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

University of Michigan66 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Anxiety Pain

Interventions

ControlBEHAVIORAL

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

Virtual Reality (VR)DEVICE

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

Eligibility

Sex: ALLMin age: 4 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Michigan

Ann Arbor, Michigan, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: Up to 24 hours following procedure

Secondary Outcomes

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).

Time frame: Up to 24 hours following procedure

Data from ClinicalTrials.gov

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