The Influence of Music Choice on Pain Tolerance in the Context of Social Background in Healthy Volunteers: the MOSART Trial - A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Pain tolerance in amperage
研究概览
简要总结
This study will investigate the effect of different music on the pain tolerance during an increasing electric stimulus in healthy individuals, taking social background into account.
详细描述
The implementation of music in health care settings has shown promising results in alleviating stress, anxiety, and pain-related outcomes. However, the heterogeneity in music selection and characteristics across clinical trials has made it difficult to draw direct comparisons between different music interventions. Additionally, the influence of social background on music perception remains largely unexplored, despite its potential significance. Therefore, a collaboration of medical and sociological experts propose a randomized controlled trial to investigate the effects of two different music interventions on pain tolerance, taking into account the participants' social backgrounds. The primary objective of this study is to assess the impact of self-chosen and researcher-chosen music compared to a control intervention (podcast) on pain tolerance among healthy female volunteers 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
- Crossover
- 主要目的
- Basic Science
- 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 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Between 18 and 60 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
- •Current treatment by a medical specialist or general practitioner
- •History of cardiac disease of arrhythmias
- •(Suspected) pregnancy
- •Diagnosed psychiatric or neurological impairments
- •Electric implants (e.g. pacemakers)
结局指标
主要结局
Pain tolerance in amperage
时间窗: During the intervention, after listening 20 minutes to the music/ podcast. Measured at the same day as the experiment.
The primary object of this study is the pain tolerance by increasing electric stimuli. The measurement will be performed after each intervention while participants are still listening to the music or podcast. Each measurement will be performed three times. Results will be reported in amperage and analyzed with an explorative approach looking at social background.
次要结局
- Pain intensity(Immediately after each increasing electric pain stimuli. Measured at the same day as the experiment)
- Heart rate variability (HRV)(During the intervention. Measured at the same day as the experiment.)
- Music gernes and characteristics(Immediately after the completion of all interventions. Measured at the same day as the experiment.)
- Anxiety measured with State-Trait Anxiety Inventory (STAI)-6(At baseline and immediately after each increasing electric pain stimuli. Measured at the same day as the experiment.)
- Pain unpleasantness(Immediately after each increasing electric pain stimuli. Measured at the same day as the experiment.)
- Affective reaction measures with Self-Assessment Manikin (SAM)(At baseline and immediately after each increasing electric pain stimuli. Measured at the same day as the experiment.)
- Music listening Questionnaire(Immediately after the completion of all interventions. 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