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Completed

NCT Number: NCT06008951

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

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.

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Key information

Conditions

Pain Agnosia Analgesia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Erasmus Medical Center

Rotterdam, 3015 GD, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Listening to music

Other

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.

Listening to a podcast

Other

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.

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Markus Klimek

Other

Collaborators

  • Erasmus University Rotterdam

Registry information

Official study 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

Acronym: MOSART

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 24, 2023
Registry last updated
Jan 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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