Non-Invasive Vagus Nerve Stimulation in Burn Patients During Dressing

NCT07566910 | Enrolling By Invitation

• 1 other identifier: KartalYanikH
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Burn Injury

Keywords

Burn patients; Burn dressing; Non-invasive vagus nerve stimulation; Pain; Anxiety; Quality of life

Outcome Measures

Primary Outcomes (3)

• Change in Pain Intensity

  Pain intensity will be assessed using the Visual Analog Scale. Participants will mark their pain level on a 100-mm line, where 0 indicates no pain and 100 indicates the worst imaginable pain. Higher scores indicate greater pain intensity. Pain will be measured before and after each dressing session.

  Before and after each dressing session through 7 dressing sessions, approximately 14 days

• Change in Anxiety Level

  Anxiety level will be assessed using the Beck Anxiety Inventory. The scale includes 21 items scored from 0 to 3, with a total score ranging from 0 to 63. Higher scores indicate higher levels of anxiety.

  Before the first dressing session and before the seventh dressing session, approximately 14 days

• Change in Quality of Life

  Quality of life will be assessed using the SF-12 Health Survey. The SF-12 evaluates physical and mental health components of quality of life. Higher scores indicate better health-related quality of life.

  Before the first dressing session and before the seventh dressing session, approximately 14 days

Study Arms (3)

Non-Invasive Vagus Nerve Stimulation Before Dressing

EXPERIMENTAL

Participants in this group will receive non-invasive vagus nerve stimulation for 20 minutes before each dressing procedure, in addition to standard dressing care.

Device: Non-Invasive Vagus Nerve Stimulation; Procedure: Standard Dressing Care

Non-Invasive Vagus Nerve Stimulation During Dressing

EXPERIMENTAL

Participants in this group will receive non-invasive vagus nerve stimulation for 20 minutes during each dressing procedure, in addition to standard dressing care.

Device: Non-Invasive Vagus Nerve Stimulation; Procedure: Standard Dressing Care

Standard Dressing Care

ACTIVE COMPARATOR

Participants in this group will receive standard dressing care only and will not receive non-invasive vagus nerve stimulation.

Procedure: Standard Dressing Care

Interventions

Non-Invasive Vagus Nerve Stimulation DEVICE

Non-invasive vagus nerve stimulation will be applied using electrodes placed on the tragus and the inner and posterior surfaces of the concha of the external ear. Stimulation will be applied continuously for 20 minutes with a biphasic asymmetric waveform, a pulse duration of 300 microseconds, and a frequency of 25 Hz. The stimulation intensity will be increased in 0.1 mA steps until the sensory threshold is reached. If the participant feels unwell during stimulation, the procedure will be stopped.

Non-Invasive Vagus Nerve Stimulation Before Dressing; Non-Invasive Vagus Nerve Stimulation During Dressing

Standard Dressing Care PROCEDURE

Participants will receive standard burn wound dressing care according to the routine clinical procedures of the burn outpatient clinic.

Non-Invasive Vagus Nerve Stimulation Before Dressing; Non-Invasive Vagus Nerve Stimulation During Dressing; Standard Dressing Care

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fenerbahce University: lead

Study Sites (1)

Kartal Dr. Lütfi Kırdar City Hospital Burn Unit

Istanbul, Kartal, 34865, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Burns; Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Sümeyye Akçay, Asst. Prof.

  Fenerbahçe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor will be masked to group allocation. Participants will be assigned to one of three groups, but outcome assessments will be recorded by an assessor who is not involved in the intervention procedures and will not be informed of the participants' group assignments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof.

Model Details: Participants will be randomly assigned to one of three parallel groups: non-invasive vagus nerve stimulation before dressing, non-invasive vagus nerve stimulation during dressing, or standard dressing care only. Each participant will remain in the assigned group throughout the study.

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: May 5, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)