NCT06107491

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable covid19

Timeline
Completed

Started Oct 2021

Typical duration for not_applicable covid19

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 4, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 3, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 26, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 30, 2023

Completed
Last Updated

October 30, 2023

Status Verified

January 1, 2023

Enrollment Period

12 months

First QC Date

October 26, 2023

Last Update Submit

October 26, 2023

Conditions

COVID-19Educational VideosMaternalUncertaintyAnxietyDepressionCongenital Heart DiseaseChildren

Outcome Measures

Primary Outcomes (3)

  • The change of Mother's uncertainty

    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)

  • 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)

Study Arms (2)

study group

OTHER

mothers receiving routine education plus digital video disk before surgery

Other: Preoperative educational videos plus routine education

control group

OTHER

mothers receiving routine education

Other: Preoperative routine education

Interventions

Preoperative educational videos plus routine educationOTHER

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.

study group
Preoperative routine educationOTHER

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

control group

Eligibility Criteria

Age20 Years - 48 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chung Shan Medical University Hospital.

Taichung, Taiwan

Location

MeSH Terms

Conditions

COVID-19Anxiety DisordersDepressionHeart Defects, Congenital

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesMental DisordersBehavioral SymptomsBehaviorCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Tsai

    Chung Shan Medical University Hospital, Taichiung, Taiwan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2023

First Posted

October 30, 2023

Study Start

October 4, 2021

Primary Completion

October 3, 2022

Study Completion

January 1, 2023

Last Updated

October 30, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)