HRAD-Vascular Access

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.

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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders Vascular Access

Sex eligibility

All sexes

Study type

Observational

Primary location

Lucile Packard Childrens Hospital Stanford

Palo Alto, California, 94304, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

participants who is undergoing vascular access

Exclusion criteria

Clinically unstable

Treatment and study plan

No intervention

Other

There will be no intervention apply to study participants.

Primary outcomes

Correlation of HRAD± to mYPAS during vascular access procedure

Time frame: 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 outcomes

Correlation of HRAD± to OBDS-R during vascular access procedure

Time frame: 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)

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Important dates

Study start: 2023
Primary completion: 2023
Study completion: 2024
First posted: Feb 17, 2023
Registry last updated: Jun 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed