跳至主要内容
临床试验/NCT03914105
NCT03914105已完成不适用

Central Neuromodulation of Pain Through Music in Healthy Subjects (DOUMU1)

University Hospital, Brest2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2019年10月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
2
主要终点
Evaluation of Visual Analogue scale (VAS)

研究概览

简要总结

The present research aims to study the neuromodulatory effect of music on the sensory component of pain. The activation of pain control systems, through music, would pave the way for rehabilitation prospects for patients with a deficit of these controls.

详细描述

Pain is a multidimensional, complex and universal phenomenon that would be faced by almost one in two European adults. To meet the needs in terms of public health, contemporary medicine is gradually reintegrating the use of complementary therapeutic methods. Music therapy is a non-medical intervention that is particularly suited to pain problems. The therapeutic use of music is an economical, practical and safe method. Many clinical studies show that this activity promotes a significant decrease in pain. The ability of passive listening to music to reduce the perception of pain has been called "music-induced analgesia". The neuro-psycho-physiological mechanisms that underlie this phenomenon remain poorly understood. One hypothesis, still discussed, proposes that listening to music would stimulate, directly or indirectly, endogenous mechanisms of modulation of pain, stemming from the brainstem. In individuals undergoing nociceptive tonic stimulation, the specific neuronal activation induced by listening to music demonstrates the involvement of inhibitory descending pathways. A measurement of pain control mechanisms would account for the impact of music on central awareness.

The purpose of this research is therefore to study the neuromodulatory effect of music on the sensory component of pain. The activation of pain control systems, through music, would pave the way for rehabilitation prospects for patients with a deficit of these controls.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
None

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

  • Healthy subjects aged 18 to 65
  • Subjects informed of the constraints of the study and having given their written consent.
  • Subjects benefiting from a social security scheme.

排除标准

  • Subjects under 18 and over 65
  • Subjects who have previously participated in a pain study involving the induced pain test.
  • Subjects with serious psychiatric disorders.
  • Subjects with a diagnosis of acute or chronic pain.
  • Subjects who have been taking antalgic substances for less than a week.
  • Subjects with progressive disease not stabilized by medical treatment.
  • Women in menstruation.
  • Pregnant women.
  • Subjects with a score greater than 10 for the Depressive Dimension on Hospital Anxiety and Depression Scale (HADS)
  • Subjects with an anxiety score "state" higher than anxiety "traits" on the Spielberger condition state / traits anxiety inventory (STAI)
  • Subjects with a score of 32 or higher on the Catastrophe Rating Scale (PCS-CF)
  • Non-cooperating person.
  • Person under legal protection
  • Subjects not benefiting from a social security scheme
  • Refusal of participation

结局指标

主要结局

Evaluation of Visual Analogue scale (VAS)

时间窗: 20 minutes

Visual Analogue Scale (VAS) measured at 2 minutes of stimulation during the temporal summation phase, starting from a basic VAS calibrated at 50/100. Pain is assessed continuously throughout this test using a computerized analog visual scale.

次要结局

  • Difference in average VAS P1-P3(20 minutes)
  • Difference in Pressure Pain Threshold (PPT) before and after the procedure(1 hour and 30 minutes)
  • Average VAS of the subject over the period P1(2 minutes)
  • Average VAS of the subject over the period P2(2 minutes)
  • Average VAS of the subject over the period P3(2 minutes)
  • Evaluation of numerical scale(20 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

Central Neuromodulation of Pain Through Music in... | 临床试验