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NCT Number: NCT07566871

Effect of Non-Invasive Vagus Nerve Stimulation 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.

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Key information

Conditions

Burn Injury Anxiety Disorders Burns Dyssomnias Mental Disorders Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Pruritus Signs and Symptoms Skin Diseases Skin Manifestations Skin and Connective Tissue Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kartal Dr. Lütfi Kırdar City Hospital Burn Unit

Istanbul, Kartal, 34865, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-Invasive Vagus Nerve Stimulation

Device

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.

Conventional Physiotherapy

Other

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.

Primary outcomes

  1. Change in Anxiety Level

    Time frame: 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.

  2. Change in Sleep Quality

    Time frame: 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.

  3. Change in Pain Intensity

    Time frame: 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.

  4. Change in Pruritus Severity

    Time frame: 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.

  5. Change in Root Mean Square of Successive Differences

    Time frame: 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.

  6. Change in Standard Deviation of Normal-to-Normal Intervals

    Time frame: 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.

  7. Change in Low-Frequency/High-Frequency Ratio

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Fenerbahce University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 5, 2026
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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