Effectiveness of Bonding-Based Education Intervention

Not Applicable

Completed

• Conditions: Bonding; Preterm
• Interventions: Behavioral: Father-Preterm Newborn Bonding Program

• Registration Number: NCT06186453
• Lead Sponsor: Akdeniz University

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.

Detailed Description

This study constitutes a part of the doctoral thesis titled "Development of Father-Preterm Newborn Bonding Model".

Study Timeline

• Study Start: 2023-11-15
• Study First Submitted: 2023-12-16
• Study First Submitted QC: 2023-12-16
• Study First Posted: 2024-01-02
• Primary Completion: 2024-05-15
• Study Completion: 2024-07-17
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-03
• Last Update Posted: 2024-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 66

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Father-Preterm Newborn Bonding Program	Father-Preterm Newborn Bonding Program

Primary Outcome Measures

Name	Time	Method
Father Support Scale: Neonatal Intensive Care Unit	Data will be collected two times as pre-intervention and immediately post-intervention.	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.

Secondary Outcome Measures

Name	Time	Method
Neonatal Intensive Care Unit Parent Stress Scale	Data will be collected two times as pre-intervention and immediately post-intervention.	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.
Postnatal Parental Behaviour Scale	Data will be collected two times as pre-intervention and immediately post-intervention.	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.
Neonatal Stress Scale	Data will be collected two times as pre-intervention and immediately post-intervention.	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.

Trial Locations

Locations (1)

Akdeniz University; 🇹🇷 Kepez, Antalya, Turkey