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Non-Invasive Vagus Nerve Stimulation in Burn Patients During Dressing

3. juli 2026 oppdatert av: 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.

Studieoversikt

Status

Påmelding etter invitasjon

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Intervensjonell

Registrering (Antatt)

96

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Enhet: 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.
Fremgangsmåte: Standard Dressing Care
Participants will receive standard burn wound dressing care according to the routine clinical procedures of the burn outpatient clinic.
Eksperimentell: 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.
Enhet: 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.
Fremgangsmåte: Standard Dressing Care
Participants will receive standard burn wound dressing care according to the routine clinical procedures of the burn outpatient clinic.
Aktiv komparator: Standard Dressing Care
Participants in this group will receive standard dressing care only and will not receive non-invasive vagus nerve stimulation.
Fremgangsmåte: Standard Dressing Care
Participants will receive standard burn wound dressing care according to the routine clinical procedures of the burn outpatient clinic.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Pain Intensity
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Fenerbahce University

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

4. mai 2026

Primær fullføring (Antatt)

1. september 2026

Studiet fullført (Antatt)

1. september 2026

Datoer for studieregistrering

Først innsendt

28. april 2026

Først innsendt som oppfylte QC-kriteriene

28. april 2026

Først lagt ut (Faktiske)

5. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

7. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • KartalYanikH

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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