Effectiveness of Bonding-Based Education Intervention

Preterm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06186453
• Other study ID #: Akdeniz Nursing Faculty
• Status: Recruiting
• Phase: N/A
• Start date: December 15, 2023
• Est. completion date: August 20, 2024

Study information

• Verified date: January 2024
• Source: Akdeniz University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: August 20, 2024
• Est. primary completion date: June 20, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Bonding
• Premature Birth
• Preterm

Intervention

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.

Locations

Country	Name	City	State
Turkey	Akdeniz University	Kepez	Antalya

Sponsors (1)

Lead Sponsor	Collaborator
Akdeniz University

Country where clinical trial is conducted

Turkey, 

Outcome

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