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Evaluation of Virtual Reality to Save Morphinic in the Treatment of Vaso-occlusive Seizures of Sickle Cell Patients Consulting in the Emergency Room (ReVCVO)

Primary Purpose

Vaso-occlusive Crisis, Sickle Cell Disease

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Virtual Reality
Usual Care
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Vaso-occlusive Crisis focused on measuring Virtual reality, Vaso occlusive seizure, Sickle Cell Disease, Emergency Room, Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥ 18 years
  • sickle cell patient consulting in the emergency room for VOS
  • Signature free and informed consent

Exclusion Criteria:

  • Consultation in the ER for the same reason in the 14 days prior to inclusion (same episode)
  • Emergency room consultation more than 12 times in the previous year
  • Nausea and vomiting at the time of inclusion
  • History of epilepsy
  • A visually impaired or hard of hearing patient
  • Pregnant patient
  • Previous inclusion in the study

Sites / Locations

  • HOPITAL TENON Service des urgences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

INTERVENTION

NO INTERVENTION

Arm Description

Use of virtual reality in the management of sickle cell patients with VOS

Outcomes

Primary Outcome Measures

Total dose of morphine
Total dose of morphine (in milligrams), used in the emergency room after initial titration, meaning the dose administered by PCA and secondary titrations in case of recurrence of painful peak with AVS>7

Secondary Outcome Measures

Feasibility of implementing the scheme
Number of patents included in the protocol vs. number of potentially eligible patients For patients included during the VR period: the number of VR sessions performed, and the duration of these sessions.
Tolerance
Side effects such as headache, nausea, eye pain or dizziness
Acceptability
Patient's willingness to use VR again at future VOS Evaluation of patient satisfaction
Pain Efficiency
Evaluation of AVS before and after the virtual reality session Numbers of painful areas before and after virtual reality

Full Information

First Posted
February 15, 2021
Last Updated
October 15, 2021
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT04756375
Brief Title
Evaluation of Virtual Reality to Save Morphinic in the Treatment of Vaso-occlusive Seizures of Sickle Cell Patients Consulting in the Emergency Room
Acronym
ReVCVO
Official Title
Evaluation of Virtual Reality to Save Morphinic in the Treatment of Vaso-occlusive Seizures of Sickle Cell Patients Consulting in the Emergency Room
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
March 4, 2021 (Actual)
Primary Completion Date
September 2, 2021 (Actual)
Study Completion Date
September 2, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The management of pain in the emergency department is a major issue, especially for sickle cell patients who regularly consult for vaso-occlusive seizure (VOS). The place of virtual reality remains to be defined in a busy environment, in which the permanence of care generates a significant turn over of medical and paramedical personnel. With Its immersive nature, allowing the patient to detach from his immediate environment, wich is often stressful for patients, we can hope that in multimodal management, Virtual Reality (VR) can contribute to a faster reduction in pain with lower doses of morphine, but so far we have no data. Our pilot study aims to assess the effectiveness, feasibility and tolerance of adding virtual reality to the management of VOS in sickle cell patients in the ER.
Detailed Description
It will be a Before-after study: this study will be conducted in 2 phases in the emergency department a period of usual management of sickle cell patients with VOS then a phase during which the device will be used. Each phase will last 3 months; the duration of the periods may be shorter if recruitment targets are met. Patients will be included consecutively. The main objective of the study is to measure the impact of virtual reality on the total dose of morphine administered to the emergency room in the treatment of vaso-occlusive seizures after initial morphine titration. The primary endpoint is the total dose of morphine (in milligrams), used in the emergency room after initial titration, meaning the dose administered by PCA (patient-controlled analgesia) and secondary titrations in the event of a recurrence of painful spikes with analog verbal scale (AVS) >7.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaso-occlusive Crisis, Sickle Cell Disease
Keywords
Virtual reality, Vaso occlusive seizure, Sickle Cell Disease, Emergency Room, Pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
97 (Actual)

8. Arms, Groups, and Interventions

Arm Title
INTERVENTION
Arm Type
Experimental
Arm Description
Use of virtual reality in the management of sickle cell patients with VOS
Arm Title
NO INTERVENTION
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Virtual Reality
Intervention Description
Use of virtual reality in the management of sickle cell patients with VOS
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
Usual management of sickle cell patients with VOS
Primary Outcome Measure Information:
Title
Total dose of morphine
Description
Total dose of morphine (in milligrams), used in the emergency room after initial titration, meaning the dose administered by PCA and secondary titrations in case of recurrence of painful peak with AVS>7
Time Frame
up to 48 hours
Secondary Outcome Measure Information:
Title
Feasibility of implementing the scheme
Description
Number of patents included in the protocol vs. number of potentially eligible patients For patients included during the VR period: the number of VR sessions performed, and the duration of these sessions.
Time Frame
up to 48 hours
Title
Tolerance
Description
Side effects such as headache, nausea, eye pain or dizziness
Time Frame
up to 48 hours
Title
Acceptability
Description
Patient's willingness to use VR again at future VOS Evaluation of patient satisfaction
Time Frame
up to 48 hours
Title
Pain Efficiency
Description
Evaluation of AVS before and after the virtual reality session Numbers of painful areas before and after virtual reality
Time Frame
up to 48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years sickle cell patient consulting in the emergency room for VOS Signature free and informed consent Exclusion Criteria: Consultation in the ER for the same reason in the 14 days prior to inclusion (same episode) Emergency room consultation more than 12 times in the previous year Nausea and vomiting at the time of inclusion History of epilepsy A visually impaired or hard of hearing patient Pregnant patient Previous inclusion in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hélène GOULET, MD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
HOPITAL TENON Service des urgences
City
Paris
ZIP/Postal Code
75020
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Evaluation of Virtual Reality to Save Morphinic in the Treatment of Vaso-occlusive Seizures of Sickle Cell Patients Consulting in the Emergency Room

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