NCT05733637

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 17, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

June 8, 2023

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 11, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2024

Completed
Last Updated

June 13, 2024

Status Verified

June 1, 2024

Enrollment Period

3 days

First QC Date

February 8, 2023

Last Update Submit

June 11, 2024

Conditions

AnxietyVascular Access

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

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

    during vascular access procedure

Study Arms (1)

Vascular Access

Patients undergo vascular access procedure.

Other: No intervention

Interventions

No interventionOTHER

There will be no intervention apply to study participants.

Vascular Access

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients undergo vascular access procedure.

You may qualify if:

  • participants who is undergoing vascular access

You may not qualify if:

  • Clinically unstable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lucile Packard Childrens Hospital Stanford

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Thomas Caruso, MD

    Stanford University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

February 8, 2023

First Posted

February 17, 2023

Study Start

June 8, 2023

Primary Completion

June 11, 2023

Study Completion

June 10, 2024

Last Updated

June 13, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)