An interventional study of Control and Virtual Reality (VR) in Anxiety and Pain, sponsored by University of Michigan. Terminated at 1 site in United States. Open to participants aged 4 Years and older. Per ClinicalTrials.gov, last updated 2024-03-27.
Sponsored by University of Michigan · Not applicable, Interventional, and Supportive care
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.
4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.
This study's enrollment of 66 is below the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →University of Michigan is the lead sponsor of 1,475 studies on the registry; 196 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria for pediatric patient:
There is no minimum or maximum age for the Caretakers/Parents.
Standard comfort given
Behavioral: Control
Device: Virtual Reality (VR)
This is the control condition and anxiety is addressed in a standard way of having the care taker calm the child during the intervention.
The child who is undergoing a procedure uses VR as a distraction during the intervention
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
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
| Milestone | Control | Virtual Reality (VR) |
|---|---|---|
| Started | 28 | 35 |
| Completed | 28 | 35 |
| Not completed | 0 | 0 |
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.
| units on a scale | Control | Virtual Reality (VR) |
|---|---|---|
| Pre-Intervention | .5 (0 to 6) | 1.2 (0 to 4) |
| Post-Intervention | 1.07 (0 to 10) | .97 (0 to 6) |
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.
| units on a scale | Control | Virtual Reality (VR) |
|---|---|---|
| Pre-Intervention | 28.55 (20 to 42) | 32.88 (20 to 46) |
| Post-Intervention | 26.35 (20 to 31) | 27.96 (20 to 47) |
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.
| units on a scale | Control | Virtual Reality (VR) |
|---|---|---|
| Pre-Intervention | 1.375 (0 to 4) | 1.5 (0 to 4) |
| Post-Intervention | .75 (0 to 4) | 0.875 (0 to 4) |
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).
| score on a scale | Control | Virtual Reality (VR) |
|---|---|---|
| Parental Anxiety | 46.61 (34 to 65) | 46.91 (37 to 61) |
Collected over Up to 24 hours. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control | 0/28 (0%) | 0/28 (0%) | 0/28 (0%) |
| Virtual Reality (VR) | 0/35 (0%) | 0/35 (0%) | 0/35 (0%) |
| Age, Customized(Participants) | Control | Virtual Reality (VR) | Total |
|---|---|---|---|
| Age <7 | 8 | 7 | 15 |
| Age >=7 | 20 | 28 | 48 |
| Sex: Female, Male(Participants) | Control | Virtual Reality (VR) | Total |
|---|---|---|---|
| Female | 14 | 16 | 30 |
| Male | 14 | 19 | 33 |
| Race and Ethnicity Not Collected(Participants) | Control | Virtual Reality (VR) | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Control | Virtual Reality (VR) | Total |
|---|---|---|---|
| United States | 28 | 35 | 63 |
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University of Michigan