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

Sponsor
Chung Shan Medical University (Other)
Overall Status
Completed
CT.gov ID
NCT06107491
Collaborator
(none)
120
1
2
14.9
8

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Preoperative educational videos plus routine education
  • Other: Preoperative routine education
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Other
Official Title:
Instructor School of Nursing, Chung Shan Medical University, Taichung, Taiwan
Actual Study Start Date :
Oct 4, 2021
Actual Primary Completion Date :
Oct 3, 2022
Actual Study Completion Date :
Jan 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. The change of Mother's uncertainty [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.

  2. The change of Mother's anxiety [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.

  3. The change of Mother's depression [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 48 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chung Shan Medical University Hospital. Taichung Taiwan

Sponsors and Collaborators

  • Chung Shan Medical University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Chung Shan Medical University
ClinicalTrials.gov Identifier:
NCT06107491
Other Study ID Numbers:
  • CS1-21113
First Posted:
Oct 30, 2023
Last Update Posted:
Oct 30, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 30, 2023