Effectiveness of Bonding-Based Education Intervention

August 3, 2024 updated by: Uğur Gül, Akdeniz University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
66

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Antalya
      • Kepez, Antalya, Turkey
        • Akdeniz University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Father Support Scale: Neonatal Intensive Care Unit
Time Frame: 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.
Data will be collected two times as pre-intervention and immediately post-intervention.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Neonatal Intensive Care Unit Parent Stress Scale
Time Frame: 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.
Data will be collected two times as pre-intervention and immediately post-intervention.
Postnatal Parental Behaviour Scale
Time Frame: 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.
Data will be collected two times as pre-intervention and immediately post-intervention.
Neonatal Stress Scale
Time Frame: 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.
Data will be collected two times as pre-intervention and immediately post-intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Akdeniz University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Tübitak

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 15, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 15, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 17, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 16, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 2, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 6, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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