Evidence map›Paper›PMID 30702436›Full record

ArticleJMIR mental health2019

Recommendations for Methodology of Virtual Reality Clinical Trials in Health Care by an International Working Group: Iterative Study.

Brandon Birckhead, Carine Khalil, Xiaoyu Liu, Samuel Conovitz, Albert Rizzo, Itai Danovitch, Kim Bullock, Brennan Spiegel

6 registry-linked trialsAbstract read
In one paragraph

Article in JMIR mental health, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 6 registered trials, which are not on this map. Cited by 190 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
190citing papers in PubMed, 7 pooled it
–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.

NCT04429945 nacompletednot on this mapstarted 2021, after this paper: background citation

Immersive Virtual Reality to Improve Outcomes in Patients With Stroke: A Pilot Study

TypeinterventionalSponsorVA Office of Research and DevelopmentRan2021 to 2022Enrolled10ConditionsStrokeArmsVirtual Reality
NCT05265182 nacompletednot on this mapstarted 2022, after this paper: background citation

Developing an Immersive Gamification Technology System (ImGTS) for the Management of Patients With Behavioral and Psychological Symptoms of Dementia (Phase 1 Trial)

TypeinterventionalSponsorAugmented eXperience E-health LaboratoryRan2022 to 2022Enrolled30ConditionsDementia AlzheimersArmsvirtual reality
NCT05299905 nacompletednot on this mapstarted 2022, after this paper: background citation

Developing Immersive Gamification Technology System (ImGTS) for Rehabilitation Management of Pediatric Patients With Cerebral Palsy and With Mobility Limitations (Phase 1 Trial)

TypeinterventionalSponsorAugmented eXperience E-health LaboratoryRan2022 to 2022Enrolled30ConditionsCerebral PalsyArmsVirtual reality using Semi-CAVE, Virtual reality using the HMD
NCT07329764 nanot yet recruitingnot on this mapstarted 2025, after this paper: background citation

Effectiveness of a Virtual Reality Intervention on Pain, Anxiety, and Satisfaction in Laboring Women

TypeinterventionalSponsorWan-Lin PanRan2025 to 2026Enrolled92ConditionsRelieve Pain, Anxiety, Childbirth ExperienceArmsVirtual Reality
NCT07394231 nacompletednot on this mapstarted 2024, after this paper: background citation

Exploring Innovative Strategies to Enhance Eye-Hand Coordination and Cognitive Functions Through Drone Catching Exercise.

TypeinterventionalSponsorNational Cheng-Kung University HospitalRan2024 to 2024Enrolled38ConditionsHealthy AdultArmsReal Object-Based Catching System, Virtual Object-Based Catching System
NCT07760571 nacompletednot on this mapstarted 2026, after this paper: background citation

Screen-delivered Augmented-reality Preparation and Anxiety Before Pediatric Adenotonsillectomy in China: a Prospective Non-randomized Controlled Study

TypeinterventionalSponsorCentral South UniversityRan2026 to 2026Enrolled100ConditionsTonsillectomy, Preoperative Care, AnxietyArmsScreen-delivered augmented-reality group, Usual Care Group
3 · Its place in the literature

Who cites it

190 citing papers in PubMed, 7 syntheses or guidelines pooled it.

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  14. 'Such a lot of bother': Qualitative results of a home trial of a wearable electronic vision enhancement system for people with age-related macular degeneration.Ophthalmic & physiological optics : the journal of the British College of Ophthalmic Opticians (Optometrists) · 2025
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  16. The Cleft Lip Education with Augmented Reality (CLEAR) VR Phase 2 Trial: A Pilot Randomized Crossover Trial of a Novel Patient Information Leaflet.The Cleft palate-craniofacial journal : official publication of the American Cleft Palate-Craniofacial Association · 2023
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130 more citing papers are in PubMed but not listed here.

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

8 authors.

Brandon BirckheadDivision of Health Services Research, Department of Medicine, Cedars-Sinai Health System, Los Angeles, CA, United States.ORCID http://orcid.org/0000-0002-5822-7318
Carine KhalilDivision of Health Services Research, Department of Medicine, Cedars-Sinai Health System, Los Angeles, CA, United States.ORCID http://orcid.org/0000-0001-5071-0500
Xiaoyu LiuDivision of Health Services Research, Department of Medicine, Cedars-Sinai Health System, Los Angeles, CA, United States.ORCID http://orcid.org/0000-0003-4628-980X
Samuel ConovitzDivision of Health Services Research, Department of Medicine, Cedars-Sinai Health System, Los Angeles, CA, United States.ORCID http://orcid.org/0000-0002-5192-046X
Albert RizzoInstitute for Creative Technologies, University of Southern California, Los Angeles, CA, United States.ORCID http://orcid.org/0000-0003-2647-7731
Itai DanovitchDepartment of Psychiatry, Cedars-Sinai Health System, Los Angeles, CA, United States.ORCID http://orcid.org/0000-0001-9580-6450
Kim BullockDepartment of Psychiatry, Stanford University School of Medicine, Palo Alto, CA, United States.ORCID http://orcid.org/0000-0003-1214-1356
Brennan SpiegelDivision of Health Services Research, Department of Medicine, Cedars-Sinai Health System, Los Angeles, CA, United States.ORCID http://orcid.org/0000-0002-4608-6896

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTherapeutic virtual reality (VR) has emerged as an efficacious treatment modality for a wide range of health conditions. However, despite encouraging outcomes from early stage research, a consensus for the best way to develop and evaluate VR treatments within a scientific framework is needed.

objectiveWe aimed to develop a methodological framework with input from an international working group in order to guide the design, implementation, analysis, interpretation, and communication of trials that develop and test VR treatments.

methodsA group of 21 international experts was recruited based on their contributions to the VR literature. The resulting Virtual Reality Clinical Outcomes Research Experts held iterative meetings to seek consensus on best practices for the development and testing of VR treatments.

resultsThe interactions were transcribed, and key themes were identified to develop a scientific framework in order to support best practices in methodology of clinical VR trials. Using the Food and Drug Administration Phase I-III pharmacotherapy model as guidance, a framework emerged to support three phases of VR clinical study designs-VR1, VR2, and VR3. VR1 studies focus on content development by working with patients and providers through the principles of human-centered design. VR2 trials conduct early testing with a focus on feasibility, acceptability, tolerability, and initial clinical efficacy. VR3 trials are randomized, controlled studies that evaluate efficacy against a control condition. Best practice recommendations for each trial were provided.

conclusionsPatients, providers, payers, and regulators should consider this best practice framework when assessing the validity of VR treatments.

Indexed as

clinical trialsconsensusvirtual reality

Identifiers

PMID30702436
PMCPMC6374734

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

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.