HRAD-Vascular Access

Completed

• Conditions: Anxiety; Vascular Access
• Interventions: Other: No intervention

• Registration Number: NCT05733637
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-08
• Study First Submitted QC: 2023-02-08
• Study First Posted: 2023-02-17
• Study Start: 2023-06-08
• Primary Completion: 2023-06-11
• Status Verified: 2024-06
• Study Completion: 2024-06-10
• Last Update Submitted: 2024-06-11
• Last Update Posted: 2024-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

Inclusion Criteria

• participants who is undergoing vascular access

Exclusion Criteria

• Clinically unstable

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Vascular Access	No intervention	Patients undergo vascular access procedure.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)

Trial Locations

Locations (1)

Lucile Packard Childrens Hospital Stanford; 🇺🇸 Palo Alto, California, United States