HRAD-Vascular Access

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

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.

Study Overview

• Status: Completed
• Conditions: Anxiety; Vascular Access
• Intervention / Treatment: Other: No intervention

• Study Type: Observational
• Enrollment (Actual): 101

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Lucile Packard Childrens Hospital Stanford

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients undergo vascular access procedure.

Description

Inclusion Criteria:

• participants who is undergoing vascular access

Exclusion Criteria:

• Clinically unstable

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Vascular Access; Patients undergo vascular access procedure.	Other: No intervention; There will be no intervention apply to study participants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation of HRAD± to mYPAS 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.	during vascular access procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation of HRAD± to OBDS-R 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. OSBD-R contains 8 items (information seeking, crying, screaming, restraint, verbal resistance, emotional support, verbal pain, flail)	during vascular access procedure

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Study Director: Thomas Caruso, MD, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2023
• Primary Completion (Actual): June 11, 2023
• Study Completion (Actual): June 10, 2024

Study Registration Dates

• First Submitted: February 8, 2023
• First Submitted That Met QC Criteria: February 8, 2023
• First Posted (Actual): February 17, 2023

Study Record Updates

• Last Update Posted (Actual): June 13, 2024
• Last Update Submitted That Met QC Criteria: June 11, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 68986

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No