CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 146 enrolled
Drug / intervention
Intravenous sedation +2 moredrug
Likely dose
Intravenous sedation 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04887285
NCT04887285N/ACompleted
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Can Distraction Substitute for Procedural Sedation and Improve Tolerance in Patients Receiving Epidural Steroid Injection for Pain? A Randomized Controlled Trial

Johns Hopkins University·interventional·Posted May 14, 2021·Updated Dec 2, 2024

In Brief

A clinical study evaluating Virtual reality, Intravenous sedation, and 1 other intervention for Lower Back Pain and Lumbar Radiculopathy. Completed, enrolled 146 participants across 1 site.

Detailed Summary

This study examines the impact of virtual reality compared to sedation (midazolam and/or fentanyl) and no intervention on pain experienced from an epidural steroid injection (ESI). The intervention group (who receive virtual reality as a distraction modality) is compared to a sedation group and a control group.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLower Back Pain, Lumbar Radiculopathy
CountriesUnited States
CollaboratorsUnited States Department of Defense, The Geneva Foundation, Walter Reed National Military Medical Center, United States Naval Medical Center, San Diego, Brigham and Women's Hospital

Timeline

N/ACompletedFinished
20222023202420252026
First PostedMay 14, 2021
Enrollment StartMar 28, 2022
Primary CompletionAug 15, 2023
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 5.1 years ago

Interventions

Virtual realitydevice

Subjects in the virtual reality group will be offered a variety of immersive environments to choose from (mountains, beach, rainforest and temperate forest) in addition to local anesthetic.

Intravenous sedationdrug

Sedation will be administered using low-dose midazolam and/ or fentanyl. We will use a wide range of dosing (1-5 mg for midazolam, up to 150 mcg for fentanyl) to maximize generalizability and account for widespread variability in clinical circumstances, medical practice and patient response (personalized medicine). Sedation will be titrated to effect by a board-certified or eligible anesthesiologist so that patients remain responsive to verbal stimuli.

Standard careother

Patients will receive superficial local anesthetic with 1% lidocaine. Local anesthetic will be administered by the physician performing the procedure titrated to patient comfort.