Evidence map›Paper›PMID 34982018›Full record

Trial reportThe Cleft palate-craniofacial journal : official publication of the American Cleft Palate-Craniofacial Association2023

The Cleft Lip Education with Augmented Reality (CLEAR) VR Phase 2 Trial: A Pilot Randomized Crossover Trial of a Novel Patient Information Leaflet.

Steven John Lo, Paul Chapman, David Young, David Drake, Mark Devlin, Craig Russell

Abstract readRandomized Controlled TrialClinical Trial, Phase II
In one paragraph

Trial report in The Cleft palate-craniofacial journal : official publication of the American Cleft Palate-Craniofacial Association, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. Review
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Steven John LoCanniesburn Regional Plastic Surgery and Burns Unit, Glasgow, UK.ORCID 0000-0003-1503-1056
Paul Chapman3517The Glasgow School of Art, Glasgow, UK.ORCID 0000-0002-6390-5558
David Young3527University of Strathclyde, Glasgow, UK.
David DrakeNational Cleft Service, 59842The Royal Hospital for Children, Glasgow, UK.
Mark DevlinNational Cleft Service, 59842The Royal Hospital for Children, Glasgow, UK.
Craig RussellNational Cleft Service, 59842The Royal Hospital for Children, Glasgow, UK.

Funding

Chief Scientist Office CGA/19/71
6 · The paper itself

Abstract

backgroundThe 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.

methodsParticipants 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.

results12 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,

conclusionsThe 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.

Indexed as

Augmented RealityCleft LipCleft PalateVirtual RealityChildCross-Over StudiesHumansPilot Projectsaugmented realitycleft lippatient education handoutpatient information leafletreconstructive surgery

Identifiers

PMID34982018
PMCPMC9850392

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.