The Effect of Mother and Father Kangaroo Care on Newborn and Parent Outcomes in Premature Infants

NCT06195410 | Completed

• 1 other identifier: SelcukU-12c-2023
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 2

Brief Summary

First aim is to determine the effect of mother and father kangaroo care on the premature baby's Comfort Behavior level and physiological parameters (respiratory rate, heart rate, oxygen saturation and body temperature). Second aim is to determine the effect of mother and father kangaroo care on Parental Satisfaction and Neonatal Intensive Care Parental Stress level. The study was a a randomized crossover study with pretest-posttest design. It was carried out in the neonatal intensive care unit of Selçuk University Faculty of Medicine Hospital in Konya province. Study data were collected from 19 mother and 19 father and their premature newborns between February 2023 and August 2023.

Conditions

Kangaroo Care

Keywords

Mother Kangaroo Care; Father Kangaroo Care; Cross Over Study

Outcome Measures

Primary Outcomes (7)

• Physiological parameters of the premature infant:respiration rate

  The infant's is respiratory rate per minute.

  Change from baseline, 30min, and 65 min

• Physiological parameters of the premature infant:peak heart rate

  The infant's is heart rate per minute. Philips IntelliVue MP40 device was used to monitor heart rete.

  Change from baseline, 30min, and 65 min

• Physiological parameters of the premature infant: oxygen saturation

  Oxygen saturation measures the percentage of oxyhemoglobin (oxygen-bound hemoglobin) in the blood, and it is represented as arterial oxygen saturation (SaO2) and venous oxygen saturation (SvO2). Philips IntelliVue MP40 device was used to monitor %SpO2.

  Change from baseline, 30min, and 65 min

• Physiological parameters of the premature infant: body temperature

  Shows body temperature.

  Change from baseline, 30min, and 65 min

• Comfort Behavior scale scores of the premature infant

  Comfort Behavior scale was used. The Neonatal Comfort Behavior Scale (NEAS) is a Likert-type scale consisting of six parameters: alertness, calmness/agitation, respiratory response, crying, body movements, facial tension, and muscle tone. Each item in the scale is scored from 1 to 5. It is evaluated over the total score. The lowest score that can be obtained from the Newborn Comfort Behavior Scale (NEAS) is 6, and the highest score is 30.

  Change from baseline, 30min, and 65 min

• Parent Satisfaction points

  Parental Satisfaction scale was used. This scale was developed to assess parents' satisfaction in NICU. EMPATHIC-30 scale, 1= definitely not; 6 = absolutely yes and consists of five sub-dimensions; information (5 items), care and treatment (8 items), organization (5 items), parent involvement (6 items) and the professional attitude of the staff (6 items). One point represents the lowest satisfaction, while 6 points represents the highest satisfaction.

  baseline and 70 min

• Neonatal Intensive Care Unit Parental Stress Scale points

  Neonatal Intensive Care Unit Parental Stress Scale was used.The scale is a 34-item Likert-type scale with three subscales (Sights and Sounds, Infant Behavior and Appearance, and Parental Role Changes). Responses to the scale rate parents' stress level for each item from 1 (not at all stressful) to 5 (very stressful). As the scale score increases, stress increases.

  baseline and 70 min

Study Arms (2)

Comparator: Intervention Group

ACTIVE COMPARATOR

Other: kangaroo care application

Comparator

SHAM COMPARATOR

Other: kangaroo care application

Interventions

kangaroo care application OTHER

In the study, the mother applied kangaroo care to her premature baby for 65 minutes, and after a 24-72 hour washout period, the father applied kangaroo care for 65 minutes.

Comparator; Comparator: Intervention Group

Eligibility Criteria

• Age: 26 Weeks - 37 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• For premature infants;
• The baby is born before 36+6 weeks of gestation Stability of vital parameters at the time of application, Stable health status (cardiorespiratory stability, no congenital or chromosomal abnormalities, no history of intraventricular hemorrhage, no history of periventricular leukomalacia and NEC, no systemic and metabolic disorders),
• For parents;
• Willingness to participate in the research
• Being able to read and write Turkish

You may not qualify if:

• For premature infants;
• Being connected to a mechanical ventilator
• Congenital or chromosomal abnormality
• Being with deprivation syndrome
• Having a history of intraventricular hemorrhage
• For parents:
• Not being willing to care for kangaroos
• Having a physical disability to care for kangaroos

Sponsors & Collaborators

• Selcuk University: lead

Study Sites (2)

Selcuk University

Konya, Selcuklu, 42060, Turkey (Türkiye)

Location

Selcuk University

Konya, Turkey (Türkiye)

Location

Study Officials

• Busra Yahsi

  Selcuk University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 22, 2023
• First Posted: January 8, 2024
• Study Start: February 18, 2023
• Primary Completion: June 12, 2023
• Study Completion: August 18, 2023
• Last Updated: January 10, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)