The Effect of Kangaroo Care After Cardiac Surgery

Not Applicable

Recruiting

• Conditions: Infant ALL
• Interventions: Other: Kangaroo care; Other: Standard care

• Registration Number: NCT06400446
• Lead Sponsor: Istinye University

Brief Summary

The aim of this study was to investigate the effects of kangaroo care on the vital signs of infants undergoing cardiac surgery.

Hypothesis 1 (H1): Oxygen saturation levels of babies who are given kangaroo care are higher than babies who are not given kangaroo care.

Hypothesis 2 (H2): The peak heart rate of infants who receive kangaroo care is lower than infants who do not receive kangaroo care.

Hypothesis 3 (H3): The respiratory rate of infants who receive kangaroo care is lower than infants who do not receive kangaroo care.

Hypothesis 4 (H4): The arterial blood pressure of infants who receive kangaroo care is lower than infants who do not receive kangaroo care.

Hypothesis 5 (H5): The pain score of infants who received kangaroo care is lower than infants who did not receive kangaroo care.

Detailed Description

Kangaroo care has been found to be a feasible intervention before and after cardiac surgery to support infants with congenital heart disease, but it has been stated that formal standards and procedures need to be developed to transform kangaroo care into practice. Skin-to-skin contact is a low-cost, low-risk intervention that supports comfort and contributes to physiological stability in infants before and after neonatal cardiac surgery. It positively affects the pain level of infants. Clinical studies on the application of kangaroo mother care on infants undergoing cardiac surgery are limited in the literature.

Study Timeline

• Study Start: 2023-11-19
• Status Verified: 2024-04
• Study First Submitted: 2024-05-01
• Study First Submitted QC: 2024-05-01
• Last Update Submitted: 2024-05-01
• Study First Posted: 2024-05-06
• Last Update Posted: 2024-05-06
• Primary Completion: 2024-05-20
• Study Completion: 2024-05-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• The gestational week of the infant is greater than 37 weeks
• Cardiac surgery operation within the first 30 days of life
• The infant's chest incision is closed

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Exclusion Criteria

• The infant has non-cardiac congenital defects or syndrome
• Intubation of the infant

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group (Kangaroo care)	Kangaroo care	Kangaroo care will be applied to the experimental group for seven days.
Control group (standard care)	Standard care	The babies in this group will receive the standard care of the unit.

Primary Outcome Measures

Name	Time	Method
Change in oxygen saturation	Data will be collected immediately before care is given, at 15 minutes during care, and at 15 minutes after care is given. The change in these time intervals will be evaluated.	Oxygen saturation will be monitored.
Change in heart rate	Data will be collected immediately before care is given, at 15 minutes during care, and at 15 minutes after care is given. The change in these time intervals will be evaluated.	Heart rate will be monitored.
Change in respiratory rate	Data will be collected immediately before care is given, at 15 minutes during care, and at 15 minutes after care is given. The change in these time intervals will be evaluated.	Respiratory rate will be monitored.
Change in blood pressure	Data will be collected immediately before care is given, at 15 minutes during care, and at 15 minutes after care is given. The change in these time intervals will be evaluated.	Blood pressure will be monitored.
Change in level of pain	Data will be collected immediately before care is given, at 15 minutes during care, and at 15 minutes after care is given. The change in these time intervals will be evaluated.	The infants' pain level will be measured using the CRIES(Crying, Requires O2, Increased vital signs,Expression, Sleepless). The scale is used in the evaluation of postoperative pain in premature babies (between 32-36 weeks of gestation) and postoperative pain. Starting from the thirty-second gestational week, it is preferred in neonates and children between 6 months, especially in intensive care units.The Scale was developed by Krechel \& Bildner, 1995. Crying status, oxygen saturation, heart rate and/or blood pressure, facial expression and sleep status are the parameters used in the evaluation. Each parameter is scored out of two; a score of 3-4 indicates mild to moderate pain; values of five and above indicate severe pain.

Trial Locations

Locations (1)

Selvinaz Albayrak; 🇹🇷 Istanbul, Zeytinburnu, Turkey