NCT07566871

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress5%
May 2026Sep 2026

First Submitted

Initial submission to the registry

April 28, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 5, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

4 months

First QC Date

April 28, 2026

Last Update Submit

April 28, 2026

Conditions

Burn Injury

Keywords

Non-invasive vagus nerve stimulationBurn injuryBurn rehabilitationAnxietySleep qualityPainPruritus

Outcome Measures

Primary Outcomes (5)

  • Change in Anxiety Level

    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

    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

    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

    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 Autonomic Function

    Autonomic nervous system function will be assessed using heart rate variability measurements. 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. Time-domain, frequency-domain, and non-linear heart rate variability parameters will be evaluated.

    Baseline and after completion of 10 treatment sessions, up to 2 weeks

Study Arms (2)

Conventional Physiotherapy Plus Non-Invasive Vagus Nerve Stimulation

EXPERIMENTAL

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.

Device: Non-Invasive Vagus Nerve StimulationOther: Conventional Physiotherapy

Conventional Physiotherapy

ACTIVE COMPARATOR

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.

Other: Conventional Physiotherapy

Interventions

Non-Invasive Vagus Nerve StimulationDEVICE

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 Plus Non-Invasive Vagus Nerve Stimulation
Conventional PhysiotherapyOTHER

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.

Conventional PhysiotherapyConventional Physiotherapy Plus Non-Invasive Vagus Nerve Stimulation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kartal Dr. Lütfi Kırdar City Hospital Burn Unit

Istanbul, Kartal, 34865, Turkey (Türkiye)

Location

MeSH Terms

Conditions

BurnsAnxiety DisordersSleep Initiation and Maintenance DisordersPainPruritus

Condition Hierarchy (Ancestors)

Wounds and InjuriesMental DisordersSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSkin DiseasesSkin and Connective Tissue DiseasesSkin Manifestations

Study Officials

  • Sümeyye Akçay, Asst. Prof.

    Fenerbahçe University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcomes assessor will be blinded to group allocation. Participants will be randomly assigned to the intervention or control group, and outcome assessments will be performed without knowledge of the assigned treatment group.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to one of two parallel groups. The intervention group will receive conventional physiotherapy plus non-invasive vagus nerve stimulation, while the control group will receive conventional physiotherapy only. Both groups will receive treatment 5 days per week for a total of 10 sessions.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof.

Study Record Dates

First Submitted

April 28, 2026

First Posted

May 5, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

May 5, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

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.

Locations

TU(1)