Using Virtual Reality for Patients With Gastrointestinal Disease

Study Purpose

The primary aim of this study is to evaluate the effect and impact of a technology which creates a virtual reality (VR), personalized representation of a patient's endoscopic findings in comparison our standard practice (SP). Our study will compare the level of knowledge, understanding and satisfaction the patient and family have between those receiving SP and those receiving both SP and VR.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 8 Years - 25 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Patients aged 8-25 years of age who are willing and able to participate - Patients who recently had an endoscopic procedure at Boston Children's Hospital

Exclusion Criteria:

- Patients who are unable to provide consent due to age or developmental status

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03719209
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Boston Children’s Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherOther
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Gastrointestinal Disease, Inflammatory Bowel Diseases
Arms & Interventions

Arms

Placebo Comparator: Standard Practice

Patients and families will be shown images of their endoscopic procedure per standard practice.

Experimental: Virtual Reality

Patients and families will be showed the results of their endoscopic procedure via a virtual reality application called HealthVoyager, in addition to standard practice images.

Interventions

Other: - HealthVoyager

HealthVoyager is a virtual reality application that allows providers to create customized representations for patients and share the results of endoscopic procedures via an interactive platform. The app can show both normal and abnormal endoscopic findings and anatomy. Families will also receive a web link so that they may access the procedure results via the app at home on their smartphone or tablet.

Other: - Standard Practice

Patients and families will receive handouts with printed images of their endoscopic findings, as per standard practice at Boston Children's Hospital.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Boston Children's Hospital, Boston, Massachusetts

Status

Recruiting

Address

Boston Children's Hospital

Boston, Massachusetts, 02115

Site Contact

McKenzie M Leier, BA

mckenzie.leier@childrens.harvard.edu

617-919-4609

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