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E-MOHS Trial of TENS and Vibration During Local Anesthesia

Study acronym: E-MOHS
StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record History

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  1. Secondary endpoints: details revised at 1 of 7 entries
    • Study sites revised (3)
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The E-MOHS Trial is a randomized controlled trial evaluating whether active vibration plus transcutaneous electrical nerve stimulation reduces pain during local anesthetic infiltration in adults undergoing Mohs micrographic surgery or dermatologic excision. Participants will be randomized to active vibration:TENS or sham TENS during the first local anesthetic administration. The primary outcome is patient-reported infiltration pain during active local anesthetic infiltration, measured using the 11-point Numeric Rating Scale. Secondary outcomes include infiltration pain measured using a Visual Analog Scale, perioperative anxiety, participant satisfaction, willingness to reuse the device, operator-rated ease of use and sterile-field compatibility, blinding integrity, and adverse events.
Trial Details
NCT Number NCT07852455
Lead Sponsor University of Minnesota
Conditions
(from sponsor)		 Pain, Procedural Pain, Local Anesthesia, Mohs Surgery, Skin Cancer
Related terms Pain, Procedural Pain, Skin Neoplasms
Enrollment 90 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov