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

Aplasia Clinical Trial

— Hyp_Hem  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04794608
• Other study ID #: 2020-A02561-38
• Status: Recruiting
• Phase: N/A
• Start date: June 17, 2021
• Est. completion date: September 2023

Study information

• Verified date: November 2022
• Source: Hôpital Privé Sévigné
• Contact: BELLEC-FAGOT
• Phone: 0637110376
• Email: mbellecfagot[@]vivalto-sante.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Aplasia

Intervention

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.

Locations

Country	Name	City	State
France	Hôpital Privé Sévigné	Cesson-Sévigné

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital Privé Sévigné

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Test the hypothesis that medical hypnosis in virtual reality is accompagnied by a variation of the chronic pain (in comparision with a control group).	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.
Secondary	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).	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.
Secondary	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).	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.
Secondary	Test the hypothesis that medical hypnosis in virtual reality is accompagnied by a good patient satisfaction regarding the use of the virtual reality headset.	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.