Parental Anxiety and Its Relationship With Pediatric Patients' Post-operative Responses

Anxiety Clinical Trial

Official title:

Parental Anxiety and Its Relationship With Pediatric Patients' Post-operative Responses

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01993992
• Other study ID #: 201310021RIND
• Status: Active, not recruiting
• Phase: N/A
• First received: November 3, 2013
• Last updated: July 7, 2015
• Start date: December 2013
• Est. completion date: December 2016

Study information

• Verified date: July 2015
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial Summary

Post-operative delirium had multiple risk factors, such as pre-operative anxiety status, post-operative pain, and anesthetic method. We currently decrease pre-operative anxiety by parental accompanying until the children put to sleep. However, references indicate that parental anxiety can increase the post-operative delirium. Heart rate variability was used to measure the anxiety status of parents. We think sympathetic tone elevation measured by heart rate variability may not induce by anxiety alone, thus we want to explore this question by using Stat-Trait Anxiety Inventory questionnaire.

Description:

Outcome measures

1. Post-operative emergence delirium, observed with an average duration up to 24 hours

2. Sedatives used in recovery unit

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 16 Years

Eligibility

Inclusion criteria:

• American Society Anesthesia (ASA) risks classification I or II

Exclusion criteria:

• Parents who have cognitive problems

• Parents who have difficulty finishing questionnaire

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Children
• Post-operative Delirium

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	degree of emergence delirium		after operation, with an average duration up to 24 hours	No
Secondary	recovery room stay time		after operation, with an average duration up to 24 hours	No
Secondary	Sedatives used in recovery room		after operation, with an average duration up to 24 hours	No