NCT06320587

Brief Summary

This study was planned to determine the effect of kangaroo care applied by parents of premature newborns in the neonatal intensive care unit on the newborn's vital signs, perceived parenting self-efficacy level and attachment to the baby.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2024

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

February 12, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 20, 2024

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2024

Completed
Last Updated

March 20, 2024

Status Verified

February 1, 2024

Enrollment Period

2 months

First QC Date

February 12, 2024

Last Update Submit

March 19, 2024

Conditions

Keywords

kangaroo care

Outcome Measures

Primary Outcomes (8)

  • Mother-To-Infant Bonding Scale

    It will be applied to evaluate the mother's attachment level to her baby. The lowest score that can be obtained from the scale is 0 and the highest score is 24. The higher the score from the scale, the more it indicates a mother-infant attachment problem.

    It is designed to be applied from the first day after birth. It will be filled in before kangaroo care and after 5 weeks of kangaroo care.

  • Perceived Mother Parenting Self-Efficacy Scale

    It will be applied to measure mothers' perceived parenting self-efficacy. The scale consists of 3 sub-dimensions. These; care procedures, the belief in developing positive baby behaviors, the belief in recognizing the baby's behavior, and mother-baby interaction. The lowest score that can be obtained from the scale is 18 and the highest score is 72.As the score obtained increases, the degree of self-efficacy in mothers increases.

    It will be filled in before kangaroo care and after 5 weeks of kangaroo care.

  • Postnatal Paternal-Infant Attachment Questionnaire

    It will be applied to measure fathers' attachment levels to their babies. The lowest score that can be obtained from the scale is 18 and the highest score is 90.A high score from the scale indicates high bonding.

    It will be filled in before kangaroo care and after 5 weeks of kangaroo care.

  • Perceived Father Parenting Self-Efficacy Form

    It is aimed to determine the change in fathers' perceived parenting self-efficacy levels. The lowest score that can be obtained from the form is 0 and the highest score is 10. As the score increases, the degree of self effiacy in father increases.

    It will be filled in before kangaroo care and after 5 weeks of kangaroo care.

  • Physiological parameters of the premature infant: peak heart rate (BPM)

    It shows heart rate per minute of the infant. The normal peak heart rate should be between 100-160 BPM.

    Change from baseline at 5 weeks.

  • Physiological parameters of the premature infant: oxygen saturation (%)

    Oxygen saturation measures the percentage of oxyhemoglobin in the blood. The normal oxygen saturation should be between % 88 - % 100.

    Change from baseline at 5 weeks.

  • Physiological parameters of the premature infant: body temperature (°C)

    It shows body temperature of the infant. The normal body temperature of premature babies should be between 36,5 °C and 37,4 °C.

    Change from baseline at 5 weeks.

  • Physiological parameters of the premature infant:Respiration rate (RPM)

    It shows respiratory rate per minute of the infants. The normal respiratory rate of premature babies should be in the range of 40-60 RPM.

    Change from baseline at 5 weeks.

Study Arms (2)

Experimental group

EXPERIMENTAL

Newborns in this group will be given kangaroo care by both their mother and father.

Other: Kangaroo care practice by both mother and father

Control group

PLACEBO COMPARATOR

Newborns in this group will be given kangaroo care by only the mother.

Other: Kangaroo care practice only mother

Interventions

In this group, kangaroo care will be done by both mother and father. Mothers used the Mother-Infant Attachment Scale and the Perceived Maternal Parenting Self-Efficacy Scale as pretests; Fathers will also complete the Postpartum Father-Infant Attachment Survey and the Perceived Father Parenting Self-Efficacy Form. Mothers and fathers in the application group will be provided with kangaroo care for 45 minutes, 2 days a week for 5 weeks. The baby's vital signs will be monitored 30 minutes before each kangaroo care, at the 15th minute of each kangaroo care, and 30 minutes after the kangaroo care, and will be recorded on the Kangaroo Care Monitoring Form. After kangaroo care was completed at the end of 5 weeks, mothers used the Mother-Baby Attachment Scale and the Perceived Mother Parenting Self-Efficacy Scale as posttests; Postnatal Father-Infant Attachment Questionnaire and Perceived Father Parenting Self-Efficacy Form will be filled out by fathers.

Experimental group

In the control group, only the mother will care for the kangaroo. The application will be similar to the experimental group.

Control group

Eligibility Criteria

Age28 Weeks - 37 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Parents who volunteered to participate in the research
  • Parents who are Turkish citizens and speak Turkish
  • Preterm baby born between 28-37 weeks staying in the neonatal intensive care unit
  • The mother and father do not have any obstacles in taking care of the kangaroo.
  • Mothers and fathers who can come to the hospital regularly on the specified days will be included in the study.

You may not qualify if:

  • Not volunteering to participate in the research
  • Parent's inability to speak Turkish
  • Presence of a life-threatening major malformation or serious perinatal complication in the premature baby
  • Babies with umbilical catheters and central venous catheters will not be included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Etlik City Hospital

Ankara, 06170, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Gönül Kurt, Assoc.Prof

    Gülhane Sağlık Bilimleri University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gönül Kurt, Assoc.Prof

CONTACT

Meryem Büşra Borazan

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2024

First Posted

March 20, 2024

Study Start

February 1, 2024

Primary Completion

March 30, 2024

Study Completion

May 30, 2024

Last Updated

March 20, 2024

Record last verified: 2024-02

Locations