Evaluation of Hypnosis in Virtual Reality on the Anxiety of Patients With Metastatic Prostate Cancer Over Chemotherapy
NCT ID: NCT04533958
Last Updated: 2025-05-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2020-09-28
2027-02-28
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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HypnoVR Arm
During each Docetaxel infusion, patients benefit from a 20-minute session of medical hypnosis in virtual reality.
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.
Control Arm
Patients receive the docetaxel infusions under standard conditions (no medical hypnosis in virtual reality intervention)
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
MALE
No
Sponsors
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Saint-Gregoire Private Hospital Center
OTHER
Responsible Party
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Principal Investigators
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Xavier ARTIGNAN, MD
Role: PRINCIPAL_INVESTIGATOR
CHP Saint Grégoire
Locations
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Clinique Pasteur-Lanroze
Brest, , France
CHP Saint-Grégoire
Saint-Grégoire, , France
Clinique de la Côte d'Emeraude
St-Malo, , France
Hospital Lusiadas Amadora
Amadora, , Portugal
Hospital Lusiadas Lisboa
Lisbon, , Portugal
Hospital Lusiadas Porto
Porto, , Portugal
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2019-A03336-51
Identifier Type: -
Identifier Source: org_study_id
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