NCT06816186

Brief Summary

Multimedia birth prediction intervention helps mothers and their spouses reduce the number of trips to the hospital, reduce anxiety, and increase self-confidence. A total of 83 couples were accepted for cases, with a 10% attrition rate. so, A total of 95 couples were admitted and divided into the experimental group and the intervention measures were implemented Experimental group. Fill out basic demographic and obstetric variables, self-confidence visual analog scale, situational-trait anxiety scale-situational anxiety part at 37 weeks of pregnancy, at the first visit to the hospital, and one hour after admission to the hospital for delivery

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
190

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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 3, 2024

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 25, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 10, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2025

Completed
Last Updated

August 15, 2025

Status Verified

February 1, 2025

Enrollment Period

1.6 years

First QC Date

December 25, 2024

Last Update Submit

August 11, 2025

Conditions

Keywords

birth signs, anxiety, self-confidence, number of home visits

Outcome Measures

Primary Outcomes (2)

  • Self-Confidence Visual Analog Scale

    0 points represent the lowest self-confidence and 10 points represent the highest self-confidence

    Time range: 37 weeks of pregnancy, first visit to the hospital for examination, one hour of hospitalization

  • Situational-Trait Anxiety Inventory-Situational Anxiety Section

    The range is from "1" for almost never to "4" for almost always, with higher total scores indicating a higher level of anxiety in the individual.

    Time range: 37 weeks of pregnancy, first visit to the hospital for examination, one hour of hospitalization

Study Arms (2)

Multimedia

EXPERIMENTAL

When mothers and their spouses reported to the health classroom on the 37-week prenatal check-up day, while the experimental group will receive general care and multimedia birth control education intervention

Behavioral: multimedia

usual care

PLACEBO COMPARATOR

usual care

Behavioral: Usual Care

Interventions

multimediaBEHAVIORAL

When mothers and their spouses reported to the health classroom on the 37-week prenatal check-up day, the researcher explained the motivation and process of the research. After the women and their spouses agreed to join the study, they were randomly assigned to the experimental group and the control group. The control group will be given general care guidance, while the experimental group will receive general care and multimedia birth control education intervention, and the mothers and their spouses will download and watch the video through Line, an instant messaging software on their mobile phones.

Multimedia
Usual CareBEHAVIORAL

When mothers and their spouses reported to the health classroom on the 37-week prenatal check-up day, The control group will be given general care guidance,

usual care

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
1. Low-risk first-time mothers over 20 years old and their spouses 2. Pregnancy \>37 weeks, pregnancy \<40 weeks 3. Single birth, head position 4. Vaginal producers 5. Those who can listen, speak, read and write Chinese 4\. Diagnosed by a doctor as prenatal mental illness 5. The fetus' condition requires admission to a moderate or severe ward or intensive care unit.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Mackay Memorial Hospital

Hsinchu, Hsinchu, 300, Taiwan

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Multimedia

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Audiovisual AidsEducational TechnologyTechnologyTechnology, Industry, and Agriculture

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 25, 2024

First Posted

February 10, 2025

Study Start

February 3, 2024

Primary Completion

August 31, 2025

Study Completion

August 31, 2025

Last Updated

August 15, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations