PretermNCT06186453
Effectiveness of Bonding-Based Education Intervention
A study testing Father-Preterm Newborn Bonding Program in people with Preterm and Bonding, run by Akdeniz University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Any age, men onlyHealthy volunteers can take part
- What is being tested?
- Father-Preterm Newborn Bonding Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2023to 17 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Characteristics of the father; Has a diagnosed psychiatric diagnosis Having twin preterm newborns
- Characteristics of the preterm newborn Intubated
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
This study constitutes a part of the doctoral thesis titled "Development of Father-Preterm Newborn Bonding Model".
- Being tested
- Father-Preterm Newborn Bonding Program
- Keywords
- Father, Bonding, Neonatal Intensive Care Unit
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Father-Preterm Newborn Bonding ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Father-Preterm Newborn Bonding Program Receives: Behavioral: Father-Preterm Newborn Bonding Program |
| Control group | No intervention | Routine nursing care will be applied |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Data will be collected two times as pre-intervention and immediately post-intervention.
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Data will be collected two times as pre-intervention and immediately post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2024
- Study start15 Nov 2023
- Primary completion15 May 2024
- Study completion17 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PretermStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Uğur Gül, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06186453
- Sponsor's protocol ID
- Akdeniz Nursing Faculty
- Status last verified
- Aug 2024
- First submitted
- 16 Dec 2023
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Bonding-Based Education Intervention for Fathers With Preterm Newborn Infants: Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT06186453
- Acronym / sponsor ID
- Akdeniz Nursing Faculty
- Keywords
- Father, Bonding, Neonatal Intensive Care Unit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 17 Jul 2024 (actual)
- First posted
- 2 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Father-Preterm Newborn Bonding ProgramFather-Preterm Newborn Bonding Program |
| Control group | No intervention | –Routine nursing care will be applied |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Characteristics of the father; Has a diagnosed psychiatric diagnosis Having twin preterm newborns
- Characteristics of the preterm newborn Intubated
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Father-Preterm Newborn Bonding ProgramB-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. | Behavioural | Intervention group |
Primary outcome
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.
3 secondary outcomes
Neonatal Intensive Care Unit Parent Stress Scale
Time frame: 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.
Neonatal Stress Scale
Time frame: Data will be collected two times as pre-intervention and immediately post-intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Father-Preterm Newborn Bonding Program in people with Preterm and Bonding, run by Akdeniz University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Father Support Scale: Neonatal Intensive Care Unit (time frame: Data will be collected two times as pre-intervention and immediately post-intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2024.