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

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ClinicalTrials.gov Identifier: NCT03387033
Recruitment Status : Not yet recruiting
First Posted : December 29, 2017
Last Update Posted : December 29, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
Patients with sickle cell disease (SCD) 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, 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. 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. 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. We anticipate VR will not only be a feasible method to provide non-pharmacologic treatment, but will also significantly reduce pain and anxiety.

Condition or disease Intervention/treatment
Sickle Cell Disease Virtual Reality Anxiety Depression Device: Relaxation response and virtual reality (VR) session

Detailed Description:

The investigators will perform a feasibility and pilot study evaluating relaxation response (narration leading through deep-breathing, mindfulness, and other relaxation techniques) followed by VR in patients with sickle cell disease (SCD). The VR headset (NeuTab VR Virtual Reality Headset) used will be compatible with an iPhone purchased by the PI. The VR session will be narrated by Jon Seskevich, RN. Patients will be provided with headphones.

The patients will first be provided a consent form and consented. They will have the opportunity to ask questions prior to and following consent. They will subsequently give a pain score and fill out a GAD-7 (Generalized Anxiety Disorder) and PHQ-9 (Patient Health Questionnaire) form. They will be taught how to use the VR headset. Patients will listen to a recording by Jon Seskevich, RN of a ten-minute relaxation response. The iPhone will then be placed in the VR headset, the recording started, and the headset placed on the patient. The VR scene is available through Provata VR app and has been previously chosen prior to the start of the study. Following this, patients will again give a pain score as well as complete another GAD-7, PHQ-9, feasibility questionnaire, and Patient's Global Impression of Change (PGIC) form. Patients will then be able to ask questions/provide further feedback.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Role of Virtual Reality (VR) in Decreasing Pain and Anxiety in Patients With Sickle Cell Disease (SCD)
Anticipated Study Start Date : January 1, 2018
Estimated Primary Completion Date : July 1, 2018
Estimated Study Completion Date : July 1, 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: VR intervention session
The patients will give a pain score as well as fill out GAD-7 and PHQ-9 scores initially. The VR intervention session consists of relaxation narration WITH Virtual Reality session for 20 minutes while wearing the VR device. They will then be again asked to give a pain score and fill out GAD-7, PHQ-9, and PGIC.
Device: Relaxation response and virtual reality (VR) session
A 10-minute relaxation response (mindfulness and deep breathing) followed by 10-minute immersive VR session.
Other Names:
  • NeuTab VR Headset
  • Mindfulness
  • Deep breathing

Outcome Measures

Primary Outcome Measures :
  1. Feasibility of VR session as measured by patient satisfaction survey. [ Time Frame: Up to 6 months ]
    Measuring feasibility by patient satisfaction with session.

Secondary Outcome Measures :
  1. Change in pain score [ Time Frame: Baseline, up to 30 mins ]
    Change in pain score as measured by visual analog pain score (0-10).

  2. Change in anxiety-related symptoms [ Time Frame: Baseline, up to 30 mins ]
    Change in symptoms of anxiety as measured by GAD-7 score.

  3. Change in depressive symptoms [ Time Frame: Baseline, up to 30 mins ]
    Change in symptoms of depression after session as measured by PHQ-9 score.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • These patients must have a diagnosis of chronic or acute pain (current pain or baseline pain score >0) AND
  • These patients must have anxiety and depressive symptoms as measured by the GAD-7 or PHQ-9 questionnaires

Exclusion Criteria:

  • Patients <8 years old
Contacts and Locations

Information from the National Library of Medicine

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): NCT03387033

Contact: Nirmish Shah, MD 919-620-5300 nirmish.shah@duke.edu
Contact: Amanda Johnson, MD amanda.k.johnson@duke.edu

United States, North Carolina
Duke University Medical Center Not yet recruiting
Durham, North Carolina, United States, 27710
Contact: Nirmish Shah, MD         
Sponsors and Collaborators
Duke University
Principal Investigator: Nirmish Shah, MD Duke University
More Information

Additional Information:
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03387033     History of Changes
Other Study ID Numbers: Pro00082388
First Posted: December 29, 2017    Key Record Dates
Last Update Posted: December 29, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Currently have collaborators at Pitt interested and may expand study pending feasibility and pilot study results.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Hematologic Diseases
Genetic Diseases, Inborn