Clinical trial NCT04794608: Hypnosis in Virtual Reality in Patients in Protector Isolation Room for Aplasia in Clinical Hematology.
Official title: Hypnosis in Virtual Reality in Patients in Protector Isolation Room for Aplasia in Clinical Hematology. Monocentric, Comparative, Randomized, Open Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aplasia
Keywords: Aplasia
Anxiety
Hypnosis
Virtual reality
Protector isolation
Lead sponsor: Hôpital Privé Sévigné
Sponsor class: OTHER
First posted: 2021-03-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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).

Primary outcomes:
measure: Compare the change in anxiety in the HYPNOVR group versus the change in anxiety in the "selected activity" control group.
timeFrame: For up to 3 days, every days (before and after the virtual reality hypnosis sessions), starting on day of inclusion.
Secondary outcomes:
measure: Test the hypothesis that medical hypnosis in virtual reality is accompagnied by a variation of the chronic pain (in comparision with a control group).
timeFrame: For up to 3 days, every days (before and after the virtual reality hypnosis sessions), starting on day of inclusion.
measure: 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).
timeFrame: For up to 3 days, every days (record before the virtual reality hypnosis sessions), starting on day of inclusion.
measure: 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).
timeFrame: For up to 3 days, every days (record before the virtual reality hypnosis sessions), starting on day of inclusion.
measure: Test the hypothesis that medical hypnosis in virtual reality is accompagnied by a good patient satisfaction regarding the use of the virtual reality headset.
timeFrame: For up to 3 days, every days (record after the virtual reality hypnosis sessions), starting on day of inclusion.
Other outcomes:
Locations:
city: Cesson-Sévigné
country: France
facility: Hôpital Privé Sévigné
Study officials:
affiliation: Hôpital Privé Sévigné
name: Anne-Violaine DONCKER, MD
role: PRINCIPAL_INVESTIGATOR
References: