Sickle Cell DiseaseNCT03387033
Role of Virtual Reality (VR) in Patients With Sickle Cell Disease (SCD)
A study testing Relaxation response and virtual reality (VR) session in people with Sickle Cell Disease and Virtual Reality, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sickle Cell Disease, Virtual Reality, Anxiety
- What is being tested?
- Relaxation response and virtual reality (VR) session
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2018to 25 Apr 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients <8 years old
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Role of Virtual Reality (VR) in Decreasing Pain and Anxiety 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 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.
Read the 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.
- Conditions
- Sickle Cell Disease, Virtual Reality, Anxiety, Depression, Cancer
- Being tested
- Relaxation response and virtual reality (VR) session
- Medical subject headings
- Anemia, Sickle Cell, Anxiety Disorders, Depression, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relaxation response and virtual reality (VR) sessionDevice
Also called NeuTab VR Headset, Mindfulness, Deep breathing, Dynamic Virtual Viewer
A 10-minute relaxation response (mindfulness and deep breathing) followed by 10-minute immersive VR session.
| Study group | Role | What they receive |
|---|---|---|
| VR intervention session | Experimental | 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. Receives: Device: Relaxation response and virtual reality (VR) session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of VR Session as Measured by Patient Satisfaction Survey.
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'.
Measured: Day 1
Secondary outcomes (3)
Change in Pain Score
Change in pain score as measured by visual analog pain score (0-10), where 0 = no pain and 10 = worst pain.
Measured: Baseline, up to 30 mins
Change in Anxiety-related Symptoms as Measured by Generalized Anxiety Disorder-7 (GAD-7) Score
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.
Measured: Baseline, up to 30 mins
Change in Depressive Symptoms as Measured by Patient Health Questionnaire-9 (PHQ-9) Score
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.
Measured: Baseline, up to 30 mins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2017
- Study start5 Feb 2018
- Primary completion25 Apr 2019
- Study completion25 Apr 2019
Why it stopped: enrollment closed due to lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nirmish Shah, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03387033
- Sponsor's protocol ID
- Pro00082388
- Status last verified
- Feb 2021
- First submitted
- 14 Jun 2017
- Last updated
- 1 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Currently have collaborators at Pitt interested and may expand study pending feasibility and pilot study results.
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.
PubMed 26476281Jonassaint 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.
PubMed 25831427Shah 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.
PubMed 24512633
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Virtual Reality (VR) in Decreasing Pain and Anxiety in Patients With Sickle Cell Disease (SCD)
- ClinicalTrials.gov ID
- NCT03387033
- Acronym / sponsor ID
- Pro00082388
- Conditions
- Sickle Cell Disease, Virtual Reality, Anxiety, Depression, Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: enrollment closed due to lack of funding
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 5 Feb 2018 (actual)
- Primary completion
- 25 Apr 2019 (actual)
- Study completion
- 25 Apr 2019 (actual)
- First posted
- 29 Dec 2017 (actual)
- Results
- Posted 1 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VR intervention session | Experimental | Device: Relaxation response and virtual reality (VR) sessionThe 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. |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Patients <8 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Relaxation response and virtual reality (VR) sessionAlso: NeuTab VR Headset, Mindfulness, Deep breathing, Dynamic Virtual ViewerA 10-minute relaxation response (mindfulness and deep breathing) followed by 10-minute immersive VR session. | Device | VR intervention session |
Primary outcome
Feasibility of VR Session as Measured by Patient Satisfaction Survey.
Time frame: Day 1
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'.
3 secondary outcomes
Change in Pain Score
Time frame: Baseline, up to 30 mins
Change in Anxiety-related Symptoms as Measured by Generalized Anxiety Disorder-7 (GAD-7) Score
Time frame: Baseline, up to 30 mins
Change in Depressive Symptoms as Measured by Patient Health Questionnaire-9 (PHQ-9) Score
Time frame: Baseline, up to 30 mins
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26476281Chow 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.
- Background: PubMed 25831427Jonassaint 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.
- Background: PubMed 24512633Shah 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.
- Individual participant dataSharing planned: Undecided. Currently have collaborators at Pitt interested and may expand study pending feasibility and pilot study results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nirmish Shah, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Relaxation response and virtual reality (VR) session in people with Sickle Cell Disease and Virtual Reality, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of VR Session as Measured by Patient Satisfaction Survey. (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03387033, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2021.