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

NCT ID: NCT04794608

Last Updated: 2025-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-17
• Study Completion Date: 2024-02-28

Brief Summary

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.

Detailed 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.

Conditions

Aplasia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

HypnoVR Arm

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

Group Type: EXPERIMENTAL

HYPNO VR® device

Intervention Type: DEVICE

The HYPNO VR® device is a software application of medical hypnosis in the treatment of pain and anxiety. It is associated with equipment: a virtual reality headset and a headphone.

Before each session of hypnosis, the nursing staff offers patients the choices: visual universe, musical theme, male or female voice. The nursing staff selects the program, selects a duration of 20 minutes and presses start to start the medical hypnosis session in virtual reality.

After completing the hypnotic trance sequence, as in a classic session, the patient is brought back to the "return" and exit hypnosis phase under the supervision of the nursing staff.

Control Arm

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

HYPNO VR® device

The HYPNO VR® device is a software application of medical hypnosis in the treatment of pain and anxiety. It is associated with equipment: a virtual reality headset and a headphone.

Before each session of hypnosis, the nursing staff offers patients the choices: visual universe, musical theme, male or female voice. The nursing staff selects the program, selects a duration of 20 minutes and presses start to start the medical hypnosis session in virtual reality.

After completing the hypnotic trance sequence, as in a classic session, the patient is brought back to the "return" and exit hypnosis phase under the supervision of the nursing staff.

Intervention Type: DEVICE

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hôpital Privé Sévigné

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anne-Violaine DONCKER, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Privé Sévigné

Locations

Hôpital Privé Sévigné

Cesson-Sévigné, , France

Countries

France

Other Identifiers

2020-A02561-38

Identifier Type: -

Identifier Source: org_study_id