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

December 5, 2023 updated by: Busra Degirmenciler, Pamukkale University

Investigating the Effects of Mobile Application for Expectant Fathers About Preparation for Birth and Parenthood on Fear of Childbirth and Paternal Attachment

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
54

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental
The experimental group will use a mobile application intervention developed for expectant fathers.
Behavioral: 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.
No Intervention: No Intervention
Control group receive routine care.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pamukkale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 31, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 5, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2023

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 13, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 13, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • E-60116787-020-301336

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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