Attachment DisorderNCT06663579
The Effect of Kangaroo Care Method On The Self-Confıdence and Attachment Levels of Fathers of Preterm Babies
A study testing Fathers who practicing kangaroo care in people with Attachment Disorder, run by Biruni University at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted as a randomized controlled experimental type to evaluate the confidence and attachment levels of fathers in baby care whose babies were treated in the neonatal intensive care unit. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Attachment Disorder
- What is being tested?
- Fathers who practicing kangaroo care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Nov 2023to 28 May 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- For Newborns:
- Being a newborn treated in the Istanbul Başakşehir Çam and Sakura Hospital Neonatal Intensive Care Unit
- Gestational age less than 37 weeks
- Postnatal age between 0-28 days
- The baby is considered stable by a neonatologist
- The baby can maintain body temperature during Kangaroo Care
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- Safety is ensured if there is an existing umbilical or central catheter
- For fathers:
- Agreeing to practice Kangaroo Care
- Having no health condition that would prevent practicing Kangaroo Care
- Being able to maintain sufficient hygiene conditions for Kangaroo Care
- Being literate
- Being able to communicate in Turkish
Who cannot join
- For babies:
- Receiving respiratory support
- Having a chest tube
- Having a congenital anomaly
- Using sedative medication
- Having undergone surgery
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- For fathers:
- Not wanting to practice Kangaroo Care
- Using substances that cause sedation (drugs, alcohol)
- Having a disease that can be transmitted through skin contact
- Not agreeing to participate in the study
- Not living in the same house as the baby
Trial locations and contacts
1 site in 1 country.
About this study
This study was conducted as a randomized controlled experimental type to evaluate the confidence and attachment levels of fathers in baby care whose babies were treated in the neonatal intensive care unit.
- Conditions
- Attachment Disorder
- Being tested
- Fathers who practicing kangaroo care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fathers who practicing kangaroo careOther
The study group (n=28) It consists of fathers of babies practicing Kangaroo Care with both their mothers and fathers in the neonatal intensive care unit.
| Study group | Role | What they receive |
|---|---|---|
| Study group: Fathers who practicing kangaroo care | Experimental | The premature babies treated in the neonatal intensive care unit where the study was conducted practice kangaroo care with their mothers. However, in the intervention conducted by the researcher, the babies practiced kangaroo care with both their mothers and fathers. Receives: Other: Fathers who practicing kangaroo care |
| Control group: Fathers who not practicing kangaroo care | No intervention | The premature babies treated in the neonatal intensive care unit where the study was conducted practice kangaroo care with their mothers. However, in the intervention conducted by the researcher, the babies practiced kangaroo care with both their mothers and fathers. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Paternal-Infant Attachment Scale
The scale developed to assess father-infant bonding after birth is a 19-item scale. It consists of three subdimensions: 'patience and tolerance,' 'enjoyment in interaction,' and 'love and pride'. Twelve items in the scale are reverse-coded. Higher scores indicate a higher level of bonding. While the original version of the scale consists of 19 items, the Turkish version comprises 18 items. The Cronbach's alpha coefficient of the scale was reported to be 0.81 at 6 months and 0.78 at 12 months.
Measured: This assessment scale will be administered to the father one month following the baby's discharge from the hospital.
Secondary outcomes (1)
Karitane Parenting Confidence Scale
The scale, originally developed by Crncec and colleagues in 2008, was adapted into Turkish by Yılmaz and Oskay in 2021. It is used to assess the self-confidence of parents regarding their parenting abilities and consists of 14 items designed for parents with infants aged 0 to 12 months. The scale includes two sub-dimensions: "Infant Care" and "Parenting Role." Only Item 11 is reverse scored, with the following scoring pattern: 0 = 3; 1 = 2; 2 = 1; 3 = 0. The total score ranges from 0 to 42, with higher scores indicating a more positive outcome and reflecting higher levels of parental self-confidence.
Measured: This assessment scale will be administered to the father one month following the baby's discharge from the hospital.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start28 Nov 2023
- Primary completion28 May 2024
- Study completion28 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attachment DisorderStudies of the same condition, open and under way.
- More trials run by Biruni UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selmin Kose, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06663579
- Sponsor's protocol ID
- Biruni Universitesi
- Status last verified
- May 2024
- First submitted
- 17 Oct 2024
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to Hospital policy, the individual participant data can not be shared with anyone except researchers.
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Kangaroo Care Method On The Self-Confıdence and Attachment Levels of Fathers of Preterm Babies
- ClinicalTrials.gov ID
- NCT06663579
- Acronym / sponsor ID
- Biruni Universitesi
- Conditions
- Attachment Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Study start
- 28 Nov 2023 (actual)
- Primary completion
- 28 May 2024 (actual)
- Study completion
- 28 May 2024 (actual)
- First posted
- 29 Oct 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.
This study was conducted as a randomized controlled experimental type to evaluate the confidence and attachment levels of fathers in baby care whose babies were treated in the neonatal intensive care unit.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group: Fathers who practicing kangaroo care | Experimental | Other: Fathers who practicing kangaroo careThe premature babies treated in the neonatal intensive care unit where the study was conducted practice kangaroo care with their mothers. However, in the intervention conducted by the researcher, the babies practiced kangaroo care with both their mothers and fathers. |
| Control group: Fathers who not practicing kangaroo care | No intervention | –The premature babies treated in the neonatal intensive care unit where the study was conducted practice kangaroo care with their mothers. However, in the intervention conducted by the researcher, the babies practiced kangaroo care with both their mothers and fathers. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- Being a newborn treated in the Istanbul Başakşehir Çam and Sakura Hospital Neonatal Intensive Care Unit
- Gestational age less than 37 weeks
- Postnatal age between 0-28 days
- The baby is considered stable by a neonatologist
- The baby can maintain body temperature during Kangaroo Care
Key exclusion criteria (12 listed)
- Receiving respiratory support
- Having a chest tube
- Having a congenital anomaly
- Using sedative medication
- Having undergone surgery
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 |
|---|---|---|
| Fathers who practicing kangaroo careThe study group (n=28) It consists of fathers of babies practicing Kangaroo Care with both their mothers and fathers in the neonatal intensive care unit. | Other | Study group: Fathers who practicing kangaroo care |
Primary outcome
Paternal-Infant Attachment Scale
Time frame: This assessment scale will be administered to the father one month following the baby's discharge from the hospital.
The scale developed to assess father-infant bonding after birth is a 19-item scale. It consists of three subdimensions: 'patience and tolerance,' 'enjoyment in interaction,' and 'love and pride'. Twelve items in the scale are reverse-coded. Higher scores indicate a higher level of bonding. While the original version of the scale consists of 19 items, the Turkish version comprises 18 items. The Cronbach's alpha coefficient of the scale was reported to be 0.81 at 6 months and 0.78 at 12 months.
1 secondary outcome
Karitane Parenting Confidence Scale
Time frame: This assessment scale will be administered to the father one month following the baby's discharge from the hospital.
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 9 Apr 2025.
- Individual participant dataSharing planned: No. Due to Hospital policy, the individual participant data can not be shared with anyone except researchers.
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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 Fathers who practicing kangaroo care in people with Attachment Disorder, run by Biruni 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 13 inclusion and 12 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 9 Apr 2025. 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?
Paternal-Infant Attachment Scale (time frame: This assessment scale will be administered to the father one month following the baby's discharge from the hospital.). 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 9 Apr 2025.