Examining a Mobile App's Impact on Expectant Fathers' Fear of Childbirth and Paternal Attachment

NCT06168656 | Unknown DMC

• 1 other identifier: E-60116787-020-301336
• Study Type: interventional
• Target: 54
• Locations: 0 countries
• Sites: N/A

Brief Summary

Historically, reproduction and childbirth have conventionally been seen solely as a transition into motherhood and as matters primarily concerning the women. Expectant fathers often experience fear and stress in the perinatal period. Gender roles dictate that men should exude strength and self-assuredness. Hence, it leads expectant fathers to withhold their fears and emotions. Expectant fathers seek specific information about the process and may struggle with emotional expression. Fathers who overlook their own needs are unable to provide adequate support to their partners. Consequently, expectant mothers are more prone to experiencing heightened levels of stress, anxiety, and depression, and they may lean towards opting for cesarean deliveries. Additionally, they might persist in engaging in risky behaviors, such as smoking, and face challenges in maintaining breastfeeding. Support provided to expectant fathers leads to a positive influence on the health of both mothers and newborns. The development of technology has led to significant increase in the utilization of mobile devices within the healthcare. The implementation of mobile device interventions does not increase the workload on institutions and healthcare professionals. Hence, it can be utilized to address the needs of expectant fathers. For this reason, the aim of this study is to develop a mobile application to reduce expectant fathers' fear of childbirth and enhance paternal attachment.

Conditions

Mobile Application; Expectant Fathers; Antenatal Education

Keywords

Mobile application; Antenatal Education; Fatherhood; Mobile Health

Outcome Measures

Primary Outcomes (4)

• Fear of Birth Scale (FOBS)

  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

  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

  This form includes sociodemographic questions such as age, gestational week, education level, employment status, and economic situation.

  Baseline

• Mobile Application Evaluation Form

  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.

Study Arms (2)

Experimental

EXPERIMENTAL

The experimental group will use a mobile application intervention developed for expectant fathers.

Behavioral: Mobile Application

No Intervention

NO INTERVENTION

Control group receive routine care.

Interventions

Mobile Application BEHAVIORAL

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.

Experimental

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Expectant Fathers
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pamukkale University: lead

Central Study Contacts

Büşra Değirmenciler, MSc

CONTACT

05385476202; bdegirmenciler@pau.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: Single blind pre-post test randomized controlled design

Study Record Dates

• First Submitted: December 5, 2023
• First Posted: December 13, 2023
• Study Start: December 31, 2023
• Primary Completion: March 30, 2024
• Study Completion: August 30, 2024
• Last Updated: December 13, 2023

Record last verified: 2023-12