Last reviewed · How we verify
NCT04107558: SMARTHY
Healthy Volunteer Undergoing Painful Stimuli With and Without Hypnosis and Virtual Reality
NA trial testing Virtual Reality in Digital Sedation in 60 participants. Completed in 30 August 2022.
21 January 2020
Quick facts
| Lead sponsor | Oncomfort |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | other |
| Enrollment | 60 |
| Start date | 2 September 2019 |
| Primary completion | 21 January 2020 |
| Estimated completion | 30 August 2022 |
| Sites | 1 location across Belgium |
Drugs / interventions tested
- Virtual Reality
Conditions studied
- Digital Sedation — all drugs for Digital Sedation →
Sponsor
Oncomfort
Who can join
Adults 18 to 70, any sex, with Digital Sedation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The main purposes of this study are as follows: Compare the effect of painful stimuli with and without Hypnosis and Virtual Reality (HVR) on healthy volunteers. * Use of sensors and captors to monitor physiological and neurophysiological changes by painful stimulus * Monitor level of pain and anxiety with and without HVR * Monitor level of unpleasantness of the pain with and without HVR * Monitor level of Anxiety, Absorption, Dissociation, Satisfaction and Comfort with and without HVR
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04107558
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Virtual Reality
Trials testing the same drug.
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- NCT07512999 — The Effect of Using Nature Sounds and Virtual Reality During the Non-Stress Test · NA · not yet recruiting
- NCT07520253 — Effect of Virtual Reality on Cortical Reorganization and Upper Extremity Functional Recovery in Patients With Subacute S · NA · not yet recruiting
- NCT07462039 — Effect of Virtual Reality on Pain and Anxiety During Pap Smear Testing · NA · not yet recruiting
- NCT07400874 — Use of Acupressure, Aromatherapy, and Virtual Reality for Children in During Blood Collection Procedures · NA · not yet recruiting
Other Oncomfort trials
Trials by the same sponsor.
- NCT04379882 — Feasibility Study Evaluating the Silva Module During the Anaesthesiology Consultation Before an Elective Surgery · NA · withdrawn
- NCT04465383 — Digital Sedation: Virtual Reality Hypnosis During Colonoscopy · NA · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04107558 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Oncomfort
- Last refreshed: 30 September 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04107558.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing