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Enrolling By Invitation NCT07566910

Non-Invasive Vagus Nerve Stimulation in Burn Patients During Dressing

Conditions: Burn Injury

Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: NA
Enrollment: 96
Sponsor: Fenerbahce University

Location: Kartal Dr. Lütfi Kırdar City Hospital Burn Unit Istanbul Kartal

Summary

This study will evaluate the effects of non-invasive vagus nerve stimulation on pain, anxiety, and quality of life in burn patients during the dressing process. Participants will be randomly assigned to one of three groups. One group will receive non-invasive vagus nerve stimulation for 20 minutes before dressing, one group will receive non-invasive vagus nerve stimulation for 20 minutes during dressing, and the control group will receive standard dressing care only. Pain will be assessed using the Visual Analog Scale, anxiety will be assessed using the Beck Anxiety Inventory, and quality of life will be assessed using the SF-12 Health Survey. The study aims to determine whether non-invasive vagus nerve stimulation can reduce dressing-related pain and anxiety and improve quality of life in burn patients.

Eligibility Criteria

Inclusion Criteria: * Aged 18 to 65 years * Having superficial or deep second-degree burns requiring dressing during the acute period * Expected to attend at least 7 dressing sessions * Willing to participate in the study and able to provide written informed consent * Able to read and understand Turkish Exclusion Criteria: * Infection, ulcer, or scar tissue on the auricle * Burns in the head and neck region that prevent application of the device to the auricular vagus nerve area * Metallic implant in the skull * Excessive sensitivity, injury, or inflammation in the ear * Chronic pulmonary and/or cardiac disease * Heart rate below 60 beats per minute * Presence of a pacemaker or cochlear implant * Uncontrolled hypertension * Lack of cooperation * Refusal or inability to sign the informed consent form

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07566910). StuddyBuddy aggregates publicly available trial information.