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

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ClinicalTrials.gov Identifier: NCT06008951
Recruitment Status : Recruiting
First Posted : August 24, 2023
Last Update Posted : September 7, 2023
Sponsor:
Collaborator:
Erasmus University Rotterdam
Information provided by (Responsible Party):
Markus Klimek, Erasmus Medical Center

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pain Analgesia Other: Listening to music Other: Listening to a podcast Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: This randomized controlled trial will have a Latin-square design and investigates the effect of self-chosen music and researcher-chosen music. Each participant will receive the same three interventions (self-chosen music, researcher-chosen music and control) in a randomized order. Listening to an informative podcast will serve as a control condition. During each intervention subjects will receive electric stimuli (experimental phase). The highest electric stimuli to tolerate (pain tolerance) will be detected. Each experimental phase will last 20 minutes and in between a wash-out period of 20 minutes will be completed.
Masking: None (Open Label)
Masking Description: Due to the nature of the study and the music intervention, it is not possible to blind participants and investigators. However, participants will not be informed of the study arm to which they are randomized in advance.
Primary Purpose: Basic Science
Official Title: The Influence of Music Choice on Pain Tolerance in the Context of Social Background in Healthy Volunteers: the MOSART Trial - A Randomized Controlled Trial
Actual Study Start Date : August 30, 2023
Estimated Primary Completion Date : August 31, 2024
Estimated Study Completion Date : December 31, 2024
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).

  4. 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.

  5. 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.

  6. 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.

  7. 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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06008951


Contacts
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Contact: Antonia S Becker, MD +31641188966 a.becker@erasmusmc.nl
Contact: Emy S van der Valk Bouman, MD +31646461901 e.vandervalkbouman@erasmusmc.nl

Locations
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Netherlands
Erasmus Medical Center Recruiting
Rotterdam, Netherlands, 3015 GD
Contact: Antonia S Becker, MD    +31641188966    a.becker@erasmusmc.nl   
Contact: Emy S van der Valk Bouman, MD    +31646461901    e.vandervalkbouman@erasmusmc.nl   
Principal Investigator: Markus Klimek, MD PhD         
Sub-Investigator: Julian Schaap, PhD         
Sub-Investigator: Koen van Eijck, PhD         
Sub-Investigator: Emy S van der Valk Boumann, MD         
Sub-Investigator: Antonia S Becker, MD         
Sponsors and Collaborators
Markus Klimek
Erasmus University Rotterdam
Investigators
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Principal Investigator: Markus Klimek, MD PhD Erasmus Medical Center
More Information
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Publications:
Roy WG, Dowd TJ. What Is Sociological about Music? Annual Review of Sociology. 2010;36(1):183-203.

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Responsible Party: Markus Klimek, Vice-Chairman / Director Residency Training Program, Department of Anesthesiology, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT06008951    
Other Study ID Numbers: NL84165.078.23
MEC-2023-0253 ( Other Identifier: Medisch Ethische Toetsings Commissie Erasmus MC )
First Posted: August 24, 2023    Key Record Dates
Last Update Posted: September 7, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Markus Klimek, Erasmus Medical Center:
music
pain
analgesia
 music-induced analgesia
socioeconomic status
cultural capital