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NCT03387033 · ClinicalTrials.gov registry record · NA

Role of Virtual Reality (VR) in Patients With Sickle Cell Disease (SCD)

A NA study, sponsored by Duke University.

Terminated
Registry status
NA
Development phase
20
Enrollment target

NCT03387033: Clinical Trial NA study, sponsored by Duke University.

NCT03387033 is a NA study that was terminated before completion, run by Duke University. The registered enrollment target is 20 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03387033, a NA study, was terminated before completion, sponsored by Duke University.

TERMINATED
Registry status
NA
Development phase
20 participants
Enrollment target

Study Summary

Patients with sickle cell disease (SCD) and cancer often have complicated courses while hospitalized and often deal with pain, anxiety and depression. Advances in the field of technology provide potential avenues for innovative and improved care models for our patients. Virtual reality (VR) has been recently utilized to improve anxiety and pain in a variety of patient populations including children undergoing elective surgery and children experiencing intravenous cannulation in the Emergency Department. Patients with SCD and cancer, both adults and children, are a group of patients that can benefit from VR as part of their care. Over the past four years, our team has successfully implemented several self-developed mobile applications ("apps") for our patients, in addition to integrating objective data (heart rate, activity, stress) from wearable activity trackers. The investigators now propose implementing a feasibility study followed by a pilot study and randomized-controlled trial of the use of VR in patients with SCD and cancer. The investigators plan to assess pain and anxiety prior to the session as well as following the session in hospitalized patients and outpatients with SCD and cancer. The sessions will include a ten-minute relaxation response introductory narrative segment (deep breathing and mindfulness) followed by a ten-minute narrated and immersive VR. Heart rate will be tracked using an Apple iWatch for 30 minutes prior to the session, during the session, and following the session. We anticipate VR will not only be a feasible method to provide non-pharmacologic treatment, but will also significantly reduce pain and anxiety.

Primary Outcome

Patient satisfaction with session measured on a Likert-type scale with the following options: Very unsatisfied, unsatisfied, not unsatisfied or satisfied, satisfied, very satisfied. Participants were also asked if they agree with the statement that the 'VR device was helpful'.

Interventions

  • DEVICE Relaxation response and virtual reality (VR) session

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2018-02-05
Est. Completion 2019-04-25
Phase NA
Duke University

1,725 total trials

Why NCT03387033 stopped before completion

NCT03387033 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 1 intervention - of which Relaxation response and virtual reality (VR) session is the first listed.

NCT03387033 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03387033 about?

NCT03387033 is a clinical study titled "Role of Virtual Reality (VR) in Patients With Sickle Cell Disease (SCD)". Patients with sickle cell disease (SCD) and cancer often have complicated courses while hospitalized and often deal with pain, anxiety and depression. Advances in the field of technology provide potential avenues for innovative and improved care models for our patients. Virtual reality (VR) has been...

What is the current status of trial NCT03387033?

This trial is currently terminated. It is a NA study. The enrollment target is 20 participants. The study started on 2018-02-05. Estimated completion is 2019-04-25.

What interventions are being tested in trial NCT03387033?

The interventions under investigation include: Relaxation response and virtual reality (VR) session (DEVICE).

Who is sponsoring clinical trial NCT03387033?

This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03387033's enrollment target sits among peer trials

20 1768th of 2000 higher than 140 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03387033, the US trial registry maintained by the National Library of Medicine. NCT03387033 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.