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

Primary Purpose

Educational Videos, Maternal Anxiety, Surgery

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Preoperative educational videos plus routine education
Preoperative routine education
Sponsored by
Chung Shan Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Educational Videos

Eligibility Criteria

23 Years - 48 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Chung Shan Medical University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

study group

control group

Arm Description

mothers receiving routine education plus digital video disk before surgery

mothers receiving routine education

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
June 7, 2021
Last Updated
July 7, 2021
Sponsor
Chung Shan Medical University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04966312
Brief Title
Preoperative Educational Videos Reduce Maternal Anxiety Whose Children Received Congenital Heart Disease Surgery
Official Title
Instructor School of Nursing, Chung Shan Medical University, Taichung, Taiwan
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Chung Shan Medical University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Educational Videos, Maternal Anxiety, Surgery, Congenital Heart Disease in Children, Maternal Depression

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
study group
Arm Type
Other
Arm Description
mothers receiving routine education plus digital video disk before surgery
Arm Title
control group
Arm Type
Other
Arm Description
mothers receiving routine education
Intervention Type
Other
Intervention Name(s)
Preoperative educational videos plus routine education
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Preoperative routine education
Intervention Description
Mothers receiving routine education before their children receiving congenital heart disease surgery
Primary Outcome Measure Information:
Title
The change of Mother's anxiety
Description
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.
Time Frame
day 1 (baseline, before education), day 1 (after education), day 5-7 (discharge day)
Title
The change of Mother's depression
Description
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.
Time Frame
day 1 (baseline, before education), day 1 (after education), day 5-7 (discharge day)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
23 Years
Maximum Age & Unit of Time
48 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Chung Shan Medical University Hospital
City
Taichung
Country
Taiwan

12. IPD Sharing Statement

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

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