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Completed

NCT Number: NCT02822625

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

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.

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Key information

Conditions

Pain Nervous System Diseases Neuritis Neurologic Manifestations Neuromuscular Diseases Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, 54519, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

QUTENZA®

Drug

hypnotic message

Other

Music Therapy

Other

Primary outcomes

  1. Compare pain induced by patch QUTENZA®

    Time frame: 1 day

    Pain will be evaluated by a numerical scale before, just after, and after installation of the patch

Secondary outcomes

  1. Compare anxiety induced by patch QUTENZA®

    Time frame: 1 day

    Anxiety will be evaluated by a numerical scale before, just after, and after installation of the patch

  2. Compare the real time of application of the patch

    Time frame: 1 day

  3. Determine the number of patients who listened the message in totality.

    Time frame: 1 day

  4. Compare the percentage of patients with a sensation of time distortion

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Institut de Cancérologie de Lorraine

Other

Registry information

Official study title

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

Acronym: ENHYZA

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jul 4, 2016
Registry last updated
Apr 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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