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临床试验/NCT07566910
NCT07566910Enrolling By Invitation不适用

The Effects of Non-Invasive Vagus Nerve Stimulation on Pain, Anxiety, and Quality of Life During the Dressing Process in Burn Patients: A Three-Group Comparative Intervention Study

Fenerbahce University1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2026年5月4日最近更新:
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
96
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 on pain, anxiety, and quality of life in burn patients during the dressing process. Participants will be randomly assigned to one of three groups. One group will receive non-invasive vagus nerve stimulation for 20 minutes before dressing, one group will receive non-invasive vagus nerve stimulation for 20 minutes during dressing, and the control group will receive standard dressing care only. Pain will be assessed using the Visual Analog Scale, anxiety will be assessed using the Beck Anxiety Inventory, and quality of life will be assessed using the SF-12 Health Survey. The study aims to determine whether non-invasive vagus nerve stimulation can reduce dressing-related pain and anxiety and improve quality of life in burn patients.

详细描述

Burn injuries are associated with severe pain, psychological distress, and reduced quality of life. Dressing procedures may cause additional procedural pain and anxiety, which can negatively affect patient comfort, treatment adherence, and rehabilitation. Non-invasive vagus nerve stimulation is a neuromodulation method that stimulates the auricular branch of the vagus nerve through electrodes placed on the external ear. This method may modulate autonomic nervous system activity and may have beneficial effects on pain and anxiety.

This randomized, three-group comparative interventional study will include adult burn patients who require repeated dressing procedures. A total of 96 participants will be included, with 32 participants in each group. Participants will be randomly assigned to one of three groups: non-invasive vagus nerve stimulation before dressing, non-invasive vagus nerve stimulation during dressing, or standard dressing care only.

In the first intervention group, non-invasive vagus nerve stimulation will be applied for 20 minutes before the dressing procedure. In the second intervention group, non-invasive vagus nerve stimulation will be applied for 20 minutes during the dressing procedure. In the control group, participants will receive only the standard dressing procedure without non-invasive vagus nerve stimulation.

For participants receiving non-invasive vagus nerve stimulation, electrodes will be placed on the tragus and the inner and posterior surfaces of the concha of the external ear. Stimulation will be applied continuously for 20 minutes using 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 the participant feels unwell during stimulation, the procedure will be stopped.

Participants are expected to undergo dressing procedures every other day for a total of seven sessions. Pain will be evaluated using the Visual Analog Scale before and after each dressing session. Anxiety will be evaluated using the Beck Anxiety Inventory, and quality of life will be evaluated using the SF-12 Health Survey before the first dressing session and before the seventh dressing session. The study will compare changes in pain, anxiety, and quality of life between the three groups.

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 masked to group allocation. Participants will be assigned to one of three groups, but outcome assessments will be recorded by an assessor who is not involved in the intervention procedures and will not be informed of the participants' group assignments.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 18 to 65 years
  • Having superficial or deep second-degree burns requiring dressing during the acute period
  • Expected to attend at least 7 dressing sessions
  • Willing to participate in the study and able to provide written informed consent
  • Able to read and understand Turkish

排除标准

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

研究组 & 干预措施

Non-Invasive Vagus Nerve Stimulation Before Dressing

Experimental

Participants in this group will receive non-invasive vagus nerve stimulation for 20 minutes before each dressing procedure, in addition to standard dressing care.

干预措施: Standard Dressing Care (Procedure)

Standard Dressing Care

Active Comparator

Participants in this group will receive standard dressing care only and will not receive non-invasive vagus nerve stimulation.

干预措施: Standard Dressing Care (Procedure)

Non-Invasive Vagus Nerve Stimulation Before Dressing

Experimental

Participants in this group will receive non-invasive vagus nerve stimulation for 20 minutes before each dressing procedure, in addition to standard dressing care.

干预措施: Non-Invasive Vagus Nerve Stimulation (Device)

Non-Invasive Vagus Nerve Stimulation During Dressing

Experimental

Participants in this group will receive non-invasive vagus nerve stimulation for 20 minutes during each dressing procedure, in addition to standard dressing care.

干预措施: Non-Invasive Vagus Nerve Stimulation (Device)

Non-Invasive Vagus Nerve Stimulation During Dressing

Experimental

Participants in this group will receive non-invasive vagus nerve stimulation for 20 minutes during each dressing procedure, in addition to standard dressing care.

干预措施: Standard Dressing Care (Procedure)

研究者

发起方
Fenerbahce University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sümeyye Akçay

Asst. Prof.

Fenerbahce University

研究点 (1)

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