Clinical trial · Interventional
Augmented Reality (AR): The Future of "Patient Information Leaflets
NCT04619030CI-TRIAL-00052192unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
This project aims to assess a new type of Augmented Reality Patient Information leaflet, in order to demonstrate that it is a beneficial information resource to patients when facing the diagnosis of sarcoma, breast cancer or to explain difficult concepts such as cleft lip repair. There are no published studies on the use of AR in patient leaflets.
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Cleft Lip and Palate | — | UNRESOLVED | — |
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
| Surgical Flap | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Augmented Reality | Other | — | UNRESOLVED |
| Traditional leaflet | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Augmented Reality Leaflet
- description
- Patient Leaflet with Augmented reality component
- interventionNames
- Other: Augmented Reality
- type
- ACTIVE_COMPARATOR
- label
- Traditional Leaflet
- description
- Traditional leaflet without Augmented Reality component
- interventionNames
- Other: Traditional leaflet
Primary outcomes (1)
- measure
- Mental Effort Rating Scale
- timeFrame
- Single point at day 1 (Patient assesses leaflet once after reading leaflet)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * patients who have undergone reconstructive surgery * patients who are awaiting reconstructive surgery * patients with sarcoma * patients with breast cancer * patients with reconstructive flaps * patients with or parents of patients with cleft lip and palate * Patients with dyslexia will be included Exclusion Criteria: * Cannot speak or read English * Blind/severely visually impaired
References
Publications (1)
- DERIVEDLo SJ, Chapman P, Young D, Drake D, Devlin M, Russell C. The Cleft Lip Education with Augmented Reality (CLEAR) VR Phase 2 Trial: A Pilot Randomized Crossover Trial of a Novel Patient Information Leaflet. Cleft Palate Craniofac J. 2023 Feb;60(2):179-188. doi: 10.1177/10556656211059709. Epub 2022 Jan 4. PMID 34982018