Efficacity of a Standardized Hypnotic Message During the Application of a Qutenza (Capsaicin) 8% Patch

Study Overview
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Brief Summary
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QUTENZA® is a skin patch with a high concentration of capsaicin (8%) which is the component responsible for spicy peppers. QUTENZA® is indicated for the treatment of peripheral neuropathic pain in non-diabetic adults either alone or in combination with other analgesics. Acute pain experienced during and after the procedure can be relieved by local cooling methods and oral analgesics but the pain remains intense. The hypothesis is that hypnosis via a standardized hypnotic message would increase the local tolerance of the treatment when applying the patch QUTENZA®. To date, there are no studies that can confirm or refute this hypothesis.

Official Title
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Efficacity of a Standardized Hypnotic Message on Pain Experienced During the Application of a Qutenza (Capsaicin) 8% Patch in Patients With Peripheral Neuropathic Pain

Conditions
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Pain

Intervention / Treatment
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* Drug: QUTENZA®
* Other: hypnotic message
* Other: music therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient who have already received at least a QUTENZA® patch Treatment for patient in failure to conventional treatments for neuropathic pain other than diabetics Age >18 years Eastern Cooperative Oncology Group (ECOG) performance status <3 Patient must be affiliated to a social security system Ability to provide written informed consent Patient's legal capacity to consent to study participation and to understand and comply with the requirements of the study Exclusion Criteria: Patient with psychotic disorders Patient with hearing disorders Patient not understanding the French language Age < 18 years Patient requiring analgesic premedication before applying the patch QUTENZA® Patient with a history of hypersensitivity to capsaicin or any of the excipients of the patch Patient deprived of liberty or under supervision

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: arm 1<br>Patients, followed in the institut and for whom a new application of QUTENZA® is required, will receive standard care. | Drug: QUTENZA®<br> <br> |
| Active Comparator: arm 2<br>Patients, followed in the institut and for whom a new application of QUTENZA® is required. Patients will receive QUTENZA® according to standard procedure with a standardized hypnotic message | Drug: QUTENZA®<br> <br> Other: hypnotic message<br> <br> |
| Placebo Comparator: arm 3<br>Patients, followed in the institut and for whom a new application of QUTENZA® is required. Patients will receive QUTENZA® according to standard procedure with a music therapy | Drug: QUTENZA®<br> <br> Other: music therapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare pain induced by patch QUTENZA® | Pain will be evaluated by a numerical scale before, just after, and after installation of the patch | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare anxiety induced by patch QUTENZA® | Anxiety will be evaluated by a numerical scale before, just after, and after installation of the patch | 1 day | 
| Compare the real time of application of the patch |  | 1 day | 
| Determine the number of patients who listened the message in totality. |  | 1 day | 
| Compare the percentage of patients with a sensation of time distortion |  | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Capsaicin, QUTENZA®, Hypnosis, Peripheral Neuropathic