HRAD-Vascular Access

Sponsor
Stanford University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05733637
Collaborator
(none)
200
12

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: No intervention

Study Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Other
Time Perspective:
Other
Official Title:
Validation of a Novel Anxiety Scale (HRAD) During Vascular Access Procedures
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Mar 31, 2024
Anticipated Study Completion Date :
Mar 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Vascular Access

Patients undergo vascular access procedure.

Other: No intervention
There will be no intervention apply to study participants.

Outcome Measures

Primary Outcome Measures

  1. Correlation of HRAD± to mYPAS during vascular access procedure [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 Outcome Measures

  1. Correlation of HRAD± to OBDS-R during vascular access procedure [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • participants who is undergoing vascular access
Exclusion Criteria:
  • Clinically unstable

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Stanford University

Investigators

  • Study Director: Thomas Caruso, MD, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Thomas Caruso, Clinical Professor, Stanford University
ClinicalTrials.gov Identifier:
NCT05733637
Other Study ID Numbers:
  • 68986
First Posted:
Feb 17, 2023
Last Update Posted:
Feb 17, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 17, 2023