This clinical trial compares the use of virtual reality (VR) headsets to standard care for reducing pain and anxiety during (peri) and after (post) procedure for patients undergoing bone marrow biopsy and/or aspiration. Bone marrow biopsy is a critical diagnostic procedure but is often associated with significant anticipatory anxiety, procedural pain and post-procedural discomfort. VR headsets can be effective tools for reducing anxiety and enhancing relaxation. VR allows users to engage in calming environments and mindfulness practices contributing to improved mental well-being. Using a VR headset may be more effective in reducing pain and anxiety in the peri and post procedure period, versus standard care, for patients undergoing bone marrow biopsy and/or aspiration.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07203534.
Locations matching your search criteria
United States
North Carolina
Charlotte
Carolinas Medical Center/Levine Cancer InstituteStatus: Active
Contact: Cindy Varga
Phone: 980-442-4363
PRIMARY OBJECTIVE:
I. To evaluate whether VR headsets impact immediate post procedural pain scores in adult patients (age ≥ 18) undergoing bone marrow biopsy and/or bone marrow aspiration in the Hematology/Oncology outpatient clinic compared to patients who received standard of care.
SECONDARY OBJECTIVES:
I. To evaluate whether VR headsets impact post procedural discomfort 24 hours (-6 hours [hrs]/+12 hrs) after the procedure compared to patients who received standard of care.
II. To evaluate whether VR headsets impact anxiety scores in adult patients (age ≥ 18) undergoing bone marrow biopsy and/or bone marrow aspiration in the hematology/oncology outpatient clinic compared to patients who received standard of care.
III. To evaluate whether VR headsets improve patient likelihood to undergo future bone marrow biopsies if clinically recommended compared to patients who received standard of care.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients are fitted for the VR headset and select a calming virtual environment to view during the procedure. Patients then receive routine site specific lidocaine and undergo standard of care bone marrow biopsy and/or aspiration.
ARM II: Patients receive routine site specific lidocaine and undergo standard of care bone marrow biopsy and/or aspiration.
After completion of study treatment, patients are followed up at 24 hours.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationWake Forest University Health Sciences
Principal InvestigatorCindy Varga
