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

NCT04794608 | Completed

• 1 other identifier: 2020-A02561-38
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Aplasia

Keywords

Aplasia; Anxiety; Hypnosis; Virtual reality; Protector isolation

Outcome Measures

Primary Outcomes (1)

• Compare the change in anxiety in the HYPNOVR group versus the change in anxiety in the "selected activity" control group.

  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.

  For up to 3 days, every days (before and after the virtual reality hypnosis sessions), starting on day of inclusion.

Secondary Outcomes (4)

• 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.

• 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.

• 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.

• 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.

Study Arms (2)

HypnoVR Arm

EXPERIMENTAL

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

Device: HYPNO VR® device

Control Arm

NO INTERVENTION

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).

Interventions

HYPNO VR® device 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.

HypnoVR Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Patient unable to undergo protocol monitoring for psychological, social, family or geographic reasons.
• Patient deprived of his liberty or under guardianship.
• Patient with a contraindication to the use of virtual reality (psychiatric disorders, unbalanced epilepsy, visual or hearing disorders).

Sponsors & Collaborators

• Hôpital Privé Sévigné: lead

Study Sites (1)

Hôpital Privé Sévigné

Cesson-Sévigné, 35520, France

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Anne-Violaine DONCKER, MD

  Hôpital Privé Sévigné

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2021
• First Posted: March 12, 2021
• Study Start: June 17, 2021
• Primary Completion: January 30, 2024
• Study Completion: February 28, 2024
• Last Updated: February 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)