surgery
A study testing infant massage practice and Safe Swaddling in people with Mother-Infant Interaction, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
Congenital heart diseases, the most common type of congenital anomalies, which affect approximately 3% of all live births and are the second most common cause of death in infants, are associated with 7% of all neonatal deaths. Read more about this study
- Who is it for?
- Ages 3 months to 120 days
- Conditions the study is for
- Mother-Infant Interaction
- What is being tested?
- infant massage practice and Safe Swaddling
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2020to 1 Mar 2024
- 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 3 months to 120 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Born term,
- Those who have undergone CVS surgery and sternatomy
- Pediatric CVD intensive care unit patients
- Extubated
- Watched accompanied by his mother
- Can be breastfed by his mother
Show all 11Show fewer
- Can be fed enterally
- No arrhythmia
- Clotting factors are within normal limits
- Baby and mother with 'Not at Risk' or PCR result 'Negative'
- Babies whose mothers accept the training and practice within the scope of the research.
Who cannot join
- Those with 'Risky' or PCR result 'Positive' baby and mother during follow-up
- Sudden weight loss or acute gastrointestinal system problems
- Babies who are at risk of bleeding and cannot feed (with chylothorax etc.)
- Extubated babies with risk of reintubation and respiratory distress
- Babies whose mothers leave them for various reasons.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Mother's Massage and Safe Swaddling on Bonding, Self-effıcacy and Vital Signs in Infants Undergoing Cardiovascular Surgery
Congenital heart diseases, the most common type of congenital anomalies, which affect approximately 3% of all live births and are the second most common cause of death in infants, are associated with 7% of all neonatal deaths. Among the interventions that can be applied with family-centered care of newborns followed in the intensive care unit, infant massage and safe wrapping are suggested interventions for mother-infant bonding and parental self-efficacy through the infant's sense of touch.
Objective: The aim of this study was to increase mother-infant attachment, increase the self-efficacy of the mother by taking an active role in baby care, reduce the baby's pain and stabilize vital signs, and increase the adaptation of the baby and the mother to the process and reduce the hospitalization day.
Read more
In this study, it was aimed to evaluate the effects of maternal massage and safe swaddling on attachment, self-efficacy, and vital signs of the infant in infants undergoing cardiovascular surgery (CVC).
The sample of the study, which was conducted in an experimental design with a pre-test-post-test control group, consisted of 36 infants and their mothers who had CVC between December 2020 and January 2022 and were hospitalized in the intensive care unit. Infant massage (n:12), safe swaddling (n:12) and control group (n:12) mothers were determined by computerized randomization. After the mother-infant pre-assessment questionnaire, Parental Self-Efficacy Scale (PSES) Scale, and Maternal Attachment Inventory (MAI) pre-tests were applied to the mothers, infant massage and safe swaddling instruction were given to the mothers. The hemodynamic findings of the infant were recorded before, during and after the practices. Post-tests were applied before hospital discharge.
Read the detailed description
Of the 130 million children born in the world each year, four million die in the neonatal stage. Congenital heart disease (CHD) is a serious congenital anomaly that can be seen at a rate of 5-8 per 1000 live births and is associated with 7% of all neonatal deaths (Aykan et al., 2022; Ertürk, 2016). Although pediatric cardiology and pediatric cardiovascular surgery have advanced, current data show that 21% of infants with congenital heart disease still die in the first month and 40% die due to congenital malformations (Beider et al., 2010). Early diagnosis of CHD, which is difficult to diagnose due to hemodynamic difference, and planning the treatment are important in terms of reducing morbidity and mortality in children (Bulut et al., 2012). While most of the babies with severe heart disease die in the first weeks of their lives, 25% of them need surgical intervention in the first week of their life (Özkan et al., 2010).
Preterm and term newborns, who have to spend the first week of their lives in neonatal intensive care units, are exposed to many invasive procedures (2-3 or 8-10 times a day) and experience pain and stress for different reasons. The pain experienced by the baby can prevent his behavior, family-baby interaction, and the baby's adaptation to the outside world, as well as cause changes in the development of the brain and senses, and growth is negatively affected (Derebent, 2006). By maintaining the balance between medical interventions and good primary care, babies' stress, pain and anxiety symptoms should be reduced. Easy-to-apply, low-cost non-pharmacological methods can be effective alone in pain caused by small invasive interventions; It has been reported that when used together with pharmacological methods, they increase the effectiveness of drugs (Şaduman, 2011).
The mother, whose baby is in the intensive care unit, has difficulties in establishing a close relationship with her child, and the mother's anxiety makes the attachment process more difficult. Effective nursing interventions to meet the needs of parents; helping parents to understand the infant's reactions, expressing their fears and expectations, actively listening to them, answering questions honestly, informing the parent about the treatment plan and program. It is also a nurse's responsibility to ensure mother-child interaction by enabling the mother to participate more in the care of the child (Özyazıcıoğlu, 2009). Increasing maternal experiences is important in mother-infant interaction. The most important component of these interventions is that intensive care nurses help the mother to be a good observer in evaluating her behavior in order to increase the mother's self-confidence in taking care of the baby and to strengthen her better relationship with her baby. The goal is primarily to ensure that the mother perceives her baby positively. Then, it is to give the mother the opportunity to touch, hold, care and observe her baby and to support her to give sensitive and positive reactions to her reactions to environmental stimuli. Thus, the mother's self-confidence, her ability to read the baby's reactions and her ability to meet the baby's needs are increased (Aras et al., 2013). The most commonly used non-pharmacological techniques in the care of these babies are various techniques and therapies such as reducing environmental stimuli, individualized developmental care and evaluation program of the newborn, music therapy, breastfeeding, supporting non-nutritive sucking, giving sweet solution, skin-to-skin contact, changing position, hugging, kangaroo care, massage therapy and wrapping. These techniques and therapies have an improving effect on cardiovascular and skeletal muscle functions (Beider et al., 2010; Yıldız, 2017).
The sense of touch is very important in the child's perception of his environment, especially in the newborn and infancy period. The baby communicates and recognizes his environment through the sense of touch. Appropriate stimulation of the sense of touch supports psychosocial development. Baby massage is a simple, inexpensive and effective technique that is beneficial for baby development. Baby massage is a new practice in our country, which many families are interested in, both for this reason and because it allows parents to freely apply it to their babies. Touch is proof of love. The creation of mother-father-infant interaction and the development of healthy attachment affect the development of the baby and his whole life. The family's loving attachment to the baby is the most important factor that accelerates its healthy growth and development. Massage; It is the mechanical and nervous stimulation of the skin, subcutaneous adipose tissue, muscles, internal organs, metabolism, circulation and lymph system for therapeutic and/or protective purposes. Many positive effects such as providing relaxation, reducing painful muscle tensions, relieving sleep problems and pain, improving self-esteem in individuals with physical disorders and terminal illness, and managing mental health problems can be achieved with massage application (Gürol, 2010). In addition, baby massage is between mother and baby.
- Conditions
- Mother-Infant Interaction
- Being tested
- infant massage practice, Safe Swaddling, Control
- Keywords
- maternal, infant massage, safe swaddling, touching, congenital heart disease
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
infant massage practiceOther
infant massage practice
Safe SwaddlingOther
Safe Swaddling
ControlOther
Control
| Study group | Role | What they receive |
|---|---|---|
| Infant Massage Group | Experimental | infant massage Receives: Other: infant massage practice |
| Safe Swaddling Group | Experimental | safe swaddling Receives: Other: Safe Swaddling |
| Control Group | Sham comparator | control group Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safe swaddling method and Pain Score
The pain score of infants who have undergone cardiovascular surgery and whose mothers apply safe swaddling method is lower than the control group.
Measured: "until discharge from intensive care" or "4 to 86 day"
Infant massage method and Pain Score
Infants who have undergone cardiovascular surgery who are given infant massage by their mothers have lower pain scores than the control group.
Measured: "until discharge from intensive care" or "4 to 86 day"
Safe swaddling method and body temperature
Body temperature is infants who have undergone cardiovascular surgery and whose mothers applied safe swaddling are more stable compared to the control group.
Measured: "until discharge from intensive care" or "between 36,6-37,5 degrees"
Safe swaddling method and body temperature
Body temperature is infants who have undergone cardiovascular surgery and whose mothers applied safe swaddling are more stable compared to the control group.
Measured: "until discharge from intensive care" and "between 36,6-37,5 degrees"
Safe swaddling method and respiratory rate
Respiratory rate is infants who have undergone cardiovascular surgery and whose mothers applied safe swaddling are more stable compared to the control group.
Measured: "until discharge from intensive care" and " between 30-60 times per minute"
Infant massage method and respiratory rate
Respiratory rate is infants who have undergone cardiovascular surgery who are given infant massage by their mothers are more stable compared to the control group.
Measured: "until discharge from intensive care" and " between 30-60 times per minute"
Safe swaddling method and mother-infant attachment
The mother-infant attachment of mothers who apply safe swaddling method to their infants who have undergone cardiovascular surgery is higher than the control group.
Measured: "until discharge from intensive care" or "4 to 86 day"
Secondary outcomes (3)
Infant massage method and mother-infant attachment
Mothers who apply infant massage to their infants who have undergone cardiovascular surgery have higher mother-infant attachment than the control group.
Measured: "until discharge from intensive care" or "4 to 86 day"
Safe swaddling method and self-efficacy
The self-efficacy of mothers who apply safe swaddling method to their infants who have undergone cardiovascular surgery is higher than the control group.
Measured: "until discharge from intensive care" or "4 to 86 day"
Infant massage method and self-efficacy
The self-efficacy of mothers who apply infant massage to their infants who have undergone cardiovascular surgery is higher than the control group.
Measured: "until discharge from intensive care" or "4 to 86 day"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start1 Dec 2020
- Primary completion10 Jan 2023
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (39)Papers the sponsor has linked to this study.
- Other trials for Mother-Infant InteractionStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled experimental design with pretest posttest control group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sirin Celik, Istanbul University - Cerrahpasa
- Investigators
- İlkay Gungor Satilmis, Doc.Dr., Study director, İstanbul University-Cerrahpaşa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06158373
- Sponsor's protocol ID
- SCelik
- Other IDs
- İlkay Güngör Satılmış
- Status last verified
- Nov 2023
- First submitted
- 26 Jul 2023
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Afand N, Keshavarz M, Fatemi NS, Montazeri A. Effects of infant massage on state anxiety in mothers of preterm infants prior to hospital discharge. J Clin Nurs. 2017 Jul;26(13-14):1887-1892. doi: 10.1111/jocn.13498. Epub 2017 Mar 24.
PubMed 27486850Beider S, Boulanger KT, Joshi M, Pan YP, Chang RK. Measuring the effects of massage on exercise performance and cardiopulmonary response in children with and without heart disease: a pilot study. Int J Ther Massage Bodywork. 2010 Sep 28;3(3):12-6. doi: 10.3822/ijtmb.v3i3.86.
PubMed 21589710Field T, Gonzalez G, Diego M, Mindell J. Mothers massaging their newborns with lotion versus no lotion enhances mothers' and newborns' sleep. Infant Behav Dev. 2016 Nov;45(Pt A):31-37. doi: 10.1016/j.infbeh.2016.08.004. Epub 2016 Sep 3.
PubMed 27599170Vicente 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 28866286Ferentzi H, Rippe RCA, Latour JM, Schubert S, Girch A, Jonebratt Stocker M, Pfitzer C, Photiadis J, Sandica E, Berger F, Schmitt KRL. Family-Centered Care at Pediatric Cardiac Intensive Care Units in Germany and the Relationship With Parent and Infant Well-Being: A Study Protocol. Front Pediatr. 2021 Aug 12;9:666904. doi: 10.3389/fped.2021.666904. eCollection 2021.
PubMed 34458208Re JM, Dean S, Mullaert J, Guedeney A, Menahem S. Maternal Distress and Infant Social Withdrawal (ADBB) Following Infant Cardiac Surgery for Congenital Heart Disease. World J Pediatr Congenit Heart Surg. 2018 Nov;9(6):624-637. doi: 10.1177/2150135118788788.
PubMed 30322360Kasparian NA, Kan JM, Sood E, Wray J, Pincus HA, Newburger JW. Mental health care for parents of babies with congenital heart disease during intensive care unit admission: Systematic review and statement of best practice. Early Hum Dev. 2019 Dec;139:104837. doi: 10.1016/j.earlhumdev.2019.104837. Epub 2019 Aug 24.
PubMed 31455569Gaskin K, Kennedy F. Care of infants, children and adults with congenital heart disease. Nurs Stand. 2019 Jul 26;34(8):37-42. doi: 10.7748/ns.2019.e11405.
PubMed 31468777Bowlby J. Attachment and loss: retrospect and prospect. Am J Orthopsychiatry. 1982 Oct;52(4):664-678. doi: 10.1111/j.1939-0025.1982.tb01456.x. No abstract available.
PubMed 7148988Wittkowski A, Garrett C, Calam R, Weisberg D. Self-Report Measures of Parental Self-Efficacy: A Systematic Review of the Current Literature. J Child Fam Stud. 2017;26(11):2960-2978. doi: 10.1007/s10826-017-0830-5. Epub 2017 Jul 6.
PubMed 29081640Pados BF, McGlothen-Bell K. Benefits of Infant Massage for Infants and Parents in the NICU. Nurs Womens Health. 2019 Jun;23(3):265-271. doi: 10.1016/j.nwh.2019.03.004. Epub 2019 May 3.
PubMed 31059673Serrano MS, Doren FM, Wilson L. Teaching Chilean mothers to massage their full-term infants: effects on maternal breast-feeding and infant weight gain at age 2 and 4 months. J Perinat Neonatal Nurs. 2010 Apr-Jun;24(2):172-81. doi: 10.1097/JPN.0b013e3181db5377.
PubMed 20442614Field T. Massage therapy research review. Complement Ther Clin Pract. 2014 Nov;20(4):224-9. doi: 10.1016/j.ctcp.2014.07.002. Epub 2014 Aug 1.
PubMed 25172313Pease AS, Fleming PJ, Hauck FR, Moon RY, Horne RS, L'Hoir MP, Ponsonby AL, Blair PS. Swaddling and the Risk of Sudden Infant Death Syndrome: A Meta-analysis. Pediatrics. 2016 Jun;137(6):e20153275. doi: 10.1542/peds.2015-3275. Epub 2016 May 9.
PubMed 27244847Barry ES. Co-sleeping as a proximal context for infant development: The importance of physical touch. Infant Behav Dev. 2019 Nov;57:101385. doi: 10.1016/j.infbeh.2019.101385. Epub 2019 Oct 23.
PubMed 31655427
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mother's Massage and Safe Swaddling on Bonding, Self-effıcacy and Vital Signs in Infants Undergoing Cardiovascular Surgery
- ClinicalTrials.gov ID
- NCT06158373
- Acronym / sponsor ID
- SCelik
- Conditions
- Mother-Infant Interaction
- Keywords
- maternal, infant massage, safe swaddling, touching, congenital heart disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 10 Jan 2023 (actual)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 6 Dec 2023 (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.
Congenital heart diseases, the most common type of congenital anomalies, which affect approximately 3% of all live births and are the second most common cause of death in infants, are associated with 7% of all neonatal deaths. Among the interventions that can be applied with family-centered care of newborns followed in the intensive care unit, infant massage and safe wrapping are suggested interventions for mother-infant bonding and parental self-efficacy through the infant's sense of touch.
Objective: The aim of this study was to increase mother-infant attachment, increase the self-efficacy of the mother by taking an active role in baby care, reduce the baby's pain and stabilize vital signs, and increase the adaptation of the baby and the mother to the process and reduce the hospitalization day.
In this study, it was aimed to evaluate the effects of maternal massage and safe swaddling on attachment, self-efficacy, and vital signs of the infant in infants undergoing cardiovascular surgery (CVC).
The sample of the study, which was conducted in an experimental design with a pre-test-post-test control group, consisted of 36 infants and their mothers who had CVC between December 2020 and January 2022 and were hospitalized in the intensive care unit. Infant massage (n:12), safe swaddling (n:12) and control group (n:12) mothers were determined by computerized randomization. After the mother-infant pre-assessment questionnaire, Parental Self-Efficacy Scale (PSES) Scale, and Maternal Attachment Inventory (MAI) pre-tests were applied to the mothers, infant massage and safe swaddling instruction were given to the mothers. The hemodynamic findings of the infant were recorded before, during and after the practices. Post-tests were applied before hospital discharge.
Detailed description
Of the 130 million children born in the world each year, four million die in the neonatal stage. Congenital heart disease (CHD) is a serious congenital anomaly that can be seen at a rate of 5-8 per 1000 live births and is associated with 7% of all neonatal deaths (Aykan et al., 2022; Ertürk, 2016). Although pediatric cardiology and pediatric cardiovascular surgery have advanced, current data show that 21% of infants with congenital heart disease still die in the first month and 40% die due to congenital malformations (Beider et al., 2010). Early diagnosis of CHD, which is difficult to diagnose due to hemodynamic difference, and planning the treatment are important in terms of reducing morbidity and mortality in children (Bulut et al., 2012). While most of the babies with severe heart disease die in the first weeks of their lives, 25% of them need surgical intervention in the first week of their life (Özkan et al., 2010).
Preterm and term newborns, who have to spend the first week of their lives in neonatal intensive care units, are exposed to many invasive procedures (2-3 or 8-10 times a day) and experience pain and stress for different reasons. The pain experienced by the baby can prevent his behavior, family-baby interaction, and the baby's adaptation to the outside world, as well as cause changes in the development of the brain and senses, and growth is negatively affected (Derebent, 2006). By maintaining the balance between medical interventions and good primary care, babies' stress, pain and anxiety symptoms should be reduced. Easy-to-apply, low-cost non-pharmacological methods can be effective alone in pain caused by small invasive interventions; It has been reported that when used together with pharmacological methods, they increase the effectiveness of drugs (Şaduman, 2011).
The mother, whose baby is in the intensive care unit, has difficulties in establishing a close relationship with her child, and the mother's anxiety makes the attachment process more difficult. Effective nursing interventions to meet the needs of parents; helping parents to understand the infant's reactions, expressing their fears and expectations, actively listening to them, answering questions honestly, informing the parent about the treatment plan and program. It is also a nurse's responsibility to ensure mother-child interaction by enabling the mother to participate more in the care of the child (Özyazıcıoğlu, 2009). Increasing maternal experiences is important in mother-infant interaction. The most important component of these interventions is that intensive care nurses help the mother to be a good observer in evaluating her behavior in order to increase the mother's self-confidence in taking care of the baby and to strengthen her better relationship with her baby. The goal is primarily to ensure that the mother perceives her baby positively. Then, it is to give the mother the opportunity to touch, hold, care and observe her baby and to support her to give sensitive and positive reactions to her reactions to environmental stimuli. Thus, the mother's self-confidence, her ability to read the baby's reactions and her ability to meet the baby's needs are increased (Aras et al., 2013). The most commonly used non-pharmacological techniques in the care of these babies are various techniques and therapies such as reducing environmental stimuli, individualized developmental care and evaluation program of the newborn, music therapy, breastfeeding, supporting non-nutritive sucking, giving sweet solution, skin-to-skin contact, changing position, hugging, kangaroo care, massage therapy and wrapping. These techniques and therapies have an improving effect on cardiovascular and skeletal muscle functions (Beider et al., 2010; Yıldız, 2017).
The sense of touch is very important in the child's perception of his environment, especially in the newborn and infancy period. The baby communicates and recognizes his environment through the sense of touch. Appropriate stimulation of the sense of touch supports psychosocial development. Baby massage is a simple, inexpensive and effective technique that is beneficial for baby development. Baby massage is a new practice in our country, which many families are interested in, both for this reason and because it allows parents to freely apply it to their babies. Touch is proof of love. The creation of mother-father-infant interaction and the development of healthy attachment affect the development of the baby and his whole life. The family's loving attachment to the baby is the most important factor that accelerates its healthy growth and development. Massage; It is the mechanical and nervous stimulation of the skin, subcutaneous adipose tissue, muscles, internal organs, metabolism, circulation and lymph system for therapeutic and/or protective purposes. Many positive effects such as providing relaxation, reducing painful muscle tensions, relieving sleep problems and pain, improving self-esteem in individuals with physical disorders and terminal illness, and managing mental health problems can be achieved with massage application (Gürol, 2010). In addition, baby massage is between mother and baby.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomized controlled experimental design with pretest posttest control group
| Arm | Type | Receives |
|---|---|---|
| Infant Massage Group | Experimental | Other: infant massage practiceinfant massage |
| Safe Swaddling Group | Experimental | Other: Safe Swaddlingsafe swaddling |
| Control Group | Sham comparator | Other: Controlcontrol group |
Who may qualify
- Ages
- 3 months to 120 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- Born term,
- Those who have undergone CVS surgery and sternatomy
- Pediatric CVD intensive care unit patients
- Extubated
- Watched accompanied by his mother
Key exclusion criteria (5 listed)
- Those with 'Risky' or PCR result 'Positive' baby and mother during follow-up
- Sudden weight loss or acute gastrointestinal system problems
- Babies who are at risk of bleeding and cannot feed (with chylothorax etc.)
- Extubated babies with risk of reintubation and respiratory distress
- Babies whose mothers leave them for various reasons.
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 massage practiceinfant massage practice | Other | Infant Massage Group |
| Safe SwaddlingSafe Swaddling | Other | Safe Swaddling Group |
| ControlControl | Other | Control Group |
Primary outcome
Safe swaddling method and Pain Score
Time frame: "until discharge from intensive care" or "4 to 86 day"
The pain score of infants who have undergone cardiovascular surgery and whose mothers apply safe swaddling method is lower than the control group.
Infant massage method and Pain Score
Time frame: "until discharge from intensive care" or "4 to 86 day"
Infants who have undergone cardiovascular surgery who are given infant massage by their mothers have lower pain scores than the control group.
Safe swaddling method and body temperature
Time frame: "until discharge from intensive care" or "between 36,6-37,5 degrees"
Body temperature is infants who have undergone cardiovascular surgery and whose mothers applied safe swaddling are more stable compared to the control group.
Safe swaddling method and body temperature
Time frame: "until discharge from intensive care" and "between 36,6-37,5 degrees"
Body temperature is infants who have undergone cardiovascular surgery and whose mothers applied safe swaddling are more stable compared to the control group.
Safe swaddling method and respiratory rate
Time frame: "until discharge from intensive care" and " between 30-60 times per minute"
Respiratory rate is infants who have undergone cardiovascular surgery and whose mothers applied safe swaddling are more stable compared to the control group.
Infant massage method and respiratory rate
Time frame: "until discharge from intensive care" and " between 30-60 times per minute"
Respiratory rate is infants who have undergone cardiovascular surgery who are given infant massage by their mothers are more stable compared to the control group.
Safe swaddling method and mother-infant attachment
Time frame: "until discharge from intensive care" or "4 to 86 day"
The mother-infant attachment of mothers who apply safe swaddling method to their infants who have undergone cardiovascular surgery is higher than the control group.
3 secondary outcomes
Infant massage method and mother-infant attachment
Time frame: "until discharge from intensive care" or "4 to 86 day"
Safe swaddling method and self-efficacy
Time frame: "until discharge from intensive care" or "4 to 86 day"
Infant massage method and self-efficacy
Time frame: "until discharge from intensive care" or "4 to 86 day"
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
- Background: PubMed 27486850Afand N, Keshavarz M, Fatemi NS, Montazeri A. Effects of infant massage on state anxiety in mothers of preterm infants prior to hospital discharge. J Clin Nurs. 2017 Jul;26(13-14):1887-1892. doi: 10.1111/jocn.13498. Epub 2017 Mar 24.
- Background: PubMed 21589710Beider S, Boulanger KT, Joshi M, Pan YP, Chang RK. Measuring the effects of massage on exercise performance and cardiopulmonary response in children with and without heart disease: a pilot study. Int J Ther Massage Bodywork. 2010 Sep 28;3(3):12-6. doi: 10.3822/ijtmb.v3i3.86.
- Background: PubMed 27599170Field T, Gonzalez G, Diego M, Mindell J. Mothers massaging their newborns with lotion versus no lotion enhances mothers' and newborns' sleep. Infant Behav Dev. 2016 Nov;45(Pt A):31-37. doi: 10.1016/j.infbeh.2016.08.004. Epub 2016 Sep 3.
- Background: 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.
- Background: PubMed 34458208Ferentzi H, Rippe RCA, Latour JM, Schubert S, Girch A, Jonebratt Stocker M, Pfitzer C, Photiadis J, Sandica E, Berger F, Schmitt KRL. Family-Centered Care at Pediatric Cardiac Intensive Care Units in Germany and the Relationship With Parent and Infant Well-Being: A Study Protocol. Front Pediatr. 2021 Aug 12;9:666904. doi: 10.3389/fped.2021.666904. eCollection 2021.
- Background: PubMed 30322360Re JM, Dean S, Mullaert J, Guedeney A, Menahem S. Maternal Distress and Infant Social Withdrawal (ADBB) Following Infant Cardiac Surgery for Congenital Heart Disease. World J Pediatr Congenit Heart Surg. 2018 Nov;9(6):624-637. doi: 10.1177/2150135118788788.
- Background: PubMed 31455569Kasparian NA, Kan JM, Sood E, Wray J, Pincus HA, Newburger JW. Mental health care for parents of babies with congenital heart disease during intensive care unit admission: Systematic review and statement of best practice. Early Hum Dev. 2019 Dec;139:104837. doi: 10.1016/j.earlhumdev.2019.104837. Epub 2019 Aug 24.
- Background: PubMed 31468777Gaskin K, Kennedy F. Care of infants, children and adults with congenital heart disease. Nurs Stand. 2019 Jul 26;34(8):37-42. doi: 10.7748/ns.2019.e11405.
- Background: PubMed 7148988Bowlby J. Attachment and loss: retrospect and prospect. Am J Orthopsychiatry. 1982 Oct;52(4):664-678. doi: 10.1111/j.1939-0025.1982.tb01456.x. No abstract available.
- Background: PubMed 29081640Wittkowski A, Garrett C, Calam R, Weisberg D. Self-Report Measures of Parental Self-Efficacy: A Systematic Review of the Current Literature. J Child Fam Stud. 2017;26(11):2960-2978. doi: 10.1007/s10826-017-0830-5. Epub 2017 Jul 6.
- Background: PubMed 31059673Pados BF, McGlothen-Bell K. Benefits of Infant Massage for Infants and Parents in the NICU. Nurs Womens Health. 2019 Jun;23(3):265-271. doi: 10.1016/j.nwh.2019.03.004. Epub 2019 May 3.
- Background: PubMed 20442614Serrano MS, Doren FM, Wilson L. Teaching Chilean mothers to massage their full-term infants: effects on maternal breast-feeding and infant weight gain at age 2 and 4 months. J Perinat Neonatal Nurs. 2010 Apr-Jun;24(2):172-81. doi: 10.1097/JPN.0b013e3181db5377.
- Individual participant dataSharing planned: No
Related trials for Mother-Infant Interaction
Recruiting
Nutritional Maturity in Preterm Newborns (Premature Infant Oral Motor Intervention, PIOMI)
Preterm, Preterm Infant Development
Active, not recruiting
Investigating Baby Behavior and Family Technology Use Study
Mobile Phone Use, Mother-Infant Interaction
Recruiting
Mother-infant Bonding in the Brain: a Mindfulness-based Intervention
Postpartum Depression, Postpartum Anxiety
Recruiting
The Effect of the Cesarean ERAS Protocol on Mother-Infant and Father-Infant Bonding: a Multicenter, Randomized Controlled Clinical Trial.
Bonding, ERAS
Recruiting
Continuous Delivery Room Skin-to-skin-study for Moderate and Late Preterm Infants
Preterm Birth, Mother-Infant Interaction
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.
İlkay Gungor Satilmis, Doc.Dr. study director
İstanbul University-Cerrahpaşa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing infant massage practice and Safe Swaddling in people with Mother-Infant Interaction, run by Istanbul University - Cerrahpasa 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 11 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: status not confirmed, as of the sponsor's last update on 6 Dec 2023. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
Safe swaddling method and Pain Score (time frame: "until discharge from intensive care" or "4 to 86 day"). The study lists 7 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 NCT06158373, which also lists 39 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 6 Dec 2023.