Hypnosis in Virtual Reality in Patients in Protector Isolation Room for Aplasia in Clinical Hematology. (Hyp_Hem)

Hôpital Privé Sévigné

Status: Completed

Conditions: Aplasia

Treatments: Device: HYPNO VR® device

Study type: Interventional

Funder types: Other

Identifiers

NCT04794608

2020-A02561-38

Details and patient eligibility

About

Hematology patients are frequently treated in hospital for aplasia. Patients are then placed in protective isolation room. This situation of protective isolation can represent a significant source of stress and anxiety for the patient. Hypnosis is already used to treat anxiety in patients with cancer.

The purpose of this study is to evaluate the impact of virtual reality medical hypnosis sessions on anxiety and chronic pain of patients hospitalized for aplasia in order to broaden the supportive care proposals in the clinical hematology service of Sévigné Private Hospital.

Full description

After verifying the patient's eligibility criteria and obtaining the signed informed consent form, the patient is randomized to the arm receiving hypnosis in virtual reality or to the control arm. The study ends after three consecutive days in protector isolation with one session hypnosis in virtual reality per day.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient aged ≥ 18 years.
• Haematological pathology
• Patient hospitalized in protective isolation for aplasia defined by a rate of polymorphonuclear neutrophils <0.5 G / L.
• Patient having signed his informed consent.
• Patient with social security coverage.
• Patient treated and monitored in the center for the duration of the study (maximum 1 month)

Exclusion criteria

• Patient unable to undergo protocol monitoring for psychological, social, family or geographic reasons.
• Patient deprived of his liberty or under guardianship.
• Patient with an underlying or concomitant pathology incompatible with inclusion in the trial, whether psychiatric or somatic
• Patient with a contraindication to the use of virtual reality (psychiatric disorders, unbalanced epilepsy, visual or hearing disorders).

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

60 participants in 2 patient groups

HypnoVR Arm

Experimental group

Description:

During the three days of study in protector isolation, patients benefit from a 20-minute session of medical hypnosis in virtual reality.

Treatment:

Device: HYPNO VR® device

Control Arm

No Intervention group

Description:

During the three days of study in protector isolation, patients benefit from a 20-minute session of activity among those currently proposed in the service of hematology (reading, music, television).