Ignite Creation Date:
2024-05-06 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06184126
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-08
First Post:
2023-12-04
Brief Title:
Virtual Reality Devices as an Adjunct to Usual Care for Patients With Sickle Cell Disease Experiencing Vaso-Occlusive Crises
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Pilot Study to Investigate the Use of Virtual Reality Devices as an Adjunct to Usual Care for Patients With Sickle Cell Disease Experiencing Vaso-Occlusive Crises
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to evaluate the use of virtual reality as an adjunct to standard care for patients with sickle cell disease experiencing vaso-occlusive crises
Detailed Description:
A prospective non-blinded non-randomized trial will be conducted at the Adult Emergency Department at the University of Maryland Medical Center and Adult Urgent Care Center which is managed by the Department of Emergency Medicine located in Baltimore Maryland
Patients meeting eligibility criteria and who have signed the research informed consent will be enrolled in this study Subject data collected will include demographic information symptoms of the current illness and physical exam findings
Upon enrollment into the study a study team member will interview the patient to collect data needed to complete the Case Report Form Patients assigned to one of the two virtual reality study groups will be directed by research coordinators who can help with equipment as needed throughout the session The virtual reality device will be limited to a maximum of 2 hours of use Assessments will be made at 4 different timepoints 1 Immediately before the intervention 2 at the 1-hour mark of the intervention 3 immediately after the intervention and 4 1 hour after the intervention During these assessments patients will rate their pain intensity using a 0-10 numerical scale Additionally at each assessment patients will be asked to state the change in pain that has taken place since the last measurement This measurement will be performed without informing the patient of their previously recorded pain scores
Data will also be recorded regarding the patients 1 comfort of the device 2 disposition discharged home vs observationadmission status 3 total length of treatment time in the ED measured as time to initiation of any treatment to the time of final disposition and 4 total amount of opioids administered while under the care of the emergency department clinicians converted into morphine milligram equivalents Each patient will complete a questionnaire at the conclusion of the session regarding their perceived impact of the intervention ease of use and likelihood to reuse the intervention
Patients meeting eligibility criteria and who have signed the research informed consent will be enrolled in this study Subject data collected will include demographic information symptoms of the current illness and physical exam findings
Upon enrollment into the study a study team member will interview the patient to collect data needed to complete the Case Report Form Patients assigned to one of the two virtual reality study groups will be directed by research coordinators who can help with equipment as needed throughout the session The virtual reality device will be limited to a maximum of 2 hours of use Assessments will be made at 4 different timepoints 1 Immediately before the intervention 2 at the 1-hour mark of the intervention 3 immediately after the intervention and 4 1 hour after the intervention During these assessments patients will rate their pain intensity using a 0-10 numerical scale Additionally at each assessment patients will be asked to state the change in pain that has taken place since the last measurement This measurement will be performed without informing the patient of their previously recorded pain scores
Data will also be recorded regarding the patients 1 comfort of the device 2 disposition discharged home vs observationadmission status 3 total length of treatment time in the ED measured as time to initiation of any treatment to the time of final disposition and 4 total amount of opioids administered while under the care of the emergency department clinicians converted into morphine milligram equivalents Each patient will complete a questionnaire at the conclusion of the session regarding their perceived impact of the intervention ease of use and likelihood to reuse the intervention
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None