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Completed

NCT Number: NCT06107491

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

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.

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Key information

Conditions

COVID-19 Anxiety Anxiety Disorders Behavior Behavioral Symptoms Cardiovascular Abnormalities Cardiovascular Diseases Children Congenital Abnormalities Congenital Heart Disease Congenital, Hereditary, and Neonatal Diseases and Abnormalities Coronaviridae Infections Coronavirus Infections Depression Educational Videos Heart Defects, Congenital Heart Diseases Infections Lung Diseases Maternal Mental Disorders Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Uncertainty Virus Diseases

Age range

20 year–48 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Chung Shan Medical University Hospital.

Taichung, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Preoperative educational videos plus routine education

Other

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

Other

Mothers receiving routine education before their children receiving congenital heart disease surgery

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Chung Shan Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Oct 30, 2023
Registry last updated
Oct 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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