Effectiveness of Bonding-Based Education Intervention

Effectiveness of Bonding-Based Education Intervention for Fathers With Preterm Newborn Infants: Randomised Controlled Study

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.

Study Overview

• Status: Recruiting
• Conditions: Preterm; Bonding
• Intervention / Treatment: Behavioral: Father-Preterm Newborn Bonding Program

• Study Type: Interventional
• Enrollment (Estimated): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Antalya
    • Kepez, Antalya, Turkey
      • Recruiting
      • Akdeniz University
      • Contact: Uğur Gül; Phone Number: 2923 0(507) 528 59 90; Email: ugurgul6061@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. 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
2. Characteristics of the preterm newborn Hospitalised in the NICU from the first postnatal day Preterm newborns born between 32 and 33 weeks

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Father-Preterm Newborn Bonding Program	Behavioral: Father-Preterm Newborn Bonding Program; 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.
No Intervention: Control group; Routine nursing care will be applied

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neonatal Intensive Care Unit Parent Stress Scale	This scale measures the stress levels of parents in NICU. The lowest score is 0 and the highest score is 170. The fathers will be asked about the stress level of each variable in the scale and will be rated from 1 (not stressful) to 5 (extremely stressful). The higher the total score, the higher the stress level.	Data will be collected two times as pre-intervention and immediately post-intervention.
Postnatal Parental Behaviour Scale	This scale is an observational scale used to measure the behaviour of parents towards their newborn babies. As the total score increases, the interaction between the father and the infant increases. The total score of the scale is between 0-6 points. A higher total score on the scale indicates that the parent has more positive parenting behaviour towards his/her infant.	Data will be collected two times as pre-intervention and immediately post-intervention.
Neonatal Stress Scale	This scale was developed to measure the stress level of the newborn. As the total score increases, the stress level of the newborn increases. The total score of the scale is between 0-16 points.	Data will be collected two times as pre-intervention and immediately post-intervention.

Collaborators and Investigators

• Sponsor: Akdeniz University

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2023
• Primary Completion (Estimated): June 20, 2024
• Study Completion (Estimated): August 20, 2024

Study Registration Dates

• First Submitted: December 16, 2023
• First Submitted That Met QC Criteria: December 16, 2023
• First Posted (Actual): January 2, 2024

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 2, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Neonatal Intensive Care Unit; Father; Bonding
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Premature Birth
• Other Study ID Numbers: Akdeniz Nursing Faculty

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No