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Completed

NCT Number: NCT06186453

Effectiveness of Bonding-Based Education Intervention

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.

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Key information

Conditions

Preterm Bonding Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Akdeniz University

Kepez, Antalya, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Akdeniz University

Other

Collaborators

  • The Scientific and Technological Research Council of Turkey

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 2, 2024
Registry last updated
Aug 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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