Preoperative Educational Videos on Maternal Stress Whose Children Received Congenital Heart Disease Surgery: During COVID-19 Panic

October 26, 2023 updated by: Chung Shan Medical University

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

During COVID-19 panic, we examined if educational digital video disk can reduce maternal uncertainty, 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' uncertainty and anxiety more after education, and until the day of discharge. Compared to only routine education, adding digital video disk could decrease mothers' uncertainty and anxiety more on the discharge day if their child had surgical or post-surgical complications.

Study Overview

Detailed Description

Aims and objectives: During COVID-19 panic, we examined if educational digital video disk can reduce maternal uncertainty, anxiety and depression if their children undergo congenital heart disease surgery and when surgical or post-surgical complications occur.

Background: Mothers experience uncertainty, anxiety and depression if their children undergo conditions mentioned above. Such stress would be more during COVID-19 panic. Design: A randomized control-group pretest-posttest design. The CONSORT checklist is used. Methods: During COVID-19 panic, 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' uncertainty, 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 uncertainty, anxiety and depression at discharge day was evaluated.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Taichung, Taiwan
        • Chung Shan Medical University Hospital.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: study group
mothers receiving routine education plus digital video disk before surgery
Mothers receiving routine education plus digital video disk before their children receiving congenital heart disease surgery. The 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
mothers receiving routine education
Mothers receiving routine education before their children receiving congenital heart disease surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

day 1 (baseline, before education), day 1 (after education), day 5-7 (discharge day)
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.

day 1 (baseline, before education), day 1 (after education), day 5-7 (discharge day)
The change of Mother's uncertainty
Time Frame: day 1 (baseline, before education), day 1 (after education), day 5-7 (discharge day)

The number scores of mother's uncertainty between "routine education" and "routine plus DVD education" groups.

Mishel's Parent Perceptions of Uncertainty Scale (PPUS) was used to evaluate the number scores of uncertainty.

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Tsai, Chung Shan Medical University Hospital, Taichiung, Taiwan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 4, 2021

Primary Completion (Actual)

October 3, 2022

Study Completion (Actual)

January 1, 2023

Study Registration Dates

First Submitted

October 26, 2023

First Submitted That Met QC Criteria

October 26, 2023

First Posted (Actual)

October 30, 2023

Study Record Updates

Last Update Posted (Actual)

October 30, 2023

Last Update Submitted That Met QC Criteria

October 26, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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