The Effects of Non-Invasive Vagus Nerve Stimulation on Anxiety, Sleep Quality, Pain, Itching, and Autonomic Functions in Burn Patients Aged 12-18
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 60
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
Burn injuries may cause long-term physical and psychological symptoms in pediatric and adolescent patients, including pain, itching, sleep problems, anxiety, and changes in autonomic nervous system activity. These symptoms may negatively affect recovery and rehabilitation outcomes.
Non-invasive vagus nerve stimulation is a transcutaneous neuromodulation method that stimulates the auricular branch of the vagus nerve through electrodes placed on the external ear. This stimulation may influence autonomic nervous system regulation and may have potential effects on pain, sleep, anxiety, itching, and physiological recovery.
This study is designed as a randomized interventional study. Adolescents aged 12 to 18 years with burn injuries will be randomly assigned to an intervention group or a control group. The intervention group will receive non-invasive vagus nerve stimulation in addition to conventional physiotherapy. The control group will receive conventional physiotherapy only.
The non-invasive vagus nerve stimulation will be applied through 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. Each stimulation session will last 20 minutes. The stimulation intensity will be gradually increased in 0.1 mA steps until the participant's sensory threshold is reached. If the participant feels unwell during the stimulation, the procedure will be stopped.
Both groups will receive individualized conventional physiotherapy programs based on their clinical needs. These programs may include strengthening exercises, stretching exercises, balance exercises, active and passive range-of-motion exercises, and interventions for edema management. Conventional physiotherapy sessions will last approximately 45 minutes and will be applied 5 days per week for a total of 10 sessions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Non-Invasive Vagus Nerve Stimulation Plus Conventional Physiotherapy
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.
干预措施: Non-Invasive Vagus Nerve Stimulation (Device)
Non-Invasive Vagus Nerve Stimulation Plus Conventional Physiotherapy
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.
干预措施: Conventional Physiotherapy (Other)
Conventional Physiotherapy
Participants in this group will receive conventional physiotherapy only. The treatment will be applied 5 days per week for a total of 10 sessions.
干预措施: Conventional Physiotherapy (Other)
研究者
Sümeyye Akçay
Asst. Prof.
Fenerbahce University