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

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%.

A tanulmány áttekintése

Állapot

Befejezve

Körülmények

Beavatkozás / kezelés

Részletes leírás

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%.

Tanulmány típusa

Beavatkozó

Beiratkozás (Tényleges)

33

Fázis

  • Nem alkalmazható

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi helyek

      • Sherbrooke, Kanada
        • Sherbrooke University Hospital Centre

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

18 év (Felnőtt)

Egészséges önkénteseket fogad

Igen

Tanulmányozható nemek

Összes

Leírás

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

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

  • Elsődleges cél: Kezelés
  • Kiosztás: Véletlenszerűsített
  • Beavatkozó modell: Crossover kiosztás
  • Maszkolás: Nincs (Open Label)

Fegyverek és beavatkozások

Résztvevő csoport / kar
Beavatkozás / kezelés
Kísérleti: CPT - LLM - MLM
On day 1: CPT On day 2: LLM On day 3: MLM

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.

Más nevek:
  • Cold Pressor Test (CPT)
Kísérleti: CPT - MLM - LLM
On day 1: CPT On day 2: MLM On day 3: LLM

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.

Más nevek:
  • Cold Pressor Test (CPT)

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Pain level change from baseline to the end of music intervention
Időkeret: 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".
Collected before the music starts (considered as baseline), and after the whole 20-minutes cycle.

Másodlagos eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Pain level change from baseline to the beginning of music intervention
Időkeret: Collected before the music starts (considered as baseline) and 2.20 minutes after the music start.
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
Időkeret: Collected before the music starts (considered as baseline) and after the relaxation phase at 11.30 minutes.
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
Időkeret: 20 minutes after music starts
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

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete (Tényleges)

2021. április 1.

Elsődleges befejezés (Tényleges)

2021. május 20.

A tanulmány befejezése (Tényleges)

2021. május 20.

Tanulmányi regisztráció dátumai

Először benyújtva

2021. április 16.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2021. április 26.

Első közzététel (Tényleges)

2021. április 28.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)

2022. március 3.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2022. február 15.

Utolsó ellenőrzés

2022. február 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

Egyéb vizsgálati azonosító számok

  • MUSEC

Terv az egyéni résztvevői adatokhoz (IPD)

Tervezi megosztani az egyéni résztvevői adatokat (IPD)?

NEM

Gyógyszer- és eszközinformációk, tanulmányi dokumentumok

Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz

Nem

Egy amerikai FDA által szabályozott eszközterméket tanulmányoz

Nem

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