Virtual Reality Clinical Trial
Official title:
Virtual Reality as Distraction Analgesia and Anxiolysis for Pediatric Otolaryngology Procedures
The primary aim of this randomized controlled trial is to determine the efficacy of Virtual Reality in pediatric otolaryngology clinics as distraction analgesia and anxiolysis for patients undergoing otologic procedures.
| Status | Recruiting |
| Enrollment | 100 |
| Est. completion date | December 2024 |
| Est. primary completion date | December 2024 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 7 Years to 17 Years |
| Eligibility | Inclusion Criteria: - Pediatric patients, ages 7-17 years old, undergoing an in-office microscope ear examination with possible debridement/instrumentation by a single fellowship trained neurotologist . Exclusion Criteria: - 1) patients with a history of chronic pain disorders 2) developmental delay including autism spectrum disorders 3) neurologic or seizure disorders 4) visual impairment 5) claustrophobia |
| Country | Name | City | State |
|---|---|---|---|
| United States | Walter Reed National Military Medical Center | Bethesda | Maryland |
| Lead Sponsor | Collaborator |
|---|---|
| Walter Reed National Military Medical Center |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Wong-Baker FACES Pain Scale | during the in clinic procedure | ||
| Primary | Subjective Units of Distress Scale | during the in clinic procedure |
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