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

NCT03387033 | Terminated Results FDA Device

• 1 other identifier: Pro00082388
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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

Sickle Cell Disease; Virtual Reality; Anxiety; Depression; Cancer

Outcome Measures

Primary Outcomes (1)

• 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'.

  Day 1

Secondary Outcomes (3)

• Change in Pain Score

  Baseline, up to 30 mins

• Change in Anxiety-related Symptoms as Measured by Generalized Anxiety Disorder-7 (GAD-7) Score

  Baseline, up to 30 mins

• Change in Depressive Symptoms as Measured by Patient Health Questionnaire-9 (PHQ-9) Score

  Baseline, up to 30 mins

Study Arms (1)

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.

Device: Relaxation response and virtual reality (VR) session

Interventions

Relaxation response and virtual reality (VR) session DEVICE

A 10-minute relaxation response (mindfulness and deep breathing) followed by 10-minute immersive VR session.

Also known as: NeuTab VR Headset, Mindfulness, Deep breathing, Dynamic Virtual Viewer

VR intervention session

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients \<8 years old

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (3)

• 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.

  PMID: 26476281 BACKGROUND

• 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.

  PMID: 25831427 BACKGROUND

• 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.

  PMID: 24512633 BACKGROUND

Related Links

• National Center for Health Statistics: Mental Health. CDC

MeSH Terms

Conditions

Anemia, Sickle Cell; Anxiety Disorders; Depression; Neoplasms

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Mental Disorders; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Nirmish Shah, MD
• Organization: Duke University

nirmish.shah@duke.edu

919-668-5178

Study Officials

• Nirmish Shah, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2017
• First Posted: December 29, 2017
• Study Start: February 5, 2018
• Primary Completion: April 25, 2019
• Study Completion: April 25, 2019
• Last Updated: March 1, 2021
• Results First Posted: March 1, 2021

Record last verified: 2021-02

Locations

US (1)