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Effect of Non-Invasive Vagus Nerve Stimulation in Burn Patients

4 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Iscrizione su invito

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

60

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Dispositivo: 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.
Altro: 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.
Comparatore attivo: 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.
Altro: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Anxiety Level
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Fenerbahce University

Investigatori

  • Investigatore principale: Sümeyye Akçay, Asst. Prof., Fenerbahçe University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 maggio 2026

Completamento primario (Stimato)

1 settembre 2026

Completamento dello studio (Stimato)

1 settembre 2026

Date di iscrizione allo studio

Primo inviato

28 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

28 aprile 2026

Primo Inserito (Effettivo)

5 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

7 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

4 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • KartalHosp

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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