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Non-Invasive Vagus Nerve Stimulation in Burn Patients During Dressing

3 juli 2026 bijgewerkt door: Sümeyye Akçay, Fenerbahce University

The Effects of Non-Invasive Vagus Nerve Stimulation on Pain, Anxiety, and Quality of Life During the Dressing Process in Burn Patients: A Three-Group Comparative Intervention Study

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.

Studie Overzicht

Toestand

Aanmelden op uitnodiging

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Burn injuries are associated with severe pain, psychological distress, and reduced quality of life. Dressing procedures may cause additional procedural pain and anxiety, which can negatively affect patient comfort, treatment adherence, and rehabilitation. Non-invasive vagus nerve stimulation is a neuromodulation method that stimulates the auricular branch of the vagus nerve through electrodes placed on the external ear. This method may modulate autonomic nervous system activity and may have beneficial effects on pain and anxiety.

This randomized, three-group comparative interventional study will include adult burn patients who require repeated dressing procedures. A total of 96 participants will be included, with 32 participants in each group. Participants will be randomly assigned to one of three groups: non-invasive vagus nerve stimulation before dressing, non-invasive vagus nerve stimulation during dressing, or standard dressing care only.

In the first intervention group, non-invasive vagus nerve stimulation will be applied for 20 minutes before the dressing procedure. In the second intervention group, non-invasive vagus nerve stimulation will be applied for 20 minutes during the dressing procedure. In the control group, participants will receive only the standard dressing procedure without non-invasive vagus nerve stimulation.

For participants receiving non-invasive vagus nerve stimulation, electrodes will be 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 using 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.

Participants are expected to undergo dressing procedures every other day for a total of seven sessions. Pain will be evaluated using the Visual Analog Scale before and after each dressing session. Anxiety will be evaluated using the Beck Anxiety Inventory, and quality of life will be evaluated using the SF-12 Health Survey before the first dressing session and before the seventh dressing session. The study will compare changes in pain, anxiety, and quality of life between the three groups.

Studietype

Ingrijpend

Inschrijving (Geschat)

96

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Turkije (Türkiye)
    • Kartal
      • Istanbul, Kartal, Turkije (Türkiye), 34865
        • Kartal Dr. Lütfi Kırdar City Hospital Burn Unit

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Non-Invasive Vagus Nerve Stimulation Before Dressing
Participants in this group will receive non-invasive vagus nerve stimulation for 20 minutes before each dressing procedure, in addition to standard dressing care.
Apparaat: Non-Invasive Vagus Nerve Stimulation
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.
Procedure: Standard Dressing Care
Participants will receive standard burn wound dressing care according to the routine clinical procedures of the burn outpatient clinic.
Experimenteel: Non-Invasive Vagus Nerve Stimulation During Dressing
Participants in this group will receive non-invasive vagus nerve stimulation for 20 minutes during each dressing procedure, in addition to standard dressing care.
Apparaat: Non-Invasive Vagus Nerve Stimulation
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.
Procedure: Standard Dressing Care
Participants will receive standard burn wound dressing care according to the routine clinical procedures of the burn outpatient clinic.
Actieve vergelijker: Standard Dressing Care
Participants in this group will receive standard dressing care only and will not receive non-invasive vagus nerve stimulation.
Procedure: Standard Dressing Care
Participants will receive standard burn wound dressing care according to the routine clinical procedures of the burn outpatient clinic.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Pain Intensity
Tijdsspanne: Before and after each dressing session through 7 dressing sessions, approximately 14 days
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
Tijdsspanne: Before the first dressing session and before the seventh dressing session, approximately 14 days
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
Tijdsspanne: Before the first dressing session and before the seventh dressing session, approximately 14 days
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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Fenerbahce University

Onderzoekers

  • Hoofdonderzoeker: Sümeyye Akçay, Asst. Prof., Fenerbahce University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

4 mei 2026

Primaire voltooiing (Geschat)

1 september 2026

Studie voltooiing (Geschat)

1 september 2026

Studieregistratiedata

Eerst ingediend

28 april 2026

Eerst ingediend dat voldeed aan de QC-criteria

28 april 2026

Eerst geplaatst (Werkelijk)

5 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

7 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

3 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • KartalYanikH

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

Individual participant data will not be shared because the study data will contain sensitive health-related information from burn patients. Data will be used only by the research team for the purposes of this study and will be reported in aggregate form without identifying individual participants.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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