This trial is active, not recruiting.

Conditions post-operative delirium, children, anxiety
Sponsor National Taiwan University Hospital
Start date December 2013
End date December 2016
Trial size 100 participants
Trial identifier NCT01993992, 201310021RIND


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective

Primary Outcomes

degree of emergence delirium
time frame: after operation, with an average duration up to 24 hours

Secondary Outcomes

recovery room stay time
time frame: after operation, with an average duration up to 24 hours
Sedatives used in recovery room
time frame: after operation, with an average duration up to 24 hours

Eligibility Criteria

Male or female participants up to 16 years old.

Inclusion criteria: - American Society Anesthesia (ASA) risks classification I or II Exclusion criteria: - Parents who have cognitive problems - Parents who have difficulty finishing questionnaire

Additional Information

Official title Parental Anxiety and Its Relationship With Pediatric Patients' Post-operative Responses
Principal investigator YI-CHIA WANG
Description Outcome measures 1. Post-operative emergence delirium, observed with an average duration up to 24 hours 2. Sedatives used in recovery unit
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by National Taiwan University Hospital.