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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06107491
• Other study ID #: CS1-21113
• Status: Completed
• Phase: N/A
• Start date: October 4, 2021
• Est. completion date: January 1, 2023

Study information

• Verified date: January 2023
• Source: Chung Shan Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 1, 2023
• Est. primary completion date: October 3, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 48 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Children
• Congenital Heart Disease
• COVID-19
• Depression
• Heart Defects, Congenital
• Heart Diseases
• Maternal
• Uncertainty

Intervention

Other:
• Preoperative educational videos plus routine education
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.
• Preoperative routine education
Mothers receiving routine education before their children receiving congenital heart disease surgery

Locations

Country	Name	City	State
Taiwan	Chung Shan Medical University Hospital.	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
Chung Shan Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change of Mother's uncertainty	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)
Primary	The change of Mother's anxiety	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)
Primary	The change of Mother's depression	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)