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

NCT04966312 | Completed

• 1 other identifier: CS13143
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Educational Videos; Maternal Anxiety; Surgery; Congenital Heart Disease in Children; Maternal Depression

Outcome Measures

Primary Outcomes (2)

• 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 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.

study group

Preoperative routine education OTHER

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

control group

Eligibility Criteria

• Age: 23 Years - 48 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (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

Sponsors & Collaborators

• Chung Shan Medical University Hospital: lead

Study Sites (1)

Chung Shan Medical University Hospital

Taichung, Taiwan

Location

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 INVESTIGATOR
• PI Title: Department of pediatrics

Study Record Dates

• First Submitted: June 7, 2021
• First Posted: July 19, 2021
• Study Start: January 1, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: July 19, 2021

Record last verified: 2021-07

Locations

TW (1)