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NCT Number: NCT06195410

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

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.

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Key information

Conditions

Kangaroo Care

Age range

26 week–37 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Selcuk University, Konya, Selcuklu, Turkey (Türkiye)

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About this study

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. The order of mother and father application was determined randomly.

Data were collected using Physiological Parameters Form, Neonatal Comfort Behavior Scale, Parental Satisfaction Scale and Neonatal Intensive Care Unit Parental Stress Scale.

In the study, physiological parameters and Neonatal Comfort Behavior Scale scores of premature infants and Neonatal Intensive Care Unit Parental Stress Scale and Parental Satisfaction Scale scores of parents were evaluated. Pearson Chi-Square Test, Yates Correction and Fisher's Exact Test were used to compare categorical data according to groups. Two Independent Sample t Test was used to compare normally distributed variables and Mann Whitney U Test was used to compare non-normally distributed variables. Statistical significance level was accepted as p˂0.05.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. Physiological parameters of the premature infant:respiration rate

    Time frame: Change from baseline, 30min, and 65 min

    The infant's is respiratory rate per minute.

  2. Physiological parameters of the premature infant:peak heart rate

    Time frame: Change from baseline, 30min, and 65 min

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

  3. Physiological parameters of the premature infant: oxygen saturation

    Time frame: Change from baseline, 30min, and 65 min

    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.

  4. Physiological parameters of the premature infant: body temperature

    Time frame: Change from baseline, 30min, and 65 min

    Shows body temperature.

  5. Comfort Behavior scale scores of the premature infant

    Time frame: Change from baseline, 30min, and 65 min

    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.

  6. Parent Satisfaction points

    Time frame: baseline and 70 min

    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.

  7. Neonatal Intensive Care Unit Parental Stress Scale points

    Time frame: baseline and 70 min

    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.

Sponsors and collaborators

Lead sponsor

Selcuk University

Other

Registry information

Official study title

The Effect of Mother and Father Kangaroo Care on Newborn and Parent Outcomes in Premature Infants: A Randomized Cross Over Study

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 8, 2024
Registry last updated
Jan 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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