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Clinical Trials/NCT05708586
NCT05708586
Terminated
N/A

Virtual Reality Decreases Child Anxiety and Pain as Well as Caregiver Anxiety and Pain Perception During Orthopaedic Clinic Office Procedures

University of Michigan1 site in 1 country66 target enrollmentDecember 8, 2021
ConditionsAnxietyPain

Overview

Phase
N/A
Intervention
Not specified
Conditions
Anxiety
Sponsor
University of Michigan
Enrollment
66
Locations
1
Primary Endpoint
Child Anxiety (7 Years Old and Older)
Status
Terminated
Last Updated
2 years ago

Overview

Brief Summary

The purpose of this study is to demonstrate that the use of a virtual reality experience can decrease child and caregiver anxiety and pain for simple orthopaedic office procedures.

Registry
clinicaltrials.gov
Start Date
December 8, 2021
End Date
January 25, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Noelle Whyte

Clinical Assistant Professor

University of Michigan

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Child Anxiety (7 Years Old and Older)

Time Frame: Up to 24 hours following procedure

Assessed by State-Trait Anxiety Inventory for Children (STAIC): 20 questions with 3 answer options for each question. Scores range from 20 to 60 with 60 being the higher (more or worse) anxiety on self-assessment.

Child Pain Score

Time Frame: Up to 24 hours following procedure

Assessed by Wong-Baker Children's Faces Pain Scale: The scale shows a series of faces ranging from a happy face at 0 which represents "no hurt" to a crying face at 10 which represents "hurts worst." Based on the faces and descriptions, the patient chooses the face that best describes their level of pain.

Child Anxiety (Younger Than 7 Years Old)

Time Frame: Up to 24 hours following procedure

Assessed by Children's Fear Scale: The Children's Fear Scale (CFS) is used to measure the anxiety or fear level of the children. The one-item scale consists of a row of five sex neutral faces ranging from a no fear (neutral) face on the far left to a face showing extreme fear on the far right. Thus, the scale is 1-5 with 1 being least fear and 5 being greatest fear and anxiety.

Secondary Outcomes

  • Parental Anxiety(Up to 24 hours following procedure)

Study Sites (1)

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