Clinical trial NCT06168656: Examining a Mobile App's Impact on Expectant Fathers' Fear of Childbirth and Paternal Attachment
Official title: Investigating the Effects of Mobile Application for Expectant Fathers About Preparation for Birth and Parenthood on Fear of Childbirth and Paternal Attachment
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Mobile Application
Expectant Fathers
Antenatal Education
Keywords: Mobile application
Antenatal Education
Fatherhood
Mobile Health
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2023-12-13
Enrollment: 54
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single blind pre-post test randomized controlled design
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: This study was planned as a parallel, single-blind, pre-post-test randomized controlled experimental study in which two groups (experiment-control) will be compared. The block randomization method will be used. The expectant fathers who will participate in the research will be reached through social media networks related to parenthood (Facebook and Instagram accounts) and the data will be collected from expectant fathers who are suitable for the sample characteristics through mobile application. The sample size was calculated in the G\*power statistics program by utilizing the data of a study in which on expectant parents using a mobile application intervention was previously performed (α =0.05, d=0.80). Accordingly, it was found that 16 expectant fathers should be taken for each group to sampling for 80% power. Considering that there might be losses, the number of samples was increased by 40% and it was planned to include a total of 54 expectant fathers in the study. Intention-to-treat analysis will be performed to manage bias and losses. A pilot application will be conducted for 4 weeks with 6 expectant fathers regarding the usability of the mobile application and these expectant fathers will not be included in the study. At the end of 4 weeks, feedback will be received from the expectant fathers participating in the pilot application with the mobile application evaluation form. Necessary changes will be made in the mobile application in line with the feedback.

Eligibility criteria: 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.

Primary outcomes:
measure: Fear of Birth Scale (FOBS)
timeFrame: Baseline and 6 weeks after
measure: Paternal Antenatal Attachment Scale-PAAS
timeFrame: Baseline and 6 weeks after
measure: Introductory Information Form
timeFrame: Baseline
measure: Mobile Application Evaluation Form
timeFrame: 4 weeks after the pilot intervention.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: