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

NCT ID: NCT06168656

Last Updated: 2023-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-31

Study Completion Date

2024-08-30

Brief Summary

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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

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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.

Conditions

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Mobile Application Expectant Fathers Antenatal Education

Keywords

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Mobile application Antenatal Education Fatherhood Mobile Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Single blind pre-post test randomized controlled design
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants
Single

Study Groups

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Experimental

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

Group Type EXPERIMENTAL

Mobile Application

Intervention Type 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.

No Intervention

Control group receive routine care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mobile Application

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Pamukkale University

OTHER

Sponsor Role lead

Responsible Party

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Busra Degirmenciler

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Büşra Değirmenciler, MSc

Role: CONTACT

Phone: 05385476202

Email: [email protected]

Other Identifiers

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E-60116787-020-301336

Identifier Type: -

Identifier Source: org_study_id