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

• Sponsor: Assistance Publique - Hôpitaux de Paris (Other)
• Overall Status: Completed
• CT.gov ID: NCT04756375
• Collaborator: (none)
• Enrollment: 97
• Location: 1
• Arms: 2
• Actual Duration (Months): 6
• Patients Per Site Per Month: 16.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Vaso-occlusive Crisis; Sickle Cell Disease	Device: Virtual Reality; Other: Usual Care	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 97 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• 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
• Actual Study Start Date: Mar 4, 2021
• Actual Primary Completion Date: Sep 2, 2021
• Actual Study Completion Date: Sep 2, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: INTERVENTION Use of virtual reality in the management of sickle cell patients with VOS	Device: Virtual Reality; Use of virtual reality in the management of sickle cell patients with VOS
Other: NO INTERVENTION	Other: Usual Care; Usual management of sickle cell patients with VOS

Outcome Measures

Primary Outcome Measures

1. Total dose of morphine [up to 48 hours]

   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

1. Feasibility of implementing the scheme [up to 48 hours]

   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.

2. Tolerance [up to 48 hours]

   Side effects such as headache, nausea, eye pain or dizziness

3. Acceptability [up to 48 hours]

   Patient's willingness to use VR again at future VOS Evaluation of patient satisfaction

4. Pain Efficiency [up to 48 hours]

   Evaluation of AVS before and after the virtual reality session Numbers of painful areas before and after virtual reality

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	HOPITAL TENON Service des urgences	Paris		France	75020

Sponsors and Collaborators

• Assistance Publique - Hôpitaux de Paris

Investigators

• Principal Investigator: Hélène GOULET, MD, Assistance Publique - Hôpitaux de Paris

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Assistance Publique - Hôpitaux de Paris
• ClinicalTrials.gov Identifier: NCT04756375
• Other Study ID Numbers: APHP190729; IDRCB2020-A00599-30
• First Posted: Feb 16, 2021
• Last Update Posted: Oct 18, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Assistance Publique - Hôpitaux de Paris: Virtual reality; Vaso occlusive seizure; Sickle Cell Disease; Emergency Room; Pain
• Additional relevant MeSH terms: Seizures; Anemia, Sickle Cell; Emergencies

Study Results

No Results Posted as of Oct 18, 2021