Clinical trial NCT06158373: Bonding, Self-effıcacy and Vital Signs in Infants Undergoing Cardiovascular Surgery
Official title: The Effect of Mother's Massage and Safe Swaddling on Bonding, Self-effıcacy and Vital Signs in Infants Undergoing Cardiovascular Surgery
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Mother-Infant Interaction
Keywords: maternal
infant massage
safe swaddling
touching
congenital heart disease
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2023-12-06
Enrollment: 36
Sex: ALL
Minimum age (years): 3
Maximum age (years): 120
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled experimental design with pretest posttest control group
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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
* 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.

Exclusion Criteria

* 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.

Primary outcomes:
measure: Safe swaddling method and Pain Score
timeFrame: "until discharge from intensive care" or "4 to 86 day"
measure: Infant massage method and Pain Score
timeFrame: "until discharge from intensive care" or "4 to 86 day"
measure: Safe swaddling method and body temperature
timeFrame: "until discharge from intensive care" or "between 36,6-37,5 degrees"
measure: Safe swaddling method and body temperature
timeFrame: "until discharge from intensive care" and "between 36,6-37,5 degrees"
measure: Safe swaddling method and respiratory rate
timeFrame: "until discharge from intensive care" and " between 30-60 times per minute"
measure: Infant massage method and respiratory rate
timeFrame: "until discharge from intensive care" and " between 30-60 times per minute"
measure: Safe swaddling method and mother-infant attachment
timeFrame: "until discharge from intensive care" or "4 to 86 day"
Secondary outcomes:
measure: Infant massage method and mother-infant attachment
timeFrame: "until discharge from intensive care" or "4 to 86 day"
measure: Safe swaddling method and self-efficacy
timeFrame: "until discharge from intensive care" or "4 to 86 day"
measure: Infant massage method and self-efficacy
timeFrame: "until discharge from intensive care" or "4 to 86 day"
Other outcomes:
measure: Infant massage method and sleep duration
timeFrame: "until discharge from intensive care" or "30 minutes to 2 hour"
measure: Safe swaddling and hospitalization day
timeFrame: "until discharge from intensive care" or "4 to 86 day"
measure: Infant massage method and hospitalization day
timeFrame: "until discharge from intensive care" or "4 to 86 day"
measure: Safe swaddling and Sleep duration
timeFrame: "until discharge from intensive care" or "30 minutes to 2 hour"
Locations:
city: Maltepe
country: Turkey
facility: Sirin Celik
state: İstanbul
Study officials:
affiliation: İstanbul University-Cerrahpaşa
name: İlkay Gungor Satilmis, Doc.Dr.
role: STUDY_DIRECTOR
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