Clinical trial · Interventional
Patient Augmented Reality and Vibratory Array Otorhinolaryngology Procedures
Using Augmented Reality With Vibroacoustic Stimulation to Improve the Patient Experience During In-Office Otorhinolaryngology Procedures
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
In-office procedures (IOPs) are a cost-effective, and safe alternative to many operating room procedure, with benefits such as reduced anesthesia risk. One of the major causes of failed in-office procedures or requirement of conversion to the operating room is poor patient tolerance. Vibration and augmented reality (AR) can be used as non-pharmacologic treatment options to treat patient anxiety and pain by using the physiology proposed by the gate-way theory of pain as well as distraction. This study seeks to compare anxiety and pain perception with patient reported survey data, as well as physiologic indicators of stress such as heart rate variability (HRV) within patients undergoing IOPs in a laryngology office with and without vibration and AR treatment.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Laryngeal Neoplasms | Laryngeal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Pain, Acute | — | UNRESOLVED | — |
| Vocal Cord Paralysis | — | UNRESOLVED | — |
| Vocal Fold Polyp | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Augmented reality off | Other | — | UNRESOLVED |
| Augmented Reality on | Other | — | UNRESOLVED |
| Vibroacoustic stimulation off | Other | — | UNRESOLVED |
| Vibroacoustic stimulation on | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- NO_INTERVENTION
- label
- No treatment
- description
- This arm will be the current standard of care
- type
- EXPERIMENTAL
- label
- Vibroacoustic
- description
- This arm will use the vibroacoustic device to provide a mechanical stimulus to the patient as treatment to reduce pain and anxiety. Augmented reality glasses will be worn but will be turned off.
- interventionNames
- Other: Vibroacoustic stimulation on
- Other: Augmented reality off
- type
- EXPERIMENTAL
- label
- Augmented Reality
- description
- This arm will use the augmented reality game to provide a visual stimulus to the patient as treatment to reduce pain and anxiety. Vibroacoustic device will be worn but will be turned off.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients undergoing office-based laryngology procedure performed at home institution. Exclusion Criteria: * None
References
Publications (13)
- BACKGROUNDMcCarthy M. US health-care system faces cost and insurance crises. Rising costs, growing numbers of uninsured, and quality gaps trouble world's most expensive health-care system. Lancet. 2003 Aug 2;362(9381):375. doi: 10.1016/s0140-6736(03)14057-3. No abstract available. PMID 12907006
- BACKGROUNDRice T, Rosenau P, Unruh LY, Barnes AJ, Saltman RB, van Ginneken E. United States of America: health system review. Health Syst Transit. 2013;15(3):1-431. PMID 24025796
- BACKGROUNDHoffer EP. The American Health Care System Is Broken. Part 7: How Can We Fix It? Am J Med. 2019 Dec;132(12):1381-1385. doi: 10.1016/j.amjmed.2019.10.003. Epub 2019 Oct 24. PMID 31668898
- BACKGROUNDYoung S, Shapiro FE, Urman RD. Office-based surgery and patient outcomes. Curr Opin Anaesthesiol. 2018 Dec;31(6):707-712. doi: 10.1097/ACO.0000000000000655. PMID 30148715
- BACKGROUNDSaini AT, Citardi MJ, Yao WC, Luong AU. Office-Based Sinus Surgery. Otolaryngol Clin North Am. 2019 Jun;52(3):473-483. doi: 10.1016/j.otc.2019.02.003. Epub 2019 Mar 22. PMID 30905564
- BACKGROUNDShah PD. Patient Safety and Quality for Office-Based Procedures in Otolaryngology. Otolaryngol Clin North Am. 2019 Feb;52(1):89-102. doi: 10.1016/j.otc.2018.08.015. Epub 2018 Sep 22. PMID 30249445
- BACKGROUNDBraz J, Solorzano C, Wang X, Basbaum AI. Transmitting pain and itch messages: a contemporary view of the spinal cord circuits that generate gate control. Neuron. 2014 May 7;82(3):522-36. doi: 10.1016/j.neuron.2014.01.018. PMID 24811377
- BACKGROUNDTreede RD. Gain control mechanisms in the nociceptive system. Pain. 2016 Jun;157(6):1199-1204. doi: 10.1097/j.pain.0000000000000499.