Clinical trial NCT06008951: The Influence of Music Choice on Pain Tolerance in the Context of Social Background
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Analgesia
Keywords: music
pain
analgesia
music-induced analgesia
socioeconomic status
cultural capital
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: Erasmus University Rotterdam
First posted: 2023-08-24
Enrollment: 84
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility 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)

Primary outcomes:
measure: Pain tolerance in amperage
timeFrame: During the intervention, after listening 20 minutes to the music/ podcast. Measured at the same day as the experiment.
Secondary outcomes:
measure: Pain intensity
timeFrame: Immediately after each increasing electric pain stimuli. Measured at the same day as the experiment
measure: Pain unpleasantness
timeFrame: Immediately after each increasing electric pain stimuli. Measured at the same day as the experiment.
measure: Heart rate variability (HRV)
timeFrame: During the intervention. Measured at the same day as the experiment.
measure: Anxiety measured with State-Trait Anxiety Inventory (STAI)-6
timeFrame: At baseline and immediately after each increasing electric pain stimuli. Measured at the same day as the experiment.
measure: Affective reaction measures with Self-Assessment Manikin (SAM)
timeFrame: At baseline and immediately after each increasing electric pain stimuli. Measured at the same day as the experiment.
measure: Music listening Questionnaire
timeFrame: Immediately after the completion of all interventions. Measured at the same day as the experiment.
measure: Music gernes and characteristics
timeFrame: Immediately after the completion of all interventions. Measured at the same day as the experiment.
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
Study officials:
affiliation: Erasmus Medical Center
name: Markus Klimek, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kuhlmann AYR, de Rooij A, Kroese LF, van Dijk M, Hunink MGM, Jeekel J. Meta-analysis evaluating music interventions for anxiety and pain in surgery. Br J Surg. 2018 Jun;105(7):773-783. doi: 10.1002/bjs.10853. Epub 2018 Apr 17.
citation: Lunde SJ, Vuust P, Garza-Villarreal EA, Vase L. Music-induced analgesia: how does music relieve pain? Pain. 2019 May;160(5):989-993. doi: 10.1097/j.pain.0000000000001452. No abstract available.
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citation: Mojtabavi H, Saghazadeh A, Valenti VE, Rezaei N. Can music influence cardiac autonomic system? A systematic review and narrative synthesis to evaluate its impact on heart rate variability. Complement Ther Clin Pract. 2020 May;39:101162. doi: 10.1016/j.ctcp.2020.101162. Epub 2020 Apr 7.
citation: de Witte M, Spruit A, van Hooren S, Moonen X, Stams GJ. Effects of music interventions on stress-related outcomes: a systematic review and two meta-analyses. Health Psychol Rev. 2020 Jun;14(2):294-324. doi: 10.1080/17437199.2019.1627897. Epub 2019 Jul 15.
citation: Bradt J, Dileo C, Shim M. Music interventions for preoperative anxiety. Cochrane Database Syst Rev. 2013 Jun 6;2013(6):CD006908. doi: 10.1002/14651858.CD006908.pub2.
citation: Martin-Saavedra JS, Vergara-Mendez LD, Pradilla I, Velez-van-Meerbeke A, Talero-Gutierrez C. Standardizing music characteristics for the management of pain: A systematic review and meta-analysis of clinical trials. Complement Ther Med. 2018 Dec;41:81-89. doi: 10.1016/j.ctim.2018.07.008. Epub 2018 Jul 11.