NCT04862832

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

Completed NA Last updated 3 March 2022

What this trial tests

NA trial testing Music intervention in Pain in 33 participants. Completed in 20 May 2021.

Timeline

1 April 2021

Primary endpoint
20 May 2021

20 May 2021

Quick facts

Lead sponsor	Association de Musicothérapie Applications et Recherches Cliniques
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	33
Start date	1 April 2021
Primary completion	20 May 2021
Estimated completion	20 May 2021
Sites	1 location across Canada

Drugs / interventions tested

• Music intervention — full drug profile →

Conditions studied

• Pain — all drugs for Pain →

Sponsor

Association de Musicothérapie Applications et Recherches Cliniques

Who can join

Adults 18 to 45, any sex, with Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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%.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A web app-based music intervention reduces experimental thermal pain: A randomized trial on preferred versus least-liked music style.
   Soyeux O, Marchand S. · · 2022 · cited 3× · PMID 36726374 · DOI 10.3389/fpain.2022.1055259