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NCT04307446 · ClinicalTrials.gov registry record · NA
Immersive Virtual Reality and Chronic Back Pain
A NA study, sponsored by Tufts University.
- Completed
- Registry status
- NA
- Development phase
- 23
- Enrollment target
NCT04307446 is a NA study that has completed, run by Tufts University. The registered enrollment target is 23 participants.
The verdict
NCT04307446, a NA study, has completed, sponsored by Tufts University.
- COMPLETED
- Registry status
- NA
- Development phase
- 23 participants
- Enrollment target
Study Summary
In the proposed project the investigators will evaluate the feasibility of Immersive Virtual Reality (IVR) and assess the initial effects of IVR on symptoms, affect, and tolerance to cutaneous stimuli. In this single-arm trial, the investigators will recruit 20 adults with CBP. Prior to their IVR experience, subjects will complete multiday baseline assessments using ecological momentary assessment (EMA) methodology to establish typical levels of symptoms and affect. Afterward, in a single experimental session, they will participate in two counterbalanced IVR sessions: one 10-minute and one 20-minute. Immediately after each session the investigators will measure current symptoms and affect using valid and reliable self-report questionnaires, and we will measure changes in tolerance to cutaneous stimuli using quantitative sensory testing. We will measure symptoms and affect for 72 hours after the experimental session using EMA to determine if there is a carryover. At the completion of this study, we will continue to work with stakeholders to develop clinically relevant IVR interventions for people with CBP.
Interventions
- DEVICE Immersive Virtual Reality
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2021-05-01 |
| Est. Completion | 2023-05-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04307446
The ClinicalTrials.gov registry entry for NCT04307446 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tufts University, which has 163 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Immersive Virtual Reality is the first listed.
NCT04307446 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04307446 about?
NCT04307446 is a clinical study titled "Immersive Virtual Reality and Chronic Back Pain". In the proposed project the investigators will evaluate the feasibility of Immersive Virtual Reality (IVR) and assess the initial effects of IVR on symptoms, affect, and tolerance to cutaneous stimuli. In this single-arm trial, the investigators will recruit 20 adults with CBP. Prior to their IVR ex...
What is the current status of trial NCT04307446?
This trial is currently completed. It is a NA study. The enrollment target is 23 participants. The study started on 2021-05-01. Estimated completion is 2023-05-31.
What interventions are being tested in trial NCT04307446?
The interventions under investigation include: Immersive Virtual Reality (DEVICE).
Who is sponsoring clinical trial NCT04307446?
This trial is sponsored by Tufts University, which has 163 total clinical trials registered on ClinicalTrials.gov.
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