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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05708586
• Other study ID #: HUM00197192
• Status: Terminated
• Phase: N/A
• Start date: December 8, 2021
• Est. completion date: January 25, 2023

Study information

• Verified date: March 2024
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 66
• Est. completion date: January 25, 2023
• Est. primary completion date: January 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years and older

Eligibility

Inclusion Criteria for pediatric patient:

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

• Less than 17 years old

Exclusion Criteria for pediatric patient:

• 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.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Pain

Intervention

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.

Device:
• Virtual Reality (VR)
The child who is undergoing a procedure uses VR as a distraction during the intervention

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Parental Anxiety	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).	Up to 24 hours following procedure