Role of Virtual Reality (VR) in Patients With Sickle Cell Disease (SCD)
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|ClinicalTrials.gov Identifier: NCT03387033|
Recruitment Status : Suspended (Study is on hold pending data analysis)
First Posted : December 29, 2017
Last Update Posted : December 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Sickle Cell Disease Virtual Reality Anxiety Depression Cancer||Device: Relaxation response and virtual reality (VR) session||Not Applicable|
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) and caner. The VR headset (NeuTab VR Virtual Reality Headset, Dynamic Virtual Viewer, or similar device) 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 a second iPhone to play the recording while the other iPhone is used to display the VR session.
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. An 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, Presence Questionnaire, and Patient's Global Impression of Change (PGIC) form. Patients will be asked to fill out pain score and general health questions via the TRU-Pain app. Patients will then be able to ask questions/provide further feedback.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Role of Virtual Reality (VR) in Decreasing Pain and Anxiety in Patients With Sickle Cell Disease (SCD)|
|Actual Study Start Date :||February 5, 2018|
|Estimated Primary Completion Date :||January 31, 2020|
|Estimated Study Completion Date :||January 31, 2020|
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.
- Feasibility of VR session as measured by patient satisfaction survey. [ Time Frame: Up to 6 months ]Measuring feasibility by patient satisfaction with session.
- Change in pain score [ Time Frame: Baseline, up to 30 mins ]Change in pain score as measured by visual analog pain score (0-10).
- Change in anxiety-related symptoms [ Time Frame: Baseline, up to 30 mins ]Change in symptoms of anxiety as measured by GAD-7 score.
- Change in depressive symptoms [ Time Frame: Baseline, up to 30 mins ]Change in symptoms of depression after session as measured by PHQ-9 score.
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
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Nirmish Shah, MD||Duke University|