- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06168656
Examining a Mobile App's Impact on Expectant Fathers' Fear of Childbirth and Paternal Attachment
Investigating the Effects of Mobile Application for Expectant Fathers About Preparation for Birth and Parenthood on Fear of Childbirth and Paternal Attachment
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Büşra Değirmenciler, MSc
- Phone Number: 05385476202
- Email: bdegirmenciler@pau.edu.tr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged 18 and above,
- Users of smartphones and social media,
- Willing to participate in the research,
- Proficient in understanding, speaking, and writing in Turkish,
- At least completed primary education,
- First-time fathers,
- Have not attended any antenatal education program,
- Have internet access and have used any mobile application before,
- Spouses with low-risk pregnancies in the 20-28 weeks gestational age and without a cesarean indication will be eligible for participation.
Exclusion Criteria:
- Fathers who have previously experienced childbirth before the post-test.
- Fathers who wish to withdraw from the research.
- Fathers who do not complete the educational program will be excluded from the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental
The experimental group will use a mobile application intervention developed for expectant fathers.
|
The mobile application will include the following features: Direct Message Section: This section will allow expectant fathers to ask specialized questions directly to experts or specialists. Forum Section: Expectant fathers can use this section to engage in discussions and connect with each other. Education Section: This section is specifically designed to cater to the educational needs of expectant fathers. |
No Intervention: No Intervention
Control group receive routine care.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fear of Birth Scale (FOBS)
Time Frame: Baseline and 6 weeks after
|
This scale was developed by Haines et al. in 2011 to measure the fear of childbirth.
In the scale, the participants were asked to rate their feelings by marking the statements (a) 'calm/worried' (b) 'no fear/strong fear' on two 100 mm lines to answer the question "How do you feel right now about the approaching birth?".
Cronbach's Alpha internal consistency coefficient of the scale was 0.91.
The cut-off score of the scale was 50.
Participants who obtained a score of 50 or above were considered to fear of childbirth.
|
Baseline and 6 weeks after
|
Paternal Antenatal Attachment Scale-PAAS
Time Frame: Baseline and 6 weeks after
|
The PAAS was developed by Condon in 1993.
The scale comprises 16 items.
Each item of the scale focuses on measuring the father's emotions, attitudes, behaviors, and thoughts toward the developing fetus during pregnancy, with most items based on fathers' experiences in the last two weeks.
Items are rated on a five-point Likert scale ranging from 1 to 5, with a total score range of 16-80.
Lower scores indicate less antenatal attachment.
|
Baseline and 6 weeks after
|
Introductory Information Form
Time Frame: Baseline
|
This form includes sociodemographic questions such as age, gestational week, education level, employment status, and economic situation.
|
Baseline
|
Mobile Application Evaluation Form
Time Frame: 4 weeks after the pilot intervention.
|
This researcher-designed form assesses user satisfaction with the mobile app, gathering feedback on usability and content following the pilot application.
|
4 weeks after the pilot intervention.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- E-60116787-020-301336
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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