Music-based Intervention for the Reduction of Pain and Stress in Healthy Adults
试验速览
- 阶段
- 不适用
- 入组人数
- 90
- 试验地点
- 4
- 主要终点
- Pain Intensity
研究概览
简要总结
This study aims to compare the impact of listening to frequency-modulated music vs. non-modulated music (both researcher-selected), and to test whether there are differential effects on pain and stress perception. Further, these two conditions will be compared to a third condition, in which participants will be exposed to self-selected non-modulated music. It is hypothesized that both researcher-selected frequency-modulated music and self-selected non-modulated music result in stronger decreases in stress and pain compared to researcher-selected non-modulated music, while it is expected that there will be no differences in researcher-selected frequency-modulated music and self-selected non-modulated music. The intervention consists of ten sessions of music listening in the course of three consecutive weeks.
详细描述
This study aims to compare the impact of three different music listening interventions on stress and pain parameters. Participants will be assigned randomly to one of the conditions. In order to avoid expectancy-related effects, participants in both the researcher- and self-selected condition are told that they were allocated randomly to frequency-modulated or non-modulated music. Therefore, subjects are fully blinded with regards to frequency-modulation.
The study design is as follows:
- Baseline measurement: assessment of resting state biological parameters and questionnaires, CPT
- Music listening sessions: ten sessions in three consecutive weeks including:
- 60 minutes of music listening
- CPT following music listening (sessions 1, 3, 6, 10 only)
- Assessments: biological and subjective pain and stress parameters; music and mood related parameters
- Post measurement: assessment of resting state biological parameters and questionnaires, CPT
- Follow-up measurement: 4 weeks after intervention, assessment of resting state biological parameters and questionnaires, CPT
Participants respond to health-related questions (chronic stress, stress reactivity, sleep quality, fatigue, menstrual cycle phase) as well as mood and music-related questions at baseline, post-intervention, and follow-up which are assessed as potential outcome, moderator, and/or control variables. In addition, pain and stress parameters (both biological and subjective) are being assessed at baseline, post-intervention and follow-up as well as in the course of the ten music listening sessions. Furthermore, participants respond to specific music and mood related items following each music listening session (e.g. perceived valence, arousal, familiarity, liking, induced emotions, etc.).
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age: 18 - 35 years
- •BMI: 18.5 - 30 kg/m²
- •full command of the German language
- •capability to attend ten sessions of music listening in our laboratory within three consecutive weeks, each for a duration of one hour
排除标准
- •music related profession or studies
- •absolute hearing (self-report)
- •physical conditions (self-report): tinnitus, hearing impairments, extreme visual impairment, cardiovascular diseases, diabetes, artery occlusive disease, hyper-/hypotension, Raynaud syndrome, chronic pain condition
- •pregnancy, breastfeeding
- •current mental disorders (self-report): major depression, anxiety disorder, eating disorder, substance dependence, psychosis, schizophrenia
- •regular intake of pain drugs/psychotropic drugs
- •not being able to refrain from smoking for 2.5 hours
结局指标
主要结局
Pain Intensity
时间窗: Pre-Post-Change-Design: change from baseline to after 3 weeks
Cold pressor test (CPT): Subjective pain intensity of the test rated via visual analog scale at the time of removal of the hand * baseline assessment before music intervention * post assessment after completion of music intervention (3 weeks)
Pain Tolerance
时间窗: Pre-Post-Change-Design: change from baseline to after 3 weeks
Cold pressor test (CPT): Duration in seconds from immersion of one hand into cold water until removal of the hand: * baseline before music intervention * post assessment after completion of music intervention (3 weeks)
次要结局
- Subjective Stress Experience(Pre-Post-Change-Design: change from baseline to after 3 weeks)
- Physiological Stress: Heart Rate Variability Indices(Pre-Post-Change-Design: change from baseline to after 3 weeks, process analysis during the course of the intervention)
- Physiological Stress: Hair Cortisol(Pre-Post-Change-Design, change from baseline to 4 weeks after post assessment)
- Physiological Stress: Electrodermal activity (EDA)(Pre-Post-Change-Design; change from baseline to after 3 weeks, process analysis during the course of the intervention)
研究者
Urs Nater
Prof. Dr.
University of Vienna