The Effect of Kangaroo Care on Parents' Perceived Parenting Self-Efficacy, Infant Attachment and Newborn Vital Signs

Premature Infant Clinical Trial

Official title:

Determination of the Effect of Kangaroo Care Applied to Premature Newborns by Their Parents on the Newborn's Vital Signs, Parents' Perceived Parenting Self-Efficacy Level and Infant Attachment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06320587
• Other study ID #: AESH-EK1-2023-508
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: May 30, 2024

Study information

• Verified date: February 2024
• Source: Saglik Bilimleri Universitesi
• Contact: Gönül Kurt, Assoc.Prof
• Phone: 90(312)304
• Email: gonul.kurt[@]sbu.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The research is a randomized controlled trial and an experimental research design will be used. The research will be carried out with two groups as experimental (newborns given kangaroo care by both mother and father) and control (newborns given kangaroo care only by the mother) groups.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 30, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 28 Weeks to 37 Weeks

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Fathers
• Kangaroo Care
• Mother-Infant Interaction
• Premature Birth
• Premature Infant

Intervention

Other:
• Kangaroo care practice by both mother and father
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.
• Kangaroo care practice only mother
In the control group, only the mother will care for the kangaroo. The application will be similar to the experimental group.

Locations

Country	Name	City	State
Turkey	Ankara Etlik City Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Saglik Bilimleri Universitesi

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.