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Effect of Non-Invasive Vagus Nerve Stimulation in Burn Patients

3 juli 2026 uppdaterad av: Sümeyye Akçay, Fenerbahce University

The Effect of Non-Invasive Vagus Nerve Stimulation on Anxiety, Sleep Quality, Pain, Itching, and Autonomic Function in Burn Patients

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.

Studieöversikt

Status

Anmälan via inbjudan

Betingelser

Intervention / Behandling

Detaljerad beskrivning

This study is a randomized controlled experimental study designed to investigate the effects of non-invasive vagus nerve stimulation (nVNS) on anxiety, sleep quality, pain, itching, and autonomic nervous system function in adults with burn injuries.

The study population will consist of patients followed at the Burn Outpatient Clinic of Kartal Dr. Lütfi Kırdar City Hospital in Istanbul, Türkiye. Eligible participants will be adults aged 18 to 65 years who have completed the acute phase of burn injury, whose burn injury occurred between 1 month and 1 year before enrollment, and who have second- or third-degree burns involving 5% to 30% of total body surface area. Participants must also report at least one complaint related to anxiety, sleep quality, pain, or itching and provide written informed consent.

A total of 60 participants are planned to be included. Participants will be randomly assigned in equal numbers to an intervention group or a control group. The intervention group will receive conventional physiotherapy and nVNS. The control group will receive conventional physiotherapy only. Both groups will receive treatment 5 days per week for a total of 10 sessions. Conventional physiotherapy will be planned according to each participant's needs and may include strengthening exercises, stretching exercises, balance exercises, active and passive range-of-motion exercises, and interventions for edema. Each conventional physiotherapy session will last approximately 45 minutes.

In the intervention group, nVNS will be applied using electrodes positioned on the tragus and the anterior and posterior surfaces of the concha of the right and left external ear. Stimulation will be delivered 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 a participant feels unwell during stimulation, the procedure will be stopped.

Outcome assessments will be performed before treatment and after completion of the 10th session. Anxiety will be assessed using the Beck Anxiety Inventory. Sleep quality will be assessed using the Pittsburgh Sleep Quality Index. Pain will be assessed using a visual analog scale. Itching severity will be assessed using the 12-Item Pruritus Severity Scale. Autonomic nervous system function will be evaluated using heart rate variability measurements recorded with a Polar H10 heart rate sensor and analyzed with Kubios HRV software.

The study aims to determine whether adding nVNS to conventional physiotherapy provides additional benefits for psychological symptoms, sleep quality, pain, itching, and autonomic function in burn rehabilitation.

Studietyp

Interventionell

Inskrivning (Beräknad)

60

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

Inclusion Criteria:

  • Adults aged 18 to 65 years
  • Patients who have completed the acute phase of burn injury
  • Burn injury occurred at least 1 month and no more than 1 year before enrollment
  • Second- or third-degree burn involving 5% to 30% of total body surface area
  • Presence of at least one complaint related to anxiety, sleep quality, pain, or itching
  • Able to read and understand Turkish
  • Willing to participate in the study
  • Written informed consent provided

Exclusion Criteria:

  • Infection, ulcer, or scar tissue on the auricle
  • Burn injury in the head and neck region preventing application of the device over the auricular branch of the vagus nerve
  • Metallic implant in the skull
  • Excessive sensitivity, injury, or inflammation in the ear
  • Chronic pulmonary disease and/or chronic cardiac disease
  • Resting heart rate below 60 beats per minute
  • Presence of a pacemaker, cochlear implant, or similar implanted device
  • Uncontrolled hypertension
  • Lack of cooperation or inability to comply with study procedures

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Conventional Physiotherapy Plus Non-Invasive Vagus Nerve Stimulation
Participants in this group will receive conventional physiotherapy plus non-invasive vagus nerve stimulation. Treatment will be provided 5 days per week for a total of 10 sessions. Conventional physiotherapy will last approximately 45 minutes per session. Non-invasive vagus nerve stimulation will be applied to the external ear for 20 minutes per session.
Enhet: Non-Invasive Vagus Nerve Stimulation
Non-invasive vagus nerve stimulation will be applied using a Vagustim device. Electrodes will be placed on the tragus and the anterior and posterior surfaces of the concha of both ears. Stimulation will be applied continuously for 20 minutes per session with a biphasic asymmetric waveform, a pulse duration of 300 microseconds, and a frequency of 25 Hz. Stimulation intensity will be increased in 0.1 mA steps until the sensory threshold is reached. The procedure will be stopped if the participant feels unwell.
Övrig: Conventional Physiotherapy
Conventional physiotherapy will be planned according to each participant's needs and will be provided by a physiotherapist. The program may include strengthening exercises, stretching exercises, balance exercises, active and passive range-of-motion exercises, and interventions for edema. Sessions will be performed 5 days per week for a total of 10 sessions, with each session lasting approximately 45 minutes.
Aktiv komparator: Conventional Physiotherapy
Participants in this group will receive conventional physiotherapy only. Treatment will be provided 5 days per week for a total of 10 sessions. Conventional physiotherapy will be planned according to each participant's needs and may include strengthening exercises, stretching exercises, balance exercises, active and passive range-of-motion exercises, and interventions for edema.
Övrig: Conventional Physiotherapy
Conventional physiotherapy will be planned according to each participant's needs and will be provided by a physiotherapist. The program may include strengthening exercises, stretching exercises, balance exercises, active and passive range-of-motion exercises, and interventions for edema. Sessions will be performed 5 days per week for a total of 10 sessions, with each session lasting approximately 45 minutes.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Anxiety Level
Tidsram: Baseline and after completion of 10 treatment sessions, up to 2 weeks
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 greater anxiety severity.
Baseline and after completion of 10 treatment sessions, up to 2 weeks
Change in Sleep Quality
Tidsram: Baseline and after completion of 10 treatment sessions, up to 2 weeks
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index. The scale evaluates sleep quality and sleep disturbances over the previous month. The total score ranges from 0 to 21, and higher scores indicate poorer sleep quality.
Baseline and after completion of 10 treatment sessions, up to 2 weeks
Change in Pain Intensity
Tidsram: Baseline and after completion of 10 treatment sessions, up to 2 weeks
Pain intensity will be assessed using a visual analog scale. Participants will mark their pain level on a 100-mm line, where higher scores indicate greater pain intensity.
Baseline and after completion of 10 treatment sessions, up to 2 weeks
Change in Pruritus Severity
Tidsram: Baseline and after completion of 10 treatment sessions, up to 2 weeks
Pruritus severity will be assessed using the 12-Item Pruritus Severity Scale. The scale evaluates multiple aspects of itching, including location, duration, frequency, intensity, scratching behavior, emotional effects, sleep disturbance, daily activity effects, and quality-of-life impact. Higher scores indicate more severe itching.
Baseline and after completion of 10 treatment sessions, up to 2 weeks
Change in Root Mean Square of Successive Differences
Tidsram: Baseline and after completion of 10 treatment sessions, up to 2 weeks
Autonomic nervous system function will be assessed using the root mean square of successive differences between normal RR intervals derived from heart rate variability analysis. RR interval data will be recorded with a Polar H10 heart rate sensor during a 5-minute resting measurement and analyzed using Kubios HRV software. The root mean square of successive differences will be reported in milliseconds.
Baseline and after completion of 10 treatment sessions, up to 2 weeks
Change in Standard Deviation of Normal-to-Normal Intervals
Tidsram: Baseline and after completion of 10 treatment sessions, up to 2 weeks
Autonomic nervous system function will be assessed using the standard deviation of normal-to-normal intervals derived from heart rate variability analysis. RR interval data will be recorded with a Polar H10 heart rate sensor during a 5-minute resting measurement and analyzed using Kubios HRV software. The standard deviation of normal-to-normal intervals will be reported in milliseconds.
Baseline and after completion of 10 treatment sessions, up to 2 weeks
Change in Low-Frequency/High-Frequency Ratio
Tidsram: Baseline and after completion of 10 treatment sessions, up to 2 weeks
Autonomic nervous system function will be assessed using the low-frequency/high-frequency ratio derived from heart rate variability analysis. RR interval data will be recorded with a Polar H10 heart rate sensor during a 5-minute resting measurement and analyzed using Kubios HRV software. The low-frequency/high-frequency ratio will be reported as a ratio.
Baseline and after completion of 10 treatment sessions, up to 2 weeks

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Fenerbahce University

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

4 maj 2026

Primärt slutförande (Beräknad)

1 september 2026

Avslutad studie (Beräknad)

1 september 2026

Studieregistreringsdatum

Först inskickad

28 april 2026

Först inskickad som uppfyllde QC-kriterierna

28 april 2026

Första postat (Faktisk)

5 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

7 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

3 juli 2026

Senast verifierad

1 juli 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • KartalHosp

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

Individual participant data will not be shared because the dataset will contain sensitive health-related information from burn patients. Data will be used only by the research team for the purposes approved by the ethics committee, while maintaining participant confidentiality.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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