The Influence of Music Choice on Pain Tolerance in the Context of Social Background (MOSART)

December 31, 2024 updated by: Markus Klimek

The Influence of Music Choice on Pain Tolerance in the Context of Social Background in Healthy Volunteers: the MOSART Trial - a Randomized Controlled Trial

This study will investigate the effect of different music on the pain tolerance during an increasing electric stimulus in healthy individuals, taking social background into account.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The implementation of music in health care settings has shown promising results in alleviating stress, anxiety, and pain-related outcomes. However, the heterogeneity in music selection and characteristics across clinical trials has made it difficult to draw direct comparisons between different music interventions. Additionally, the influence of social background on music perception remains largely unexplored, despite its potential significance. Therefore, a collaboration of medical and sociological experts propose a randomized controlled trial to investigate the effects of two different music interventions on pain tolerance, taking into account the participants' social backgrounds. The primary objective of this study is to assess the impact of self-chosen and researcher-chosen music compared to a control intervention (podcast) on pain tolerance among healthy female volunteers at the outpatient clinic of the Center of Pain Medicine, Erasmus Medical Center, Rotterdam.

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Rotterdam, Netherlands, 3015 GD
        • Erasmus Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Between 18 and 60 years of age
  • Female
  • Sufficient knowledge of the Dutch language to understand the study documents (in the judgement of the attending physician or researcher)
  • Provision of written informed consent by subject

Exclusion Criteria:

  • Significant hearing impairment
  • Current complaints of tinnitus
  • Current use of analgesic medication
  • Presence of acute or chronic pain
  • Current treatment by a medical specialist or general practitioner
  • History of cardiac disease of arrhythmias
  • (Suspected) pregnancy
  • Diagnosed psychiatric or neurological impairments
  • Electric implants (e.g. pacemakers)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Self-chosen music
The self-chosen music playlist will be assembled by the participant in advance.
Other: Listening to music
All participants will listen to self-chosen or researcher-chosen music with noise-cancelling headphones (JBL Tune 770NC). The music will be administered for 20 minutes before participants receive increasing electric pain stimuli.
Experimental: Researcher-chosen music
The researcher-chosen music playlists will primarily be composed by the Music as Medicine research group from Erasmus Medical Center, based on current expert opinion. The playlist will be created with the goal to help while experiencing pain based on previous literature.
Other: Listening to music
All participants will listen to self-chosen or researcher-chosen music with noise-cancelling headphones (JBL Tune 770NC). The music will be administered for 20 minutes before participants receive increasing electric pain stimuli.
Active Comparator: Podcast (control)
The choice of podcast will be based on expert opinion of the sociology department of the Erasmus University Rotterdam.
Other: Listening to a podcast
ln the control condition, participants will listen to a podcast with noise-cancelling headphones (JBL Tune 770NC). The podcast will be administered for 20 minutes before participants receive increasing electric pain stimuli.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain tolerance in amperage
Time Frame: During the intervention, after listening 20 minutes to the music/ podcast. Measured at the same day as the experiment.
The primary object of this study is the pain tolerance by increasing electric stimuli. The measurement will be performed after each intervention while participants are still listening to the music or podcast. Each measurement will be performed three times. Results will be reported in amperage and analyzed with an explorative approach looking at social background.
During the intervention, after listening 20 minutes to the music/ podcast. Measured at the same day as the experiment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity
Time Frame: Immediately after each increasing electric pain stimuli. Measured at the same day as the experiment
Pain intensity will be measured using the Numeric Rating Scale. Values range from 0 to 10, with higher values indicating higher pain intensity.
Immediately after each increasing electric pain stimuli. Measured at the same day as the experiment
Pain unpleasantness
Time Frame: Immediately after each increasing electric pain stimuli. Measured at the same day as the experiment.
Pain unpleasantness will be measured using the Numeric Rating Scale. Values range from 0 to 10, with higher values indicating higher pain unpleasantness.
Immediately after each increasing electric pain stimuli. Measured at the same day as the experiment.
Heart rate variability (HRV)
Time Frame: During the intervention. Measured at the same day as the experiment.
HRV, the variation in time between adjacent heartbeats, can be used as a marker for autonomic function. Furthermore, an increase of HRV has been found after music interventions, possibly due to the effect on the parasympatic nervous system. HRV will be measured continuously using an Acentas Chest Strap (BM innovations GmbH).
During the intervention. Measured at the same day as the experiment.
Anxiety measured with State-Trait Anxiety Inventory (STAI)-6
Time Frame: At baseline and immediately after each increasing electric pain stimuli. Measured at the same day as the experiment.
The STAI-6 questionnaire is a validated and frequently used questionnaire to assess anxiety. The questionnaire comprises six items and the total scores ranges from 20 to 80, with higher score indicating a higher level of anxiety.
At baseline and immediately after each increasing electric pain stimuli. Measured at the same day as the experiment.
Affective reaction measures with Self-Assessment Manikin (SAM)
Time Frame: At baseline and immediately after each increasing electric pain stimuli. Measured at the same day as the experiment.
The SAM is a non-verbal pictorial assessment technique that directly measures the pleasure, arousal, and dominance associated with a person's affective reaction to a wide variety of stimuli. Each measurement value ranges from 1 to 9, which indicates different levels of pleasure, arousal and dominance.
At baseline and immediately after each increasing electric pain stimuli. Measured at the same day as the experiment.
Music listening Questionnaire
Time Frame: Immediately after the completion of all interventions. Measured at the same day as the experiment.
This questionnaire will consist of four items. Participants will be asked to indicate which type of music they believe was the most and least effective for managing pain, and whether they have an explanation for this. Additionally, we will ask for their opinion of the podcast (control condition) and elaborate in which extend the podcast helped to alleviate the pain.
Immediately after the completion of all interventions. Measured at the same day as the experiment.
Music gernes and characteristics
Time Frame: Immediately after the completion of all interventions. Measured at the same day as the experiment.
The self-chosen and researcher-chosen music will be assessed and compared using the Spotify® Application Programming Interface (API).
Immediately after the completion of all interventions. Measured at the same day as the experiment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Markus Klimek

Collaborators

Erasmus University Rotterdam

Investigators

  • Principal Investigator: Markus Klimek, MD PhD, Erasmus Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 30, 2023

Primary Completion (Actual)

November 15, 2024

Study Completion (Actual)

November 15, 2024

Study Registration Dates

First Submitted

August 9, 2023

First Submitted That Met QC Criteria

August 23, 2023

First Posted (Actual)

August 24, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 31, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NL84165.078.23
  • MEC-2023-0253 (Other Identifier: Medisch Ethische Toetsings Commissie Erasmus MC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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