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

• Sponsor: University of Michigan (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05708586
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 35.8
• Patients Per Site Per Month: 2.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anxiety; Pain	Behavioral: Control; Device: Virtual Reality (VR)	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Virtual Reality Decreases Child Anxiety and Pain as Well as Caregiver Anxiety and Pain Perception During Orthopaedic Clinic Office Procedures
• Actual Study Start Date: Dec 8, 2021
• Anticipated Primary Completion Date: Dec 1, 2024
• Anticipated Study Completion Date: Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Control Standard comfort given	Behavioral: Control; This is the control condition and anxiety is addressed in a standard way of having the care taker calm the child during the intervention.
Experimental: Virtual Reality (VR)	Device: Virtual Reality (VR); The child who is undergoing a procedure uses VR as a distraction during the intervention

Outcome Measures

Primary Outcome Measures

1. Child pain score [Up to 24 hours following procedure]

   Assessed by Wrong-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.

2. 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 for state and 20 to 60 for trait with 60 being the higher (more or worse) anxiety on self-assessment.

3. 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.

Secondary Outcome Measures

1. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 4 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Undergoing cast removal, pin removal, or suture removal in study affiliated clinic

Exclusion Criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Michigan	Ann Arbor	Michigan	United States	48109

Sponsors and Collaborators

• University of Michigan

Investigators

• Study Chair: Noelle Whyte, MD, University of Michigan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Noelle Whyte, Clinical Assistant Professor, University of Michigan
• ClinicalTrials.gov Identifier: NCT05708586
• Other Study ID Numbers: HUM00197192
• First Posted: Feb 1, 2023
• Last Update Posted: Feb 1, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Noelle Whyte, Clinical Assistant Professor, University of Michigan: Virtual reality
• Additional relevant MeSH terms: Anxiety Disorders

Study Results

No Results Posted as of Feb 1, 2023