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Clinical Trials/NCT04966312
NCT04966312
Completed
Not Applicable

Instructor School of Nursing, Chung Shan Medical University, Taichung, Taiwan

Chung Shan Medical University Hospital1 site in 1 country120 target enrollmentJanuary 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Educational Videos
Sponsor
Chung Shan Medical University Hospital
Enrollment
120
Locations
1
Primary Endpoint
The change of Mother's anxiety
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

To examine if educational digital video disk can reduce maternal anxiety and depression if their children undergo congenital heart disease surgery and when surgical or post-surgical complications occur. Compared to only routine education, adding digital video disk could decrease mothers' anxiety more after education, and until the day of discharge. Compared to only routine education, adding digital video disk could decrease mothers' anxiety more on the discharge day if their child had surgical or post-surgical complications.

Detailed Description

Aims and objectives: To examine if educational digital video disk can reduce maternal anxiety and depression if their children undergo congenital heart disease surgery and when surgical or post-surgical complications occur. Background: Mothers experience anxiety and depression if their children undergo conditions mentioned above. Design: A randomized control-group pretest-posttest design. The CONSORT checklist is used. Methods: In a teaching hospital, 120 mothers whose children underwent first elective surgery for congenital heart disease were randomly divided into group 1: 60 mothers receiving routine education plus digital video disk before surgery; and group 2: 60 mothers receiving routine education. Between groups, mothers' anxiety and depression levels were compared (1) before education, (2) after education (before surgery) and (3) on the discharge day. Among mothers whose children had surgical or post-surgical complications, the effect of watching the digital video disk on anxiety and depression at discharge day was evaluated.

Registry
clinicaltrials.gov
Start Date
January 1, 2017
End Date
December 31, 2019
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor Investigator
Principal Investigator

Chung Shan Medical University Hospital

Department of pediatrics

Chung Shan Medical University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

The change of Mother's anxiety

Time Frame: day 1 (baseline, before education), day 1 (after education), day 5-7 (discharge day)

The number scores of mother's anxiety between "routine education" and "routine plus DVD education" groups. Beck Anxiety Inventory (BAI) was used to evaluate the number scores of anxiety.

The change of Mother's depression

Time Frame: day 1 (baseline, before education), day 1 (after education), day 5-7 (discharge day)

The number scores of mother's depression between "routine education" and "routine plus DVD education" groups. Beck Depression Inventory (BDI) was used to evaluate the number scores of depression.

Study Sites (1)

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