Pain
Conditions
Keywords
Capsaicin, QUTENZA®, Hypnosis, Peripheral Neuropathic
Brief summary
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.
Interventions
OTHERhypnotic message
OTHERmusic therapy
DRUGQUTENZA®
Sponsors
Institut de Cancérologie de Lorraine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compare pain induced by patch QUTENZA® | 1 day | Pain will be evaluated by a numerical scale before, just after, and after installation of the patch |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compare anxiety induced by patch QUTENZA® | 1 day | Anxiety will be evaluated by a numerical scale before, just after, and after installation of the patch |
| 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 | — |
Countries
France
Outcome results
None listed