Clinical trial NCT04966312: Preoperative Educational Videos Reduce Maternal Anxiety Whose Children Received Congenital Heart Disease Surgery
Official title: Instructor School of Nursing, Chung Shan Medical University, Taichung, Taiwan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Educational Videos
Maternal Anxiety
Surgery
Congenital Heart Disease in Children
Maternal Depression
Lead sponsor: Chung Shan Medical University
Sponsor class: OTHER
First posted: 2021-07-19
Enrollment: 120
Sex: FEMALE
Minimum age (years): 23
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Detailed description: Aims and objectives: 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.

Background: Mothers experience anxiety and depression if their children undergo conditions mentioned above.

Design: A randomized control-group pretest-posttest design. The CONSORT checklist is used.

Methods: 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' 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 anxiety and depression at discharge day was evaluated.

Eligibility criteria: 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

Primary outcomes:
measure: The change of Mother's anxiety
timeFrame: day 1 (baseline, before education), day 1 (after education), day 5-7 (discharge day)
measure: The change of Mother's depression
timeFrame: day 1 (baseline, before education), day 1 (after education), day 5-7 (discharge day)
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital
Study officials:
References: