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

Not Applicable

Completed

• Conditions: Aplasia
• Interventions: Device: HYPNO VR® device

• Registration Number: NCT04794608
• Lead Sponsor: Hôpital Privé Sévigné

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.

Study Timeline

• Study First Submitted: 2021-03-03
• Study First Submitted QC: 2021-03-08
• Study First Posted: 2021-03-12
• Study Start: 2021-06-17
• Primary Completion: 2024-01-30
• Study Completion: 2024-02-28
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-05
• Last Update Posted: 2025-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HypnoVR Arm	HYPNO VR® device	During the three days of study in protector isolation, patients benefit from a 20-minute session of medical hypnosis in virtual reality.

Primary Outcome Measures

Name	Time	Method
Compare the change in anxiety in the HYPNOVR group versus the change in anxiety in the "selected activity" control group.	For up to 3 days, every days (before and after the virtual reality hypnosis sessions), starting on day of inclusion.	Comparison of the change in the anxiety "state" by the State Trait Anxiety Inventory (STAI) - State score before (15 minutes) and after (15 minutes) each virtual reality hypnosis session for 3 consecutive days (ie six questionnaires) to the change in the anxiety "state" in patients in the control group (STAI-State score evaluated 15 minutes before and 15 minutes after the patient was offered an activity of his choice). The score is a quantitative variable with values ranging from 20 to 80. The higher the score is, the more important the anxiety is.

Secondary Outcome Measures

Name	Time	Method
Test the hypothesis that medical hypnosis in virtual reality is accompagnied by a variation of the chronic pain (in comparision with a control group).	For up to 3 days, every days (before and after the virtual reality hypnosis sessions), starting on day of inclusion.	Comparison of the change in chronic pain before and after each hypnosis session for the Hypno VR group, for 3 consecutive days, i.e. six assessments, in comparison with change in chronic pain in patients in the control group (also six assessments). The scale used is the visual analogical scale of pain which comes in the form of a ruler on which a cursor can be moved from end to end (from "no pain" to "maximum imaginable pain"). The rear face of the ruler, intended for the evaluator, has a graduation from 0 to 100 mm. The higher the score is, the more important the pain is.
Test the hypothesis that medical hypnosis in virtual reality is accompanied by a modification in the consumption of analgesic treatments (in comparision with a control group).	For up to 3 days, every days (record before the virtual reality hypnosis sessions), starting on day of inclusion.	Comparison of the proportion of analgesic treatments consumption (posology stopped, added or changed) for each day of the study between the two arms.
Test the hypothesis that medical hypnosis in virtual reality is accompanied by a modification in the consumption of anxiolytics treatments (in comparision with a control group).	For up to 3 days, every days (record before the virtual reality hypnosis sessions), starting on day of inclusion.	Comparison of the proportion of anxiolytics treatments consumption (posology stopped, added or changed) for each day of the study between the two arms.
Test the hypothesis that medical hypnosis in virtual reality is accompagnied by a good patient satisfaction regarding the use of the virtual reality headset.	For up to 3 days, every days (record after the virtual reality hypnosis sessions), starting on day of inclusion.	Assessment of the overall satisfaction of the patient in the HYPNO VR group by the satisfaction questionnaire (ie a questionnaire after each hypnosis session for 3 consecutive days). A level of satisfaction (on a 11-point scale from 0 to 10) of the patient will be measure for the state of relaxation, security, understanding, overall satisfaction.

Trial Locations

Locations (1)

Hôpital Privé Sévigné; 🇫🇷 Cesson-Sévigné, France