Back to resultsVirtual Reality Decreases Child Anxiety and Pain as Well as Caregiver Anxiety and Pain Perception During Orthopaedic Clinic Office Procedures
Primary Purpose
Anxiety, Pain
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Control
Virtual Reality (VR)
Sponsored by
About this trial
This is an interventional supportive care trial for Anxiety focused on measuring Virtual reality
Eligibility Criteria
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.
Sites / Locations
- University of Michigan
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control
Virtual Reality (VR)
Arm Description
Standard comfort given
Outcomes
Primary Outcome Measures
Child pain score
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.
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 for state and 20 to 60 for trait with 60 being the higher (more or worse) anxiety on self-assessment.
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.
Secondary Outcome Measures
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).
Full Information
NCT ID
NCT05708586
First Posted
January 23, 2023
Last Updated
September 4, 2023
Sponsor
University of Michigan
1. Study Identification
Unique Protocol Identification Number
NCT05708586
Brief Title
Virtual Reality Decreases Child Anxiety and Pain as Well as Caregiver Anxiety and Pain Perception During Orthopaedic Clinic Office Procedures
Official Title
Virtual Reality Decreases Child Anxiety and Pain as Well as Caregiver Anxiety and Pain Perception During Orthopaedic Clinic Office Procedures
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Terminated
Why Stopped
Preliminary findings showed no significant difference between virtual reality and distraction techniques.
Study Start Date
December 8, 2021 (Actual)
Primary Completion Date
January 25, 2023 (Actual)
Study Completion Date
January 25, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Pain
Keywords
Virtual reality
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Standard comfort given
Arm Title
Virtual Reality (VR)
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
This is the control condition and anxiety is addressed in a standard way of having the care taker calm the child during the intervention.
Intervention Type
Device
Intervention Name(s)
Virtual Reality (VR)
Intervention Description
The child who is undergoing a procedure uses VR as a distraction during the intervention
Primary Outcome Measure Information:
Title
Child pain score
Description
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.
Time Frame
Up to 24 hours following procedure
Title
Child anxiety (7 years old and older)
Description
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.
Time Frame
Up to 24 hours following procedure
Title
Child anxiety (Younger than 7 years old)
Description
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.
Time Frame
Up to 24 hours following procedure
Secondary Outcome Measure Information:
Title
Parental anxiety
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noelle Whyte, MD
Organizational Affiliation
University of Michigan
Official's Role
Study Chair
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Virtual Reality Decreases Child Anxiety and Pain as Well as Caregiver Anxiety and Pain Perception During Orthopaedic Clinic Office Procedures
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