Clinical trial · Interventional
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): enrollment closed due to lack of funding
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anxiety | — | UNRESOLVED | — |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Depression | — | UNRESOLVED | — |
| Sickle Cell Disease | — | UNRESOLVED | — |
| Virtual Reality | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Relaxation response and virtual reality (VR) session | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- VR intervention session
- description
- 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.
- interventionNames
- Device: Relaxation response and virtual reality (VR) session
Primary outcomes (1)
- measure
- Feasibility of VR Session as Measured by Patient Satisfaction Survey.
- timeFrame
- Day 1
- description
- 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'.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 8 Years
Show eligibility criteria text
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
References
Publications (3)
- BACKGROUNDChow 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. PMID 26476281
- BACKGROUNDJonassaint 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. PMID 25831427
- BACKGROUNDShah 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. PMID 24512633