Pathernal AttachmentNCT04914858
The Effect of Education Given to Prospective Fathers on Daily Care of the Baby and Father-Infant Attachment
A study testing Education in people with Pathernal Attachment and Effect of Education to Pathernal Attachment, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial summary
I am conducting an experimental study examining the bonding between father and baby. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pathernal Attachment, Effect of Education to Pathernal Attachment
- What is being tested?
- Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jan 2020to 11 Oct 2021
- 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 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Spouse must be in the 3rd trimester of pregnancy
- Father should be father for the first time
- The family must be a citizen of the Republic of Turkey,
- The father's education level must be at least high school and its equivalent.
- Father's age should be between 18-40.
- Father has to have a job (Active employment).
Who cannot join
- Baby must be healthy
- Parents do not have any psychological problems,
Trial locations and contacts
1 site in 1 country.
About this study
I am conducting an experimental study examining the bonding between father and baby.
Read the detailed description
The experimental group and the control group (1st group and 2nd group) will be formed by randomly selecting the spouses of women who applied to Afşin State Hospital and Elbistan State Hospital Gynecology Polyclinic. Fathers in the first group will be met face-to-face with powerpoints and visuals, and training will be provided. It is planned to provide a total of 3 educations by contacting fathers at the time of birth and 2 months after birth. The scope of the 1st education is planned to be about attachment, father-infant attachment, the benefits of father-infant attachment to the baby and the father and how this bond can be strengthened. Care and feeding of the baby is planned within the scope of the second education. In the third education, it is planned to inform the father about spending quality time with the baby and its importance. As a result, the first education will be focused on more about attachment and its importance, the second education will focus on the importance of the father's participation in the care of the baby and the information about care, and the last education the importance of the father's taking care of the baby and spending time with him. Fathers in the second group will be given a training brochure at the end of the 6th month, after the scale is applied. If the baby's health is affected by possible adverse events at birth, that father will be excluded from the study. After the birth with the fathers, when the baby reaches 6-12 months, face-to-face or phone calls will be applied and the father-infant attachment status will be analyzed by statistical analysis. The study will be done as pre-test and post-test. Güleç D. and Kavlak O. examined the validity of the father-infant Attachment Scale in Turkish society, and they came up with a questionnaire consisting of 19 questions in total.
Detail added (15.06.2021): Power analysis was performed with the study from 5 control groups from 5 experimental groups. A total of 58 workers, consisting of 29 experimental and 29 control groups, were found sufficient for the study
- Being tested
- Education
- Keywords
- pathernal attachment, baby, father
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationOther
Its validity and reliability is a reliable scale in Turkey
| Study group | Role | What they receive |
|---|---|---|
| Education group | Experimental | Education Receives: Other: Education |
| Control group | No intervention | No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Is Education of Daily Care of the Baby and Father-Infant Attachment effective?
Validity and reliability in Turkey will be made questionnaire(Pre-test, Post-test),
***In the study, item 16 was removed from the scale after further analysis.
Evaluations are made as stated below:
Items 1, 2 and 3 in the scale are coded as a=1, b= 2, c=3, d=4 and e= 5 points. Items 4. 5. 10. 12. and 14. are reverse coded as a=5, b= 4, c=3, d=2 and e=1. Items 6, 17, 18 and 19 are coded as a=1, b= 2.3, c=3.6, d=5. Items 7. 9. 11. ve 15 are reverse coded as a=5, b=3.6, c=2.3, d=1. 8th item is coded as a=5 b=1 13th item is coded as a=5, b=3, c=1
Measured: About 6 months per a participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start10 Jan 2020
- Primary completion10 Sep 2021
- Study completion11 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pathernal AttachmentStudies 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
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Collaborators
- Cukurova University
- Responsible party
- Principal investigator, Mustafa Kara, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04914858
- Sponsor's protocol ID
- Cukurova University
- Status last verified
- Oct 2021
- First submitted
- 15 May 2021
- Last updated
- 2 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Education Given to Prospective Fathers on Daily Care of the Baby and Father-Infant Attachment
- ClinicalTrials.gov ID
- NCT04914858
- Acronym / sponsor ID
- Cukurova University
- Keywords
- pathernal attachment, baby, father
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Collaborators
- Cukurova University
- Study start
- 10 Jan 2020 (actual)
- Primary completion
- 10 Sep 2021 (actual)
- Study completion
- 11 Oct 2021 (actual)
- First posted
- 7 Jun 2021 (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.
I am conducting an experimental study examining the bonding between father and baby.
Detailed description
The experimental group and the control group (1st group and 2nd group) will be formed by randomly selecting the spouses of women who applied to Afşin State Hospital and Elbistan State Hospital Gynecology Polyclinic. Fathers in the first group will be met face-to-face with powerpoints and visuals, and training will be provided. It is planned to provide a total of 3 educations by contacting fathers at the time of birth and 2 months after birth. The scope of the 1st education is planned to be about attachment, father-infant attachment, the benefits of father-infant attachment to the baby and the father and how this bond can be strengthened. Care and feeding of the baby is planned within the scope of the second education. In the third education, it is planned to inform the father about spending quality time with the baby and its importance. As a result, the first education will be focused on more about attachment and its importance, the second education will focus on the importance of the father's participation in the care of the baby and the information about care, and the last education the importance of the father's taking care of the baby and spending time with him. Fathers in the second group will be given a training brochure at the end of the 6th month, after the scale is applied. If the baby's health is affected by possible adverse events at birth, that father will be excluded from the study. After the birth with the fathers, when the baby reaches 6-12 months, face-to-face or phone calls will be applied and the father-infant attachment status will be analyzed by statistical analysis. The study will be done as pre-test and post-test. Güleç D. and Kavlak O. examined the validity of the father-infant Attachment Scale in Turkish society, and they came up with a questionnaire consisting of 19 questions in total.
Detail added (15.06.2021): Power analysis was performed with the study from 5 control groups from 5 experimental groups. A total of 58 workers, consisting of 29 experimental and 29 control groups, were found sufficient for the study
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Education group | Experimental | Other: EducationEducation |
| Control group | No intervention | –No Intervention |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Spouse must be in the 3rd trimester of pregnancy
- Father should be father for the first time
- The family must be a citizen of the Republic of Turkey,
- The father's education level must be at least high school and its equivalent.
- Father's age should be between 18-40.
Key exclusion criteria (2 listed)
- Baby must be healthy
- Parents do not have any psychological problems,
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 |
|---|---|---|
| EducationIts validity and reliability is a reliable scale in Turkey | Other | Education group |
Primary outcome
Is Education of Daily Care of the Baby and Father-Infant Attachment effective?
Time frame: About 6 months per a participant
Validity and reliability in Turkey will be made questionnaire(Pre-test, Post-test), ***In the study, item 16 was removed from the scale after further analysis. Evaluations are made as stated below: Items 1, 2 and 3 in the scale are coded as a=1, b= 2, c=3, d=4 and e= 5 points. Items 4. 5. 10. 12. and 14. are reverse coded as a=5, b= 4, c=3, d=2 and e=1. Items 6, 17, 18 and 19 are coded as a=1, b= 2.3, c=3.6, d=5. Items 7. 9. 11. ve 15 are reverse coded as a=5, b=3.6, c=2.3, d=1. 8th item is coded as a=5 b=1 13th item is coded as a=5, b=3, c=1
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 2 Nov 2021.
- Individual participant dataSharing planned: Undecided
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 Education in people with Pathernal Attachment and Effect of Education to Pathernal Attachment, run by Kahramanmaras Sutcu Imam 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 6 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 2 Nov 2021. 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?
Is Education of Daily Care of the Baby and Father-Infant Attachment effective? (time frame: About 6 months per a participant). 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 2 Nov 2021.