- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06107491
Preoperative Educational Videos on Maternal Stress Whose Children Received Congenital Heart Disease Surgery: During COVID-19 Panic
Instructor School of Nursing, Chung Shan Medical University, Taichung, Taiwan
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Taichung, Taiwan
- Chung Shan Medical University Hospital.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
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
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
Sponsor
Investigators
- Principal Investigator: Tsai, Chung Shan Medical University Hospital, Taichiung, Taiwan
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Congenital Abnormalities
- Cardiovascular Abnormalities
- Heart Diseases
- COVID-19
- Heart Defects, Congenital
Other Study ID Numbers
- CS1-21113
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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