- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03387033
Role of Virtual Reality (VR) in Patients With Sickle Cell Disease (SCD)
Role of Virtual Reality (VR) in Decreasing Pain and Anxiety in Patients With Sickle Cell Disease (SCD)
Study Overview
Status
Conditions
Intervention / Treatment
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) 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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke University Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / 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.
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A 10-minute relaxation response (mindfulness and deep breathing) followed by 10-minute immersive VR session.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility of VR Session as Measured by Patient Satisfaction Survey.
Time Frame: Day 1
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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'.
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Day 1
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Pain Score
Time Frame: Baseline, up to 30 mins
|
Change in pain score as measured by visual analog pain score (0-10), where 0 = no pain and 10 = worst pain.
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Baseline, up to 30 mins
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Change in Anxiety-related Symptoms as Measured by Generalized Anxiety Disorder-7 (GAD-7) Score
Time Frame: Baseline, up to 30 mins
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GAD-7 total score for the seven items ranges from 0 to 21, calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of "not at all," "several days," "more than half the days," and "nearly every day."
A total score of 0-4 = minimal anxiety, 5-9 = mild anxiety, 10-14 = moderate anxiety, 15-21 = severe anxiety.
A negative score change indicates a decrease in anxiety symptoms and a positive score change indicates an increase in anxiety symptoms.
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Baseline, up to 30 mins
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Change in Depressive Symptoms as Measured by Patient Health Questionnaire-9 (PHQ-9) Score
Time Frame: Baseline, up to 30 mins
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The PHQ-9 has a total range of 0-27, where 0 = No depression, 1-4 = Minimal depression, 5-9 = Mild depression, 10-14 = Moderate depression, 15-19 = Moderately severe depression, 20-27 = Severe depression.
A negative score change indicates a decrease in depressive symptoms and a positive score change indicates an increase in depressive symptoms.
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Baseline, up to 30 mins
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Chow CH, Van Lieshout RJ, Schmidt LA, Dobson KG, Buckley N. Systematic Review: Audiovisual Interventions for Reducing Preoperative Anxiety in Children Undergoing Elective Surgery. J Pediatr Psychol. 2016 Mar;41(2):182-203. doi: 10.1093/jpepsy/jsv094. Epub 2015 Oct 17.
- Jonassaint CR, Shah N, Jonassaint J, De Castro L. Usability and Feasibility of an mHealth Intervention for Monitoring and Managing Pain Symptoms in Sickle Cell Disease: The Sickle Cell Disease Mobile Application to Record Symptoms via Technology (SMART). Hemoglobin. 2015;39(3):162-8. doi: 10.3109/03630269.2015.1025141. Epub 2015 Apr 1.
- Shah N, Jonassaint J, De Castro L. Patients welcome the Sickle Cell Disease Mobile Application to Record Symptoms via Technology (SMART). Hemoglobin. 2014;38(2):99-103. doi: 10.3109/03630269.2014.880716. Epub 2014 Feb 10.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00082388
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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