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Effect of Non-Invasive Vagus Nerve Stimulation in Burn Patients

StatusEnrolling by Invitation
PhaseNot applicable
Started
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Record status
This record was last updated July 7, 2026 (before its estimated September 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Minor Start date changed from estimate of May 2026 to May 4, 2026v3
  2. Notable Primary endpoint(s) modifiedv2
  3. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
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This study will evaluate the effects of non-invasive vagus nerve stimulation (nVNS) in adults with burn injuries. Burn patients may experience anxiety, poor sleep quality, pain, itching, and changes in autonomic nervous system function during recovery. Participants will be randomly assigned to one of two groups. The intervention group will receive conventional physiotherapy plus nVNS, and the control group will receive conventional physiotherapy only. Both groups will receive treatment 5 days per week for a total of 10 sessions. nVNS will be applied through electrodes placed on the external ear for 20 minutes per session. Anxiety, sleep quality, pain, itching, and autonomic function will be assessed before and after the treatment period. Autonomic function will be evaluated using heart rate variability measurements. The results will help determine whether nVNS may be a useful supportive method in the rehabilitation of burn patients.
Trial Details
NCT Number NCT07566871
Lead Sponsor Fenerbahce University
Conditions
(from sponsor)
Burn Injury
Related terms Anxiety Disorders, Burns, Pain, Pruritus, Sleep Initiation and Maintenance Disorders
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov