Bonding, Self-effıcacy and Vital Signs in Infants Undergoing Cardiovascular Surgery

NCT06158373 | Unknown

• 2 other identifiers: SCelikİlkay Güngör Satılmış
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Mother-Infant Interaction

Keywords

maternal; infant massage; safe swaddling; touching; congenital heart disease

Outcome Measures

Primary Outcomes (7)

• 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.

  "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.

  "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.

  "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.

  "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.

  "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.

  "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.

  "until discharge from intensive care" or "4 to 86 day"

Secondary Outcomes (3)

• Infant massage method and mother-infant attachment

  "until discharge from intensive care" or "4 to 86 day"

• Safe swaddling method and self-efficacy

  "until discharge from intensive care" or "4 to 86 day"

• Infant massage method and self-efficacy

  "until discharge from intensive care" or "4 to 86 day"

Other Outcomes (4)

• Infant massage method and sleep duration

  "until discharge from intensive care" or "30 minutes to 2 hour"

• Safe swaddling and hospitalization day

  "until discharge from intensive care" or "4 to 86 day"

• Infant massage method and hospitalization day

  "until discharge from intensive care" or "4 to 86 day"

Study Arms (3)

Infant Massage Group

EXPERIMENTAL

infant massage

Other: infant massage practice

Safe Swaddling Group

EXPERIMENTAL

safe swaddling

Other: Safe Swaddling

Control Group

SHAM COMPARATOR

control group

Other: Control

Interventions

infant massage practice OTHER

infant massage practice

Infant Massage Group

Safe Swaddling OTHER

Safe Swaddling

Safe Swaddling Group

Control OTHER

Control

Control Group

Eligibility Criteria

• Age: 3 Months - 120 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Sirin Celik

Maltepe, Istanbul, Turkey (Türkiye)

Location

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MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• İlkay Gungor Satilmis, Doc.Dr.

  İstanbul University-Cerrahpaşa

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Supervisor : Assoc. Prof. Dr.

Model Details: Randomized controlled experimental design with pretest posttest control group

Study Record Dates

• First Submitted: July 26, 2023
• First Posted: December 6, 2023
• Study Start: December 1, 2020
• Primary Completion: January 10, 2023
• Study Completion: March 1, 2024
• Last Updated: December 6, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)