Kangaroo CareNCT06266884
The Effect of Kangaroo Care on Father-Baby Attachment
A study testing Kangaroo care in people with Kangaroo Care and Attachment, run by Agri Ibrahim Cecen University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the research is to evaluate the attachment level of fathers who received kangaroo care training in the antenatal period and applied kangaroo care in the postpartum period to their babies in the first and fourth months.The research will be conducted in a randomized controlled experimental type with… Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Kangaroo Care, Attachment
- What is being tested?
- Kangaroo care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2022to 15 Nov 2023
- 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 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 36-38. Coming to the hospital with her partner between weeks of gestation,
- Not having any physical and/or mental health problems,
- Not having a contagious disease transmitted by contact,
- Agreeing to participate in the research,
- Knowing Turkish and/or not having communication problems,
- Using Whatsapp application,
- Expecting a single baby
Who cannot join
- Being a foreign national, an immigrant or having communication problems,
- Having any physical and/or mental health problems,Having a transient contagious disease through contact,
- Refusing to participate in the research,
- Not using a phone and/or WhatsApp application,
- Expecting more than one baby
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Kangaroo Care Training Given to Expectant Fathers in the Antenatal Period on Postpartum Father-Baby Attachment: Randomized Controlled Study
The aim of the research is to evaluate the attachment level of fathers who received kangaroo care training in the antenatal period and applied kangaroo care in the postpartum period to their babies in the first and fourth months.The research will be conducted in a randomized controlled experimental type with educational intervention. The research will be conducted at Islahiye State Hospital with 25 experimental and 25 control group fathers who meet the inclusion criteria. Fathers in the experimental group will be given kangaroo care training during the antenatal period and postpartum kangaroo care will be applied. No intervention will be made to the control group fathers. The Paternal-Infant Attachment Questionnaire (PPAQ) will be applied to fathers in both groups in the first and fourth months and the results will be compared.
Read the detailed description
The aim of the research is to evaluate the attachment level of fathers who received kangaroo care training in the antenatal period and applied kangaroo care in the postpartum period to their babies in the first and fourth months.The research will be conducted in a randomized controlled experimental type with educational intervention. The research will be conducted at Islahiye State Hospital with 25 experimental and 25 control group fathers who meet the inclusion criteria. Fathers in the experimental group will be given kangaroo care training during the antenatal period and postpartum kangaroo care will be applied. No intervention will be made to the control group fathers. The Paternal-Infant Attachment Questionnaire (PPAQ) will be applied to fathers in both groups in the first and fourth months and the results will be compared.In the study, data will be collected using the father information form, postpartum questionnaire, postpartum kangaroo care competency checklist, kangaroo care application follow-up chart and father-baby attachment scale.
- Conditions
- Kangaroo Care, Attachment
- Being tested
- Kangaroo care
- Keywords
- kangaroo care, Father-infant attachment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kangaroo careOther
Kangaroo care is a safe and effective method in which the baby is placed in an upright position on the parent's bare chest, wearing only a diaper and a hat, and the baby's needs for nutrition, warmth, love and trust are met and provides positive interaction between the parent and the baby.
| Study group | Role | What they receive |
|---|---|---|
| Kangaroo care group | Experimental | The contact numbers of the prospective fathers will be taken and a training video and presentation on kangaroo care will be sent via WhatsApp. Kangaroo care will be applied to the fathers in the experimental group during birth. Receives: Other: Kangaroo care |
| Control Group | No intervention | After the fathers are informed that the birth has started, the postpartum questions prepared for the control group will be sent via WhatsApp and filled in by the fathers within the first 24 hours after birth. No other application will be applied to the control group. Father-Baby Attachment Scale questions will be sent to fathers via WhatsApp in the first and fourth months after birth and their answers will be received. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fathers' Attachment Level
Father-infant attachment scale
Measured: from birth to 4 month after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start15 Dec 2022
- Primary completion15 Jun 2023
- Study completion15 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kangaroo CareStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The contact numbers of the prospective fathers will be taken and a training video and presentation on kangaroo care will be sent via WhatsApp. Kangaroo care will be applied to the fathers in the experimental group during birth.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agri Ibrahim Cecen University
- Sponsor type
- University, hospital or other
- Collaborators
- Kahramanmaras Sutcu Imam University
- Responsible party
- Principal investigator, Emine Serap ÇAĞAN, Agri Ibrahim Cecen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06266884
- Sponsor's protocol ID
- AgriIbrahimCecen
- Status last verified
- Feb 2024
- First submitted
- 12 Feb 2024
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Kangaroo Care Training Given to Expectant Fathers in the Antenatal Period on Postpartum Father-Baby Attachment: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06266884
- Acronym / sponsor ID
- AgriIbrahimCecen
- Conditions
- Kangaroo Care, Attachment
- Keywords
- kangaroo care, Father-infant attachment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Agri Ibrahim Cecen UniversityUniversity, hospital or other
- Collaborators
- Kahramanmaras Sutcu Imam University
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 15 Nov 2023 (actual)
- First posted
- 20 Feb 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 aim of the research is to evaluate the attachment level of fathers who received kangaroo care training in the antenatal period and applied kangaroo care in the postpartum period to their babies in the first and fourth months.The research will be conducted in a randomized controlled experimental type with educational intervention. The research will be conducted at Islahiye State Hospital with 25 experimental and 25 control group fathers who meet the inclusion criteria. Fathers in the experimental group will be given kangaroo care training during the antenatal period and postpartum kangaroo care will be applied. No intervention will be made to the control group fathers. The Paternal-Infant Attachment Questionnaire (PPAQ) will be applied to fathers in both groups in the first and fourth months and the results will be compared.
Detailed description
The aim of the research is to evaluate the attachment level of fathers who received kangaroo care training in the antenatal period and applied kangaroo care in the postpartum period to their babies in the first and fourth months.The research will be conducted in a randomized controlled experimental type with educational intervention. The research will be conducted at Islahiye State Hospital with 25 experimental and 25 control group fathers who meet the inclusion criteria. Fathers in the experimental group will be given kangaroo care training during the antenatal period and postpartum kangaroo care will be applied. No intervention will be made to the control group fathers. The Paternal-Infant Attachment Questionnaire (PPAQ) will be applied to fathers in both groups in the first and fourth months and the results will be compared.In the study, data will be collected using the father information form, postpartum questionnaire, postpartum kangaroo care competency checklist, kangaroo care application follow-up chart and father-baby attachment scale.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The contact numbers of the prospective fathers will be taken and a training video and presentation on kangaroo care will be sent via WhatsApp. Kangaroo care will be applied to the fathers in the experimental group during birth.
| Arm | Type | Receives |
|---|---|---|
| Kangaroo care group | Experimental | Other: Kangaroo careThe contact numbers of the prospective fathers will be taken and a training video and presentation on kangaroo care will be sent via WhatsApp. Kangaroo care will be applied to the fathers in the experimental group during birth. |
| Control Group | No intervention | –After the fathers are informed that the birth has started, the postpartum questions prepared for the control group will be sent via WhatsApp and filled in by the fathers within the first 24 hours after birth. No other application will be applied to the control group. Father-Baby Attachment Scale questions will be sent to fathers via WhatsApp in the first and fourth months after birth and their answers will be received. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 36-38. Coming to the hospital with her partner between weeks of gestation,
- Not having any physical and/or mental health problems,
- Not having a contagious disease transmitted by contact,
- Agreeing to participate in the research,
- Knowing Turkish and/or not having communication problems,
Key exclusion criteria (5 listed)
- Being a foreign national, an immigrant or having communication problems,
- Having any physical and/or mental health problems,Having a transient contagious disease through contact,
- Refusing to participate in the research,
- Not using a phone and/or WhatsApp application,
- Expecting more than one baby
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 |
|---|---|---|
| Kangaroo careKangaroo care is a safe and effective method in which the baby is placed in an upright position on the parent's bare chest, wearing only a diaper and a hat, and the baby's needs for nutrition, warmth, love and trust are met and provides positive interaction between the parent and the baby. | Other | Kangaroo care group |
Primary outcome
Fathers' Attachment Level
Time frame: from birth to 4 month after birth
Father-infant attachment scale
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 20 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Kangaroo Care
Active, not recruiting
Maternal Sensory Interventions in Newborns
Neonatal Intensive Care Unit, Hospitalized Newborn
Recruiting
Admission to Kangaroo Mother Care (KMC) Ward and Maternal Postpartum Depression
Low Birth Weight, Kangaroo Mother Care
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The Effect of Kangaroo Care on Pain in Infants Receiving Phototherapy
Procedural Pain, Neonatal Hyperbilirubinemia
Not yet recruiting
The Effect of the Side Kangaroo Position in Newborns Undergoing Noninvasive Mechanical Ventilation
Newborn Care
Active, not recruiting
Effect of Kangaroo Mother Care on Energy Utilization in Preterm Neonates
Impact of Kangroo on Neonates
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 Kangaroo care in people with Kangaroo Care and Attachment, run by Agri Ibrahim Cecen 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 7 inclusion and 5 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 20 Feb 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?
Fathers' Attachment Level (time frame: from birth to 4 month after birth). 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 20 Feb 2024.