NCT06384768

Brief Summary

This study aimed to evaluate the effect of an online video training on fears surrounding childbirth given to male partners before the pregnancy of their spouses. The study conducted with 43 male (22 intervention; 21 control) participants. Participants were divided into intervention and control groups. The intervention group was given video training on pregnancy and the birth process. \"Descriptive Information Form\" and the "Male-Childbirth Fear Prior to Pregnancy Scale" was used for data collection. Before the intervention, it was found that the fear level of childbirth was low. The video training given to male partners before the pregnancy of their spouses diminished the fear of birth but did not create a significant difference. These findings support long-term training that includes video tutorials for parents before birth. Interactive, participatory birth preparation training is likely to enhance the training's appeal for male partners.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2022

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

April 23, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 25, 2024

Completed
Last Updated

April 26, 2024

Status Verified

April 1, 2024

Enrollment Period

3 months

First QC Date

April 23, 2024

Last Update Submit

April 25, 2024

Conditions

Keywords

fearbirthpregnancymaleonline support

Outcome Measures

Primary Outcomes (1)

  • Fear of Childbirth

    Pre-pregnancy fear of childbirth

    From enrollment to the end of the training at 4 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

The arm that which was given an online video training

Other: Video training

Control

NO INTERVENTION

No intervention was applied

Interventions

A 4 week support program consist of videos for fear of childbirth

Intervention

Eligibility Criteria

Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMen who have non-pregnant wives.
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • (i) must be married (ii) must be male gender (iii) must participate voluntarily

You may not qualify if:

  • (i) to have a spouse who had been previously pregnant or having a living child.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istinye University

Istanbul, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Student

Study Record Dates

First Submitted

April 23, 2024

First Posted

April 25, 2024

Study Start

February 1, 2022

Primary Completion

May 1, 2022

Study Completion

August 30, 2022

Last Updated

April 26, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Ethical reasons

Locations