Effectiveness of Bonding-Based Education Intervention

NCT06186453 | Completed DMC

• 1 other identifier: Akdeniz Nursing Faculty
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

The study aimed to determine the impact of the Father-Preterm Newborn Bonding Programme (B-PreBAP) on fathers' parenting behaviours, stress levels, and support needs. Additionally, the study aimed to investigate the effect of B-PreBAP on the stress levels of preterm newborns.

Conditions

Preterm; Bonding

Keywords

Father; Bonding; Neonatal Intensive Care Unit

Outcome Measures

Primary Outcomes (1)

• Father Support Scale: Neonatal Intensive Care Unit

  It is a measurement tool to determine the support levels of fathers whose babies are hospitalised in the NICU. As the score on the scale increases, the support needs of fathers whose babies are hospitalized in the neonatal intensive care unit also increase. The total score of the scale is between 0-132 points.

  Data will be collected two times as pre-intervention and immediately post-intervention.

Secondary Outcomes (3)

• Neonatal Intensive Care Unit Parent Stress Scale

  Data will be collected two times as pre-intervention and immediately post-intervention.

• Postnatal Parental Behaviour Scale

  Data will be collected two times as pre-intervention and immediately post-intervention.

• Neonatal Stress Scale

  Data will be collected two times as pre-intervention and immediately post-intervention.

Study Arms (2)

Intervention group

EXPERIMENTAL

Father-Preterm Newborn Bonding Program

Behavioral: Father-Preterm Newborn Bonding Program

Control group

NO INTERVENTION

Routine nursing care will be applied

Interventions

Father-Preterm Newborn Bonding Program BEHAVIORAL

B-PreBAP will be applied to the fathers in the intervention group. B-PreBAP application will consist of two stages. The first stage will be passive participation and the second stage will be active participation. B-PreBAP will be applied to fathers for a total of two weeks (Heo \& Oh, 2019). In order to prevent interaction between the fathers in the intervention group and the fathers in the control group, the intervention will not be carried out during the routine visiting and information hours of the NICU (13:30-14:30 on Mondays, Wednesdays and Fridays). In the first two interviews, NICU introduction and B-PreBAP education about preterm newborns will be given. In the last three interviews, fathers will be involved in one-to-one practices with their preterm newborns.

Intervention group

Eligibility Criteria

• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Characteristics of the father; Turkish speaking Literate 18+ Open to communication and co-operation Fathers who agree to participate in the study will be included
• Characteristics of the preterm newborn Hospitalised in the NICU from the first postnatal day Preterm newborns born between 32 and 33 weeks

You may not qualify if:

• Characteristics of the father; Has a diagnosed psychiatric diagnosis Having twin preterm newborns
• Characteristics of the preterm newborn Intubated

Sponsors & Collaborators

• Akdeniz University: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Akdeniz University

Kepez, Antalya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 16, 2023
• First Posted: January 2, 2024
• Study Start: November 15, 2023
• Primary Completion: May 15, 2024
• Study Completion: July 17, 2024
• Last Updated: August 6, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)