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

Not Applicable
Terminated
Conditions
Pain
Anxiety
Registration Number
NCT05708586
Lead Sponsor
University of Michigan
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
66
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Child Anxiety (7 Years Old and Older)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 ScoreUp 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)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 Outcome Measures
NameTimeMethod
Parental AnxietyUp to 24 hours following procedure

Assessed by State-Trait Anxiety Inventory (STAI): a 20 question inventory where each question is on a Likert scale 1-4. The total range of the inventory is 20-80 with higher scores indicating more anxiety (please note that some questions are reverse coded).

Trial Locations

Locations (1)

University of Michigan

🇺🇸

Ann Arbor, Michigan, United States

University of Michigan
🇺🇸Ann Arbor, Michigan, United States

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