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Clinical Trials/NCT05733637
NCT05733637
Completed
Not Applicable

Validation of a Novel Anxiety Scale (HRAD) During Vascular Access Procedures

Stanford University1 site in 1 country101 target enrollmentJune 8, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anxiety
Sponsor
Stanford University
Enrollment
101
Locations
1
Primary Endpoint
Correlation of HRAD± to mYPAS during vascular access procedure
Status
Completed
Last Updated
last year

Overview

Brief Summary

The perioperative setting is a common site of pediatric anxiety and distress. Perioperative anxiety in pediatric patients can result in uncooperative behavior, poor postoperative outcomes, and trauma. Given the fast-paced nature of the perioperative environment, many anxiety measures are too time consuming for clinical implementation prior to surgery. Pediatric anesthesiologists need reliable and efficient assessment tools to quickly measure childhood distress to target prophylactic and therapeutic interventions.

Registry
clinicaltrials.gov
Start Date
June 8, 2023
End Date
June 10, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Thomas Caruso

Clinical Professor

Stanford University

Eligibility Criteria

Inclusion Criteria

  • participants who is undergoing vascular access

Exclusion Criteria

  • Clinically unstable

Outcomes

Primary Outcomes

Correlation of HRAD± to mYPAS during vascular access procedure

Time Frame: during vascular access procedure

Correlation between HRAD and mYPAS was assessed by using Fleiss' Kappa. HRAD contains 5-item scale assessing participant's affective state; happy, relaxed, anxious, distressed, with a yes/no answer to cooperation. mYPAS contains 5 items (activity, vocalisation, emotional expressivity, state of apparent arousal, and use of parent). The total score ranges from 0 to 22. Higher scores mean higher levels of anxiety.

Secondary Outcomes

  • Correlation of HRAD± to OBDS-R during vascular access procedure(during vascular access procedure)

Study Sites (1)

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