Impact of Systematic Nursing Guidance on the Psychological Effects of Parents of Children With Cardiac Catheterization.

Sponsor
Chung Shan Medical University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05496803
Collaborator
(none)
100
1
2
11.1
9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: routine education plus digital video disk
  • Other: routine education
N/A

Detailed Description

Aims and objectives: 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.

Background: Parents experience uncertainty and anxiety when their children undergo conditions mentioned above.

Design: A randomized control-group pretest-posttest design. Methods: In a teaching hospital, 50 fathers and 50 mothers whose children (n=50) underwent first elective catheterization for congenital heart disease were randomly divided into group 1: 25 fathers and 25 mothers receiving routine education plus digital video disk before catheterization; and group 2: 25 fathers and 25 mothers receiving routine education before catheterization. Between groups, parental uncertainty and anxiety levels were compared (1) before education, (2) after education (before catheterization) and (3) on the discharge day (after catheterization). Among mothers whose children had catheterization or post- catheterization complications, the effect of watching the digital video disk on uncertainty and anxiety at discharge day was evaluated.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Other
Official Title:
Chung Shan Medical University Hospital
Actual Study Start Date :
Jul 27, 2022
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Other: study group

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

Other: routine education plus digital video disk
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.

Other: control group

parents receiving routine education: pre-catheterization routine education

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

Outcome Measures

Primary Outcome Measures

  1. The change of parental uncertainty [day 1 (baseline, before education), day 1 (after education), day 2-5 (discharge day)]

    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.

  2. The change of parental anxiety 1 [day 1 (baseline, before education), day 1 (after education), day 2-5 (discharge day)]

    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.

  3. The change of parental anxiety 2 [day 1 (baseline, before education), day 1 (after education), day 2-5 (discharge day)]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 48 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • 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

Exclusion Criteria:
  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chung Shan Medical University Hospital. Taichung Taiwan

Sponsors and Collaborators

  • Chung Shan Medical University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Chung Shan Medical University Hospital, Department of pediatrics, Chung Shan Medical University
ClinicalTrials.gov Identifier:
NCT05496803
Other Study ID Numbers:
  • CS2-22078
First Posted:
Aug 11, 2022
Last Update Posted:
Aug 11, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 11, 2022