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

November 9, 2022 updated by: Hôpital Privé Sévigné

Hypnosis in Virtual Reality in Patients in Protector Isolation Room for Aplasia in Clinical Hematology. Monocentric, Comparative, Randomized, Open Study.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HypnoVR Arm
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

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.
No Intervention: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare the change in anxiety in the HYPNOVR group versus the change in anxiety in the "selected activity" control group.
Time Frame: 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.
For up to 3 days, every days (before and after the virtual reality hypnosis sessions), starting on day of inclusion.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Test the hypothesis that medical hypnosis in virtual reality is accompagnied by a variation of the chronic pain (in comparision with a control group).
Time Frame: 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.
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).
Time Frame: 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.
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).
Time Frame: 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.
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.
Time Frame: 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.
For up to 3 days, every days (record after the virtual reality hypnosis sessions), starting on day of inclusion.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hôpital Privé Sévigné

Investigators

  • Principal Investigator: Anne-Violaine DONCKER, MD, Hôpital Privé Sévigné

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 17, 2021

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

September 1, 2023

Study Registration Dates

First Submitted

March 3, 2021

First Submitted That Met QC Criteria

March 8, 2021

First Posted (Actual)

March 12, 2021

Study Record Updates

Last Update Posted (Actual)

November 10, 2022

Last Update Submitted That Met QC Criteria

November 9, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2020-A02561-38

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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