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临床试验/NCT04862832
NCT04862832已完成不适用

Reduction of Thermal Pain From a Personalized Musical Intervention : Effect of Musical Preference

Association de Musicothérapie Applications et Recherches Cliniques1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2021年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
33
试验地点
1
主要终点
Pain level change from baseline to the end of music intervention

研究概览

简要总结

This is a randomized, 3-days study with the objective to compare the modulation of pain from our musical intervention to the CPT-induced analgesia and silence. The mean pain felt before and after CPT, the silence, and at three times points for the music conditions, 2.20 minutes, 11.30 minutes and 20 minutes, will be evaluated.

Based on previous data, the sample size has been estimated, and 30 participants will be enrolled.

They will undergo four conditions: CPT, silence, Most-Liked Music (MLM) and Least-Liked Music.

The music used will be Music Care, a personalized musical intervention used in clinical settings. It has a U shape in six sections that each have different tempi, number of instruments and volume.

There will be two music conditions: the most-liked-music (MLM) and least-liked-music (LLM) conditions. The sequence rated the highest will be listened to during the MLM and the one rated the lowest will be listened during the LLM condition. MLM will be considered as a score between 7 and 10 on the preference scale. LLM will be considered as a score between 0 and 4.

The cold pressor test will consist in the immersion of the participants' arm in 10 degrees circulating water for two minutes.

The silence condition will consist of six minutes in which the participants stay seated on the examination chair without access to their phones or other provided distractions.

There will be three testing days for each participants. They will be seated in a comfortable chair in a quiet room. The first day, before the pain tests started, consent form will be read and signed by the participants. After, the MLM and LLM will be determined. Then, the sociodemographic questionnaire, the two State Trait Anxiety Inventory (STAI) subscales, Beck Depression Inventory (BDI) and Pain Catastrophizing Scale (PCS) will be administered. Finally, a first two minutes pain test will be performed (T1), the CPT and a second pain test (T2).

The second and third day will consist of first the STAI, the state subscale, the silence condition and then one music condition. The order of music condition will be randomized. The silence condition will consist of a first pain test (T3 or T8), six minutes of silence and then a second pain test (T4 or T9). Those 6 minutes will be chosen in order to equal the duration between the end of the first pain test and the start of the second one of the music intervention condition. In fact, for the music condition, whether it's the MLM or LLM, the first pain tests will be performed at 2.20 minutes after the music started (T5 or T10). The second will be after the relaxation phase at 11.30 minutes (T6 or T11) and the third after the whole 20-minutes cycle (T6 or T12). A post music condition score of the MLM and LLM on the same preference scale as the selection will be administered.

Quantitative data will be described using mean, standard deviation, median, extreme values (minimum and maximum) and the number of missing data.

Qualitative data will be described by their distributions in terms of numbers and percentages by class as well as the number of missing data.

The normality condition will be verified using the Shapiro-Wilk test. Quantitative variables will be compared by the paired Student test if conditions were checked or by the non-parametric test of the signed Wilcoxon ranks, as part of the comparison of 2 modalities. The quantitative variables will be compared between the 3 conditions using a repeated-measure ANOVA or Friedman test.

Tests will be bilateral, with a threshold of 5%.

详细描述

Background: Music is used as a management technique for pain in multiple clinical settings. Music-induced analgesia (MIA) seems to be using the endogenous descending pain modulatory system. This latter is demonstrated by the The Cold Pressor Test (CPT), used here alongside silence as a control condition for MIA.

Study design: This is a randomized, 3-days study with the objective to compare the modulation of pain from our musical intervention to the CPT-induced analgesia and silence.

Objectives: The objective of this study will be to compare the modulation of pain from our musical intervention to the CPT-induced analgesia and silence. In addition, the difference in pain modulation from the most-liked music and least-liked music conditions will be evaluated. It is predicted that most liked music will reduce pain perception in a similar fashion than the CPT and more than the least liked music and silence.

The mean pain felt before and after CPT, the silence, and at three times points for the music conditions, 2.20 minutes, 11.30 minutes and 20 minutes, will be compared.

Participants: Based on previous data, the sample size has been estimated, and 30 participants will be enrolled.

研究设计

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

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • healthy adults

排除标准

  • musicians with knowledge of music theory
  • diagnosed and taking medication for chronic pain
  • skin problems
  • psychological or neurological pathologies

结局指标

主要结局

Pain level change from baseline to the end of music intervention

时间窗: Collected before the music starts (considered as baseline), and after the whole 20-minutes cycle.

Pain level measured using a Computerized Visual Analogue Scale (VAS) from 0: "no pain" to 100: "most intense pain tolerable".

次要结局

  • Pain level change from baseline to the relaxation phase of music intervention(Collected before the music starts (considered as baseline) and after the relaxation phase at 11.30 minutes.)
  • Pain level change from baseline to the beginning of music intervention(Collected before the music starts (considered as baseline) and 2.20 minutes after the music start.)
  • Perception of time(20 minutes after music starts)

研究者

发起方
Association de Musicothérapie Applications et Recherches Cliniques
申办方类型
Other
责任方
Sponsor

研究点 (1)

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