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

Study Overview
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Brief Summary
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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%.

Detailed Description
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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. Intervention: Each participant 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. Measures: 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 STAI subscales, BDI and 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. Statistical methods: 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%.

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

Conditions
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Pain

Intervention / Treatment
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* Other: Music intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy adults Exclusion Criteria: musicians with knowledge of music theory diagnosed and taking medication for chronic pain skin problems psychological or neurological pathologies

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CPT - LLM - MLM<br>On day 1: CPT On day 2: LLM On day 3: MLM | Other: Music intervention<br>* The cold pressor test will consist in the immersion of the participants' arm in 10 degrees circulating water for two minutes. The music sequences will be all 20 minutes, instrumental, professionally recorded in the studio and composed specifically for the Music Care application and are thus unfamiliar to participants. There will be two music conditions: the most-liked-music (MLM) and least-liked-music (LLM) conditions.<br>* Other names: Cold Pressor Test (CPT);|
| Experimental: CPT - MLM - LLM<br>On day 1: CPT On day 2: MLM On day 3: LLM | Other: Music intervention<br>* The cold pressor test will consist in the immersion of the participants' arm in 10 degrees circulating water for two minutes. The music sequences will be all 20 minutes, instrumental, professionally recorded in the studio and composed specifically for the Music Care application and are thus unfamiliar to participants. There will be two music conditions: the most-liked-music (MLM) and least-liked-music (LLM) conditions.<br>* Other names: Cold Pressor Test (CPT);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain level change from baseline to the end of music intervention | Pain level measured using a Computerized Visual Analogue Scale (VAS) from 0: no pain to 100: most intense pain tolerable. | Collected before the music starts (considered as baseline), and after the whole 20-minutes cycle. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain level change from baseline to the beginning of music intervention | Pain level measured using a Computerized Visual Analogue Scale (VAS) from 0: no pain to 100: most intense pain tolerable. | Collected before the music starts (considered as baseline) and 2.20 minutes after the music start. | 
| Pain level change from baseline to the relaxation phase of music intervention | Pain level measured using a Computerized Visual Analogue Scale (VAS) from 0: no pain to 100: most intense pain tolerable. | Collected before the music starts (considered as baseline) and after the relaxation phase at 11.30 minutes. | 
| Perception of time | Under both music conditions, the duration of the session will not be communicated to the participants. At the end of the musical intervention sequence, they will be asked how long it had lasted according to their opinion. | 20 minutes after music starts | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Anxiety, Musical intervention, Web app-based