The Effect of Kangaroo Care After Cardiac Surgery

May 1, 2024 updated by: Istinye University

The Effect of Kangaroo Care on Vital Signs of Infants After Cardiac Surgery

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control group (standard care)
The babies in this group will receive the standard care of the unit.
Other: 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.
Experimental: Experimental group (Kangaroo care)
Kangaroo care will be applied to the experimental group for seven days.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in oxygen saturation
Time Frame: 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.
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.
Change in heart rate
Time Frame: 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.
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.
Change in respiratory rate
Time Frame: 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.
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.
Change in blood pressure
Time Frame: 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.
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.
Change in level of pain
Time Frame: 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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istinye University

Investigators

  • Principal Investigator: Dilara Cengizli, Nurse, Istanbul Health Sciences University Mehmet Akif Ersoy Chest Heart and Vascular Surgery Training and Research Hospital Paediatric Cardiovascular Surgery Intensive Care Unit

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 19, 2023

Primary Completion (Estimated)

May 20, 2024

Study Completion (Estimated)

May 20, 2024

Study Registration Dates

First Submitted

May 1, 2024

First Submitted That Met QC Criteria

May 1, 2024

First Posted (Actual)

May 6, 2024

Study Record Updates

Last Update Posted (Actual)

May 6, 2024

Last Update Submitted That Met QC Criteria

May 1, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ISU-23-259

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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