Reduction of Thermal Pain From a Personalized Musical Intervention : Effect of Musical Preference
Condition: Pain
Study type: Interventional

Summary: 
      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: 
      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%.
    

Intervention name(s): Music intervention
Intervention type(s): Other
Intervention description(s): 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.
Other intervention name(s): Cold Pressor Test (CPT)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pain; Anxiety; Musical intervention; Web app-based