A Study to Evaluate the Safety and Tolerability of Virtual Reality to Treat Gastroparesis
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|ClinicalTrials.gov Identifier: NCT05079568|
Recruitment Status : Recruiting
First Posted : October 15, 2021
Last Update Posted : December 21, 2021
|Condition or disease||Intervention/treatment||Phase|
|Gastroparesis||Device: Oculus Go VR headset Device: Sham Oculus Go VR headset||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||double blind, randomized.|
|Official Title:||"A Pilot Study to Assess the Safety, Tolerability and Efficacy of Virtual Reality for the Treatment of Gastroparesis"|
|Actual Study Start Date :||October 1, 2021|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2022|
Experimental: Active VR Group
Subjects will be provided an Oculus Go VR headset pre-loaded with a "menu" of virtual reality programs which have been designed specifically to treat both acute and chronic pain. Subjects are required to use the VR headset at home four times daily, prior to breakfast, lunch, dinner, and bedtime. Each session will last approximately 15 minutes.
Device: Oculus Go VR headset
Virtual reality programs consisting of interactive games, meditation and deep breathing exercises, and passive virtual reality experiences designed to facilitate relaxation.
Sham Comparator: Sham VR Group
Subjects will be provided an Oculus Go VR headset pre-loaded two-dimensional nature video. Subjects are required to use the VR headset at home four times daily, prior to breakfast, lunch, dinner, and bedtime. Each session will last approximately 15 minutes.
Device: Sham Oculus Go VR headset
Virtual reality program with two-dimensional nature video
- Patient-reported adverse events [ Time Frame: 4 weeks ]Number of patient-reported adverse events assessed using standardized daily patient-reported adverse event questionnaires
- Changes in global gastroparesis symptom scores [ Time Frame: Baseline, 4 weeks ]Measured by the self-reported GCSI (Gastroparesis Cardinal Symptom Index-daily diary); consisting of questions about severity of symptoms experienced during the past 24 hours on a scale of none, mild, moderate, severe, and very severe.
- Changes in gastrointestinal disorder symptoms [ Time Frame: Baseline, 4 weeks ]Measured using the Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index (PAGI-SYM) questionnaire; consisting of questions about severity of symptoms related to gastrointestinal problem during the past 2 weeks on a scale of 0=note to 5=very severe.
- Changes in individual scores for nausea [ Time Frame: Baseline, 4 weeks ]Measured using Visual Analogue Scale (VAS) where subject place a X on a scale to show how much nausea they had today; scale is 0%=no nausea, 100%=worse nausea ever.
- Changes in abdominal pain [ Time Frame: Baseline, 4 weeks ]Measured using a Numeric Pain Rating Scale (NRS) where subject place a X on a scale to show how much abdominal pain they had today; scale is 0% no abdominal pain, 100% worse abdominal pain ever.
- Changes in bloating [ Time Frame: Baseline, 4 weeks ]Measured using the validated Mayo Bloating Questionnaire to assess subject symptoms of gastroparesis
- Change in work productivity [ Time Frame: Baseline, 4 weeks ]Measured using the validated WPAI (work productivity activity index) to assess subject ability to work and perform regular activities
- Change in Quality of life [ Time Frame: Baseline, 4 weeks ]Measured using the self-reported Short-Form 12 questionnaire; health survey to assess subject views about their health
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05079568
|United States, Florida|
|Mayo Clinic in Florida||Recruiting|
|Jacksonville, Florida, United States, 32224|
|Contact: brian lacy, phd, md 904-650-2000 firstname.lastname@example.org|
|Principal Investigator: Brian Lacy, MD|
|Sub-Investigator: David Cnagemi, MD|
|Jacksonville, Florida, United States, 32224|
|Contact: Brian Lacy, phd, md 904-650-2000 email@example.com|
|Contact: david cangemi, md|
|Principal Investigator:||Brian Lacy, MD||Mayo Clinic|