Preoperative Educational Videos Reduce Maternal Anxiety Whose Children Received Congenital Heart Disease Surgery

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

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.

Study Overview

• Status: Completed
• Conditions: Surgery; Congenital Heart Disease in Children; Maternal Depression; Educational Videos; Maternal Anxiety
• Intervention / Treatment: Other: Preoperative educational videos plus routine education; Other: Preoperative routine education

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan
    • Chung Shan Medical University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 23 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: study group; mothers receiving routine education plus digital video disk before surgery	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.
Other: control group; mothers receiving routine education	Other: Preoperative 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	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	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)

Collaborators and Investigators

• Sponsor: Chung Shan Medical University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: June 7, 2021
• First Submitted That Met QC Criteria: July 7, 2021
• First Posted (Actual): July 19, 2021

Study Record Updates

• Last Update Posted (Actual): July 19, 2021
• Last Update Submitted That Met QC Criteria: July 7, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Heart Defects, Congenital
• Other Study ID Numbers: CS13143

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No