NCT04533958

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Saint-Gregoire Private Hospital Center · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 the 12 courses of docetaxel or premature termination of the study.

Conditions

• Metastatic Prostate Cancer

Interventions

Type	Name	Description
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 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.

Timeline

• Start date: 2020-09-28
• Primary completion: 2025-12-31
• Completion: 2026-02-28
• First posted: 2020-09-01
• Last updated: 2026-04-06

Locations

6 sites across 2 countries: France, Portugal