Duration of Music Interventions and PAiN Tolerance in Healthy Individuals: the DOMINANT Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Pain tolerance
研究概览
简要总结
This study will investigate the effect of different durations of music interventions (1, 5 and 20 minutes of music) on pain tolerance.
详细描述
Music interventions reduce perioperative pain and anxiety. However, it is yet unclear how long music needs to be presented in order to have an effect. Therefore, the investigators would like to propose a pilot randomized controlled trial in order to investigate the optimal duration of musical interventions. The main objective of this study is to investigate the effect of different durations of music interventions on pain tolerance (expressed in amperage). Secondary objectives are to investigate the effects of music duration on heart rate variability (expressed in milliseconds) and subjective measurements of emotions, anxiety and pain. Healthy volunteers (age ≥18 years) will be included, and the study will take place at the outpatient clinic of the Center of Pain Medicine, Erasmus Medical Center, Rotterdam.
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
- None
盲法说明
Due to the nature of the study and the music intervention, it is not possible to blind participants and investigators. However, participants will not be informed of the study arm to which they are randomized in advance.
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Between 18 and 64 years of age
- •Sufficient knowledge of the Dutch language to understand the study documents (in the judgement of the attending physician or researcher)
- •Provision of written informed consent by subject
排除标准
- •Significant hearing impairment
- •Current complaints of tinnitus
- •Current use of analgesic medication
- •Presence of acute or chronic pain
- •History of cardiac disease or arrhythmias
- •Current treatment by a medical specialist or general practitioner
- •Professional musician or singer (practicing in average >1 hour each day)
- •Pregnancy
结局指标
主要结局
Pain tolerance
时间窗: At the end of the intervention, after the 20 minutes of listening to music or sitting in silence. Measured at the same day as the experiment.
The primary objective of the study is the pain tolerance. This tolerance will be measured using electric stimuli directly after the 20 minutes of listening to music or sitting in silence. Each measurement will be performed three times. Results will be expressed in amperage.
次要结局
- Level of perceived anxiety, Spielberger State-Trait Anxiety Inventory (STAI)-6 questionnaire(At baseline and immediately after the intervention, after the electric stimuli. Measured at the same day as the experiment.)
- Music listening Questionnaire(At baseline. Measured at the same day as the experiment.)
- Pain intensity(At the end of the intervention, immediately after each electric stimulus. Measured at the same day as the experiment.)
- Heart rate variability (HRV)(During the 20 minutes of listening to music or sitting in silence, and during the eletric stimuli directly after those 20 minutes. Measured at the same day as the experiment.)
- Valence and arousal, Self-Assessment manikin (SAM) questionnaire(At baseline and immediately after the intervention, after the electric stimuli. Measured at the same day as the experiment.)
- Pain unpleasantness(At the end of the intervention, immediately after each electric stimulus. Measured at the same day as the experiment.)
研究者
Markus Klimek
Vice-Chairman / Director Residency Training Program, Department of Anesthesiology
Erasmus Medical Center