Effects of Non-Invasive Vagus Nerve Stimulation in Adolescent Burn Patients

NCT07566923 | Enrolling By Invitation

• 1 other identifier: KartalYanık
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the effects of non-invasive vagus nerve stimulation in adolescents aged 12 to 18 years who have burn injuries. The study will include patients who have completed the acute phase after burn injury and who have symptoms such as anxiety, sleep problems, pain, or itching. Participants will be randomly assigned to one of two groups. One group will receive conventional physiotherapy together with non-invasive vagus nerve stimulation. The other group will receive only conventional physiotherapy. The treatment program will be applied 5 days per week for a total of 10 sessions. The study will assess whether non-invasive vagus nerve stimulation improves anxiety, sleep quality, pain, itching, and autonomic nervous system function. These outcomes will be measured before and after the treatment program using clinical scales and heart rate variability measurements.

Conditions

Burn Injury

Keywords

Non-invasive vagus nerve stimulation; Burn injury; Adolescent burn patients; Anxiety; Sleep quality; Pain; Pruritus

Outcome Measures

Primary Outcomes (5)

• Change in anxiety level

  Anxiety level will be assessed using the Beck Anxiety Inventory. The scale consists of 21 items scored from 0 to 3, with a total score ranging from 0 to 63. Higher scores indicate higher anxiety severity.

  Baseline and after completion of the 10-session treatment program, approximately 2 weeks

• Change in sleep-related symptoms

  Sleep-related symptoms will be assessed using the Adolescent Insomnia Scale. The scale includes 13 items and evaluates sleep onset, sleep maintenance, and sleep dissatisfaction/disturbances. Total scores range from 0 to 52, with higher scores indicating more severe insomnia symptoms.

  Baseline and after completion of the 10-session treatment program, approximately 2 weeks

• Change in pain intensity

  Pain intensity will be assessed using the 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 the 10-session treatment program, approximately 2 weeks

• Change in pruritus severity

  Pruritus severity will be assessed using the 12-Item Pruritus Severity Scale. The scale evaluates the severity, frequency, duration, distribution, and impact of itching on daily life and sleep. Higher scores indicate more severe pruritus.

  Baseline and after completion of the 10-session treatment program, approximately 2 weeks

• Change in heart rate variability parameters

  Autonomic nervous system function will be assessed using heart rate variability measurements recorded with a Polar H10 heart rate sensor. RR interval data will be analyzed using Kubios HRV software. Time-domain, frequency-domain, and non-linear heart rate variability parameters will be evaluated.

  Baseline and after completion of the 10-session treatment program, approximately 2 weeks

Study Arms (2)

Non-Invasive Vagus Nerve Stimulation Plus Conventional Physiotherapy

EXPERIMENTAL

Participants in this group will receive non-invasive vagus nerve stimulation in addition to conventional physiotherapy. The treatment will be applied 5 days per week for a total of 10 sessions.

Device: Non-Invasive Vagus Nerve Stimulation; Other: Conventional Physiotherapy

Conventional Physiotherapy

ACTIVE COMPARATOR

Participants in this group will receive conventional physiotherapy only. The treatment will be applied 5 days per week for a total of 10 sessions.

Other: Conventional Physiotherapy

Interventions

Non-Invasive Vagus Nerve Stimulation DEVICE

Non-invasive vagus nerve stimulation will be applied using electrodes placed on the tragus and concha regions of both ears. Stimulation will be delivered with a biphasic asymmetrical waveform, a pulse duration of 300 microseconds, and a frequency of 25 Hz for 20 minutes. The stimulation intensity will be gradually increased in 0.1 mA steps until the participant's sensory threshold is reached. The intervention will be applied 5 days per week for a total of 10 sessions.

Non-Invasive Vagus Nerve Stimulation Plus Conventional Physiotherapy

Conventional Physiotherapy OTHER

Participants will receive an individualized conventional physiotherapy program based on their clinical needs. The program may include strengthening exercises, stretching exercises, balance exercises, active and passive range-of-motion exercises, and interventions for edema management. Each session will last approximately 45 minutes and will be applied 5 days per week for a total of 10 sessions.

Conventional Physiotherapy; Non-Invasive Vagus Nerve Stimulation Plus Conventional Physiotherapy

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Being between 12 and 18 years of age
• Having completed the acute phase after burn injury, with at least 1 month and at most 1 year since the burn injury
• Having second- or third-degree burns involving 5% to 30% of total body surface area
• Having at least one of the following complaints: anxiety, poor sleep quality, pain, or itching
• Written informed consent provided by the parent or legal guardian, and willingness of the participant to take part in the study
• Ability to read and understand Turkish

You may not qualify if:

• Infection, ulcer, or scar tissue on the auricle
• Burn injury in the head and neck region that prevents application of the device to the auricular vagus nerve area
• Metallic implant in the skull, excessive sensitivity in the ear, ear injury, or ear inflammation
• Chronic pulmonary and/or cardiac disease
• Heart rate below 60 beats per minute
• Presence of a pacemaker, cochlear implant, or similar implanted device
• Uncontrolled hypertension
• Lack of cooperation
• Refusal or inability of the parent or legal guardian to sign the informed consent form

Sponsors & Collaborators

• Fenerbahce University: lead

Study Sites (1)

Kartal Dr. Lütfi Kırdar City Hospital Burn Unit

Istanbul, Kartal, 34865, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Burns; Anxiety Disorders; Sleep Initiation and Maintenance Disorders; Pain; Pruritus

Condition Hierarchy (Ancestors)

Wounds and Injuries; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Skin Diseases; Skin and Connective Tissue Diseases; Skin 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 evaluated before and after the intervention by an assessor who will not be involved in treatment allocation or intervention delivery.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof.

Model Details: Participants will be randomly assigned to one of two parallel groups. The intervention group will receive non-invasive vagus nerve stimulation in addition to conventional physiotherapy, while the control group will receive conventional physiotherapy only. Outcomes will be assessed before and after the 10-session treatment program.

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

Locations

TU (1)