NCT05496803

Brief Summary

To examine if adding educational digital video disk to routine education can reduce parental uncertainty and anxiety more if their children undergo congenital heart disease catheterization and when catheterization or post- catheterization complications occur. We want to know, compared to only routine education, if adding digital video disk could decrease parental uncertainty or anxiety more or not.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 27, 2022

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

August 3, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 11, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

August 11, 2022

Status Verified

August 1, 2022

Enrollment Period

11 months

First QC Date

August 3, 2022

Last Update Submit

August 9, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • The change of parental uncertainty

    The scores of parental uncertainty between "routine education" and "routine plus DVD education" groups. parent's perception uncertainty in illness score was used to evaluate the number scores of anxiety.

    day 1 (baseline, before education), day 1 (after education), day 2-5 (discharge day)

  • The change of parental anxiety 1

    The number scores of parental anxiety between "routine education" and "routine plus DVD education" groups. State Anxiety Inventory was used to evaluate the number scores of anxiety.

    day 1 (baseline, before education), day 1 (after education), day 2-5 (discharge day)

  • The change of parental anxiety 2

    The number scores of parental anxiety between "routine education" and "routine plus DVD education" groups. Beck Anxiety Inventory was used to evaluate the number scores of anxiety.

    day 1 (baseline, before education), day 1 (after education), day 2-5 (discharge day)

Study Arms (2)

study group

OTHER

parents receiving routine education plus digital video disk before catheterization:pre-catheterization educational videos plus routine education

Other: routine education plus digital video disk

control group

OTHER

parents receiving routine education: pre-catheterization routine education

Other: routine education

Interventions

Parents receiving routine education plus digital video disk before their children receiving congenital heart disease catheterization. The DVD content was the same as the routine education but was presented audio-visually, and the video was easy to understand by the general public.

study group

Parents receiving routine education before their children receiving congenital heart disease catheterization

control group

Eligibility Criteria

Age20 Years - 48 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Parents whose children underwent first elective cardiac catheterization for congenital heart disease
  • Parents should have been the primary caregivers
  • Parents able to communicate effectively, either orally or in writing

You may not qualify if:

  • Parents of children with genetic disorders
  • Parents of children with non-cardiac congenital anomalies
  • Parents of children with diseases such as cerebral palsy, epilepsy, psychiatric diseases, and chronic lung diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chung Shan Medical University Hospital.

Taichung, Taiwan

RECRUITING

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Department of pediatrics

Study Record Dates

First Submitted

August 3, 2022

First Posted

August 11, 2022

Study Start

July 27, 2022

Primary Completion

July 1, 2023

Study Completion

July 1, 2023

Last Updated

August 11, 2022

Record last verified: 2022-08

Locations