The Effect of Kangaroo Care After Cardiac Surgery

NCT06400446 | Recruiting

• 1 other identifier: ISU-23-259
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Infant ALL

Keywords

Kangaroo care; Infant; Cardiac surgery; Vital signs

Outcome Measures

Primary Outcomes (5)

• Change in oxygen saturation

  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

  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

  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

  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

  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.

Study Arms (2)

Control group (standard care)

OTHER

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

Other: Standard care

Experimental group (Kangaroo care)

EXPERIMENTAL

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

Other: Kangaroo care

Interventions

Standard care 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.

Control group (standard care)

Kangaroo care 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.

Experimental group (Kangaroo care)

Eligibility Criteria

• Age: 1 Day - 30 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Istinye University: lead

Study Sites (1)

Selvinaz Albayrak

Istanbul, Zeytinburnu, 34360, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• Solaz-Garcia A, Lara-Canton I, Pinilla-Gonzalez A, Montejano-Lozoya R, Gimeno-Navarro A, Sanchez-Illana A, Marco-Pinol A, Vento M, Saenz-Gonzalez P. Impact of Kangaroo Care on Premature Infants' Oxygenation: Systematic Review. Neonatology. 2022;119(5):537-546. doi: 10.1159/000525014. Epub 2022 Jun 22.

  PMID: 35732143 RESULT

• Kelley-Quon LI, Kenney BD, Bartman T, Thomas R, Robinson V, Nwomeh BC, Bapat R. Safety and feasibility of skin-to-skin care for surgical infants: A quality improvement project. J Pediatr Surg. 2019 Nov;54(11):2428-2434. doi: 10.1016/j.jpedsurg.2019.02.016. Epub 2019 Feb 28.

  PMID: 30879741 RESULT

• Lisanti AJ, Vittner D, Medoff-Cooper B, Fogel J, Wernovsky G, Butler S. Individualized Family-Centered Developmental Care: An Essential Model to Address the Unique Needs of Infants With Congenital Heart Disease. J Cardiovasc Nurs. 2019 Jan/Feb;34(1):85-93. doi: 10.1097/JCN.0000000000000546.

  PMID: 30303895 RESULT

MeSH Terms

Interventions

Standard of Care; Kangaroo-Mother Care Method

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Patient Positioning; Patient Care; Therapeutics; Infant Care; Child Care; Health Services; Health Care Facilities Workforce and Services

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Selvinaz Albayrak, Asst Prof

CONTACT

+905438708905; selvinaz.albayrak@istinye.edu.tr

Selvinaz Albayrak, Asst Prof

CONTACT

+905438708905; selvinalbayrak@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2024
• First Posted: May 6, 2024
• Study Start: November 19, 2023
• Primary Completion: May 20, 2024
• Study Completion: May 20, 2024
• Last Updated: May 6, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)