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
• Interventions: Behavioral: Control; Device: Virtual Reality (VR)

• 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

Study Timeline

• Study Start: 2021-12-08
• Study First Submitted: 2023-01-23
• Study First Submitted QC: 2023-01-23
• Primary Completion: 2023-01-25
• Study Completion: 2023-01-25
• Study First Posted: 2023-02-01
• Results First Submitted: 2024-01-25
• Status Verified: 2024-03
• Results First Submitted QC: 2024-03-01
• Last Update Submitted: 2024-03-01
• Results First Posted: 2024-03-27
• Last Update Posted: 2024-03-27

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

Arm && Interventions

Group	Intervention	Description
Control	Control	Standard comfort given
Virtual Reality (VR)	Virtual Reality (VR)	-

Primary Outcome Measures

Name	Time	Method
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 Score	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)	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

Name	Time	Method
Parental Anxiety	Up 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