Canniesburn Regional Plastic Surgery and Burns Unit, Glasgow, UK.
3517The Glasgow School of Art, Glasgow, UK.
Cleft Palate Craniofac J. 2023 Feb;60(2):179-188. doi: 10.1177/10556656211059709. Epub 2022 Jan 4.
The Cleft Lip Education with Augmented Reality (CLEAR) project centers around the use of augmented reality (AR) in patient leaflets, as a visual means to overcome the "health literacy" gap. This trial followed Virtual Reality (VR CORE) guidelines for VR Phase 2 (Pilot) trials.
Participants included families of children treated for Cleft Lip and Palate at the Royal Hospital for Children, Glasgow. Interventions were AR leaflet or Traditional Leaflet. Objectives were to calculate sample sizes, assess outcome instruments, trial design, and acceptability to patients. Primary outcome measure was Mental Effort Rating Scale, and secondary outcomes were Patient Satisfaction (Visual Analogue Scale), Usefulness Scale for Patient Information Material (USE) scale, and Instructional Materials Motivation Survey (IMMS). Randomization was by block randomization. The trial was single blinded with assessors blinded to group assignment.
12 Participants were randomized, with crossover design permitting analysis of 12 per group. Primary outcome with Mental Effort Rating Scale indicated higher mental effort with Traditional compared to AR Leaflet (4.75 vs 2.00, = .0003). Secondary outcomes for Satisfaction were Traditional 54.50 versus AR 93.50 ( = .0001); USE scale 49.42 versus 74.08 ( = .0011); and IMMS 112.50 versus 161.75 ( = .0003). Subjective interviews noted overwhelmingly positive patient comments regarding the AR leaflet. Outcome instruments and trial design were acceptable to participants. No harms were recorded.
The CLEAR pilot trial provides early evidence of clinical efficacy of AR leaflets in patient education. It is hoped that this will provide a future paradigm shift in the way patient education is delivered.
CLEAR 项目以增强现实 (AR) 在患者手册中的使用为中心，作为克服“健康素养”差距的视觉手段。该试验遵循虚拟现实 (VR CORE) 第二阶段 (试点) 试验指南。
参与者包括在格拉斯哥皇家儿童医院接受唇腭裂治疗的儿童的家庭。干预措施是 AR 手册或传统手册。目的是计算样本量、评估结果工具、试验设计和患者可接受性。主要结局测量指标是心理努力评分量表，次要结局测量指标是患者满意度（视觉模拟量表）、患者信息材料有用性量表 (USE) 和教学材料动机调查 (IMMS)。采用分组随机化。试验采用单盲法，评估员对分组分配进行盲法。
共有 12 名参与者随机分组，采用交叉设计分析每组 12 名参与者。心理努力评分量表的主要结局表明，与 AR 手册相比，传统手册的心理努力更高（4.75 对 2.00， = .0003）。满意度的次要结局为传统手册 54.50 对 AR 手册 93.50（ = .0001）；USE 量表 49.42 对 74.08（ = .0011）；和 IMMS 112.50 对 161.75（ = .0003）。主观访谈记录了患者对 AR 手册的压倒性积极评价。参与者对结局工具和试验设计表示认可。没有记录到伤害。
CLEAR 试点试验为 AR 手册在患者教育中的临床疗效提供了早期证据。希望这将为未来提供一种全新的患者教育模式。
