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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05733637
Other study ID # 68986
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 8, 2023
Est. completion date June 10, 2024

Study information

Verified date June 2024
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
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 Completed
Enrollment 101
Est. completion date June 10, 2024
Est. primary completion date June 11, 2023
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

Study Design


Related Conditions & MeSH terms


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
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