The Effect of Kangaroo Care After Cardiac Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-19

Study Completion Date

2024-05-20

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Infant ALL

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Control group (standard care)

The babies in this group will receive the standard care of the unit.

Group Type OTHER

Standard care

Intervention Type OTHER

The babies in this group will receive the standard care of the unit. The vital signs and pain scores of the babies will be recorded before the mother's visit for seven days. The vital signs and pain scores of the infants who received the standard care of the unit during one hour, which is the time of the mother's visit, will be recorded every 15 minutes for a total of 4 times. The vital signs and pain scores of the infant will be recorded in the first 15 minutes after the mother's visit.

Experimental group (Kangaroo care)

Kangaroo care will be applied to the experimental group for seven days.

Group Type EXPERIMENTAL

Kangaroo care

Intervention Type OTHER

Kangaroo care will be applied to the experimental group for seven days. Kangaroo care will be started for the babies in the intervention group when the baby is extubated, when the baby starts oral feeding and when the chest incision is closed. Consistent with previous research, mothers will provide skin-to-skin contact for at least 1 hour per day for seven days, starting immediately after feeding. The vital signs and pain scores of the babies will be recorded during the kangaroo care of the mother for seven days. During the kangaroo care, vital signs and pain scores of the infants will be recorded every 15 minutes for a total of 4 times. The vital signs and pain scores of the infant will be recorded in the first 15 minutes after the mother's visit.

Interventions

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Standard care

The babies in this group will receive the standard care of the unit. The vital signs and pain scores of the babies will be recorded before the mother's visit for seven days. The vital signs and pain scores of the infants who received the standard care of the unit during one hour, which is the time of the mother's visit, will be recorded every 15 minutes for a total of 4 times. The vital signs and pain scores of the infant will be recorded in the first 15 minutes after the mother's visit.

Intervention Type OTHER

Kangaroo care

Kangaroo care will be applied to the experimental group for seven days. Kangaroo care will be started for the babies in the intervention group when the baby is extubated, when the baby starts oral feeding and when the chest incision is closed. Consistent with previous research, mothers will provide skin-to-skin contact for at least 1 hour per day for seven days, starting immediately after feeding. The vital signs and pain scores of the babies will be recorded during the kangaroo care of the mother for seven days. During the kangaroo care, vital signs and pain scores of the infants will be recorded every 15 minutes for a total of 4 times. The vital signs and pain scores of the infant will be recorded in the first 15 minutes after the mother's visit.

Intervention Type OTHER

Eligibility Criteria

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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

Exclusion Criteria

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

Minimum Eligible Age

1 Day

Maximum Eligible Age

30 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dilara Cengizli, Nurse

Role: PRINCIPAL_INVESTIGATOR

Istanbul Health Sciences University Mehmet Akif Ersoy Chest Heart and Vascular Surgery Training and Research Hospital Paediatric Cardiovascular Surgery Intensive Care Unit