HRAD-Vascular Access

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05733637
• Other study ID #: 68986
• Status: Recruiting
• Start date: June 25, 2023
• Est. completion date: June 14, 2024

Study information

• Verified date: July 2023
• Source: Stanford University
• Contact: Thomas Caruso, MD
• Phone: 650-723-5728
• Email: tjcaruso[@]stanford.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 14, 2024
• Est. primary completion date: June 14, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• participants who is undergoing vascular access

Exclusion Criteria:

• Clinically unstable

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Vascular Access

Intervention

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

Locations

Country	Name	City	State
United States	Lucile Packard Childrens Hospital Stanford	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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