Impact of Systematic Nursing Guidance on the Psychological Effects of Parents of Children With Cardiac Catheterization.
Chung Shan Medical University Hospital
1 other identifier
interventional
100
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2022
1 active site
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
July 27, 2022
CompletedFirst Submitted
Initial submission to the registry
August 3, 2022
CompletedFirst Posted
Study publicly available on registry
August 11, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2023
CompletedAugust 11, 2022
August 1, 2022
11 months
August 3, 2022
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
OTHERparents receiving routine education plus digital video disk before catheterization:pre-catheterization educational videos plus routine education
control group
OTHERparents receiving routine education: pre-catheterization 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.
Parents receiving routine education before their children receiving congenital heart disease catheterization
Eligibility Criteria
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
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