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

NCT05708586 | Terminated Results FDA Device

• 1 other identifier: HUM00197192
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Pain

Keywords

Virtual reality

Outcome Measures

Primary Outcomes (3)

• Child Pain Score

  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.

  Up to 24 hours following procedure

• Child Anxiety (7 Years Old and Older)

  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.

  Up to 24 hours following procedure

• Child Anxiety (Younger Than 7 Years Old)

  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.

  Up to 24 hours following procedure

Secondary Outcomes (1)

• Parental Anxiety

  Up to 24 hours following procedure

Study Arms (2)

Control

ACTIVE COMPARATOR

Standard comfort given

Behavioral: Control

Virtual Reality (VR)

EXPERIMENTAL

Device: Virtual Reality (VR)

Interventions

Control BEHAVIORAL

This is the control condition and anxiety is addressed in a standard way of having the care taker calm the child during the intervention.

Control

Virtual Reality (VR) DEVICE

The child who is undergoing a procedure uses VR as a distraction during the intervention

Virtual Reality (VR)

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Undergoing cast removal, pin removal, or suture removal in study affiliated clinic
• Less than 17 years old

You may not qualify if:

• History of seizures
• Pregnant, have preexisting binocular vision abnormalities or psychiatric disorders, or suffer from a heart condition or other serious medical condition
• Patients can't have implanted medical devices including cardiac pacemakers, hearing aids and defibrillators
• There is no minimum or maximum age for the Caretakers/Parents.

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Noelle Whyte
• Organization: University of Michigan

whyteno@umich.edu

734 936-5780

Study Officials

• Noelle Whyte, MD

  University of Michigan

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: January 23, 2023
• First Posted: February 1, 2023
• Study Start: December 8, 2021
• Primary Completion: January 25, 2023
• Study Completion: January 25, 2023
• Last Updated: March 27, 2024
• Results First Posted: March 27, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)