Effect of Non-Invasive Vagus Nerve Stimulation in Burn Patients
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.
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Kartal
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Istanbul, Kartal, 터키 (Türkiye), 34865
- Kartal Dr. Lütfi Kırdar City Hospital Burn Unit
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
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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 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.
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활성 비교기: 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.
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Anxiety Level
기간: Baseline and after completion of 10 treatment sessions, up to 2 weeks
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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.
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Baseline and after completion of 10 treatment sessions, up to 2 weeks
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Change in Sleep Quality
기간: Baseline and after completion of 10 treatment sessions, up to 2 weeks
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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.
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Baseline and after completion of 10 treatment sessions, up to 2 weeks
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Change in Pain Intensity
기간: Baseline and after completion of 10 treatment sessions, up to 2 weeks
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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.
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Baseline and after completion of 10 treatment sessions, up to 2 weeks
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Change in Pruritus Severity
기간: Baseline and after completion of 10 treatment sessions, up to 2 weeks
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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.
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Baseline and after completion of 10 treatment sessions, up to 2 weeks
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Change in Root Mean Square of Successive Differences
기간: Baseline and after completion of 10 treatment sessions, up to 2 weeks
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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.
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Baseline and after completion of 10 treatment sessions, up to 2 weeks
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Change in Standard Deviation of Normal-to-Normal Intervals
기간: Baseline and after completion of 10 treatment sessions, up to 2 weeks
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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.
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Baseline and after completion of 10 treatment sessions, up to 2 weeks
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Change in Low-Frequency/High-Frequency Ratio
기간: Baseline and after completion of 10 treatment sessions, up to 2 weeks
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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.
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Baseline and after completion of 10 treatment sessions, up to 2 weeks
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공동 작업자 및 조사자
수사관
- 수석 연구원: Sümeyye Akçay, Asst. Prof., Fenerbahçe University
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- KartalHosp
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
화상 부상에 대한 임상 시험
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The Second Hospital of Qinhuangdao완전한
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National Health Service, United KingdomUniversity of Bradford완전한
Non-Invasive Vagus Nerve Stimulation에 대한 임상 시험
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University of Malaga아직 모집하지 않음스트레스 | 불명증 | 수면 장애