Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04862832 |
| Other study ID # |
MUSEC |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2021 |
| Est. completion date |
May 20, 2021 |
Study information
| Verified date |
February 2022 |
| Source |
Association de Musicothérapie Applications et Recherches Cliniques |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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%.
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%.
