RecruitingNot ApplicableNCT04533958

Evaluation of Hypnosis in Virtual Reality on the Anxiety of Patients With Metastatic Prostate Cancer Over Chemotherapy

Evaluation of Hypnosis in Virtual Reality on the Anxiety of Patients With Metastatic Prostate Cancer Over Chemotherapy Monocentric, Comparative, Randomized, Open Study

Sponsor

Saint-Gregoire Private Hospital Center

Enrollment

60 participants

Start Date

Sep 28, 2020

Study Type

INTERVENTIONAL

Conditions

Metastatic Prostate Cancer

Summary

Prostate cancer is the first cancer in men. The treatment of metastatic prostate cancer with chemotherapy is based on the intravenous administration of docetaxel chemotherapy. Symptoms of anticipatory nausea, linked to anxiety caused by the treatment, may occur. Hypnosis is already used to treat the anxiety of people with cancer and can help treat the symtoms of nausea and vomiting of women with breast cancer. The purpose of the study is to evaluate the effect of medical hypnosis in virtual reality on the anxiety of patients with metastatic prostate cancer receiving Docetaxel chemotherapy treatment in comparison with a control group.

Eligibility

Sex: MALEMin Age: 18 Years

Inclusion Criteria6

Man aged ≥ 18 years
Histologically proven metastatic prostate adenocarcinoma,
Patient undergoing chemotherapy according to the following conventional scheme: 12 courses of Docetaxel every two weeks
Patient who signed their informed consent
Patient benefiting from social security coverage
Patient treated and followed in the center for the duration of the study (6 months maximum).

Exclusion Criteria5

Patient participating in another clinical trial on an experimental molecule
Patient who received previous chemotherapy
Patient unable to submit to protocol monitoring for psychological, social, family or geographic reasons
Patient deprived of their liberty or under guardianship
Patient with underlying or concomitant pathology incompatible with inclusion in the trial, whether psychiatric or somatic

Interventions

DEVICEHYPNO 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 Docetaxel infusion, the nursing staff offers patients the choices: visual universe, musical theme, male or female voice. The nursing staff selects the chemotherapy 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.