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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%.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

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%.

Tipo de estudo

Intervencional

Inscrição (Real)

33

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

      • Sherbrooke, Canadá
        • Sherbrooke University Hospital Centre

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 45 anos (Adulto)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição cruzada
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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.

Outros nomes:
  • Cold Pressor Test (CPT)
Experimental: 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.

Outros nomes:
  • Cold Pressor Test (CPT)

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Pain level change from baseline to the end of music intervention
Prazo: 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.

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Pain level change from baseline to the beginning of music intervention
Prazo: 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
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de abril de 2021

Conclusão Primária (Real)

20 de maio de 2021

Conclusão do estudo (Real)

20 de maio de 2021

Datas de inscrição no estudo

Enviado pela primeira vez

16 de abril de 2021

Enviado pela primeira vez que atendeu aos critérios de CQ

26 de abril de 2021

Primeira postagem (Real)

28 de abril de 2021

Atualizações de registro de estudo

Última Atualização Postada (Real)

3 de março de 2022

Última atualização enviada que atendeu aos critérios de controle de qualidade

15 de fevereiro de 2022

Última verificação

1 de fevereiro de 2022

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • MUSEC

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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