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The Effect of Kangaroo Father Care Transport on Preterm Infants

The Effect of Kangaroo Father Care Transport on Physiological Parameters, Anxiety and Paternal Attachment in Preterm Infants: A Randomized Controlled Study

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06725914
Enrollment
40
Registered
2024-12-10
Start date
2023-12-03
Completion date
2024-12-24
Last updated
2024-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fathers, Nurse's Role, Preterm Birth

Keywords

Father, Early kangaroo care, preterm infant, nurse, transport

Brief summary

This study was planned to investigate the effect of paternal kangaroo care and transport on physiologic parameters, anxiety and paternal attachment in preterm infants.

Detailed description

This study was conducted to determine the effects of paternal kangaroo care and transport of preterm infants on the physiologic parameters of the infant and the anxiety and attachment levels of the fathers.

Interventions

BEHAVIORALkangaroo care

Transport practice with paternal kangaroo care in preterm infants

Sponsors

Selcuk University
CollaboratorOTHER
Zeynep Büşra GÜÇLÜ
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Masking description

In this study, statistician blinding was used for the implementation of randomization and data analysis.

Intervention model description

The study was a single-blind, parallel group, randomized controlled experimental design.Randomization was performed by an independent investigator to avoid bias. Preterm infants were randomly assigned to the experimental and control groups (1:1) by simple randomization method. Using the permutation block randomization method, 6 permutations were formed as a block of 4 using the letters A and B. The number of samples was divided by the number of permutations (40/6=7) and sorted 7 times from 1 to 6 using a table of random numbers (www.randomizer.org). The combinations generated according to this order (e.g. BBAA (3) ABBA (2)) were prepared in sealed envelopes (40 pieces) by an independent statistician. Which letter represented which group was determined by lottery. To ensure confidentiality, each preterm infant was randomly assigned a numerical code and the results were reported to the researcher collectively in sealed opaque envelopes.

Eligibility

Sex/Gender
ALL
Age
34 Weeks to 37 Weeks
Healthy volunteers
Yes

Inclusion criteria

Neonatal related; * Born by caesarean section, * Born at 34-36+6 weeks gestation, * Apgar score of 7 and above at 1 and 5 minutes, * Stable and healthy, * Infants with a body weight of 1500 g and above were included. It's about the father; * Who volunteered to participate in the study, * No mental and psychological problems, * No communication problems (speech, hearing and severe visual impairment), * Fathers who did not carry contact-transmitted diseases (Covid-19, herpes simplex, scabies, etc.) were included.

Exclusion criteria

- Congenital anomalies, * Abdominal defects such as ompholocele, diaphragmatic hernia, gastroschisis, * Receiving invasive and noninvasive respiratory support, * With chest tube and umbilical catheter, * Foreign babies and their fathers were ostracized.

Design outcomes

Primary

MeasureTime frameDescription
Physiological Parameter Monitoring Form-Heart Rate3 minutes before the interventionHeart Rate in the Physiologic Parameter Monitoring Form was measured 3 minutes before (T0) the intervention.
Physiological Parameter Monitoring Form-SPO23 minutes before the interventionSPO2 in the Physiologic Parameter Monitoring Form was measured 3 minutes before (T0) the intervention.
Physiological Parameter Monitoring Form-Body temperature (°C)3 minutes before the interventionBody temperature (°C) in the Physiologic Parameter Monitoring Form was measured 3 minutes before (T0) the intervention.
Father-Infant Information Form-Paternal characteristics, maternal characteristics and infant characteristics15 minutes before the interventionPaternal characteristics (age, number of children, educational status, employment status, income status and kangaroo care experience), maternal characteristics (age, educational status, employment status, health problems during pregnancy) and infant characteristics (date of birth, gestational week, gender, birth weight, birth length, birth head circumference, APGAR score, type of anesthesia at birth) were recorded before the intervention.
State Anxiety Scale15 minutes before the interventionState Anxiety Scale was recorded 15 minutes before the intervention.
Father-Infant Attachment Scale15 minutes before the interventionFather-Infant Attachment Scale was recorded 15 minutes before the intervention.

Secondary

MeasureTime frameDescription
Physiological Parameter Monitoring Form-Heart Rate3 minutes after the end of kangaroo care (T2).Heart Rate in the Physiologic Parameter Monitoring Form was measured 3 minutes after (T2) the end of kangaroo care
Father-Infant Attachment Scale15 minutes after the intervention.Father-Infant Attachment Scale was recorded 15 minutes after the intervention.
Physiological Parameter Monitoring Form-SPO23 minutes after initiation of transport with kangaroo care.(T1)SPO2 in the Physiologic Parameter Monitoring Form was measured 3 minutes after (T1) initiation of transport with kangaroo care.
Fizyolojik Parametre İzleme Formu-SPO23 minutes after the end of kangaroo care (T2)SPO2 in the Physiologic Parameter Monitoring Form was measured 3 minutes after (T2) the end of kangaroo care
Physiological Parameter Monitoring Form-Body temperature (℃)3 minutes after initiation of transport with kangaroo care.(T1)Body temperature (℃) in the Physiologic Parameter Monitoring Form was measured 3 minutes after (T1) initiation of transport with kangaroo care.
Physiological Parameter Monitoring Form-Body temparature (℃)3 minutes after the end of kangaroo care (T2).Body temparature (℃) in the Physiologic Parameter Monitoring Form was measured 3 minutes after (T2) the end of kangaroo care
State Anxiety Scale15 minutes before the intervention (T2)State Anxiety Scale 15 minutes after the end of the intervention (T2)

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026