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

NCT06008951 | Completed

• 2 other identifiers: NL84165.078.23MEC-2023-0253
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Analgesia

Keywords

music; pain; analgesia; music-induced analgesia; socioeconomic status; cultural capital

Outcome Measures

Primary Outcomes (1)

• Pain tolerance in amperage

  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 Outcomes (7)

• Pain intensity

  Immediately after each increasing electric pain stimuli. Measured at the same day as the experiment

• Pain unpleasantness

  Immediately after each increasing electric pain stimuli. Measured at the same day as the experiment.

• Heart rate variability (HRV)

  During the intervention. Measured at the same day as the experiment.

• Anxiety measured with State-Trait Anxiety Inventory (STAI)-6

  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)

  At baseline and immediately after each increasing electric pain stimuli. Measured at the same day as the experiment.

Study Arms (3)

Self-chosen music

EXPERIMENTAL

The self-chosen music playlist will be assembled by the participant in advance.

Other: Listening to music

Researcher-chosen music

EXPERIMENTAL

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

Podcast (control)

ACTIVE COMPARATOR

The choice of podcast will be based on expert opinion of the sociology department of the Erasmus University Rotterdam.

Other: Listening to a podcast

Interventions

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.

Researcher-chosen music; Self-chosen music

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.

Podcast (control)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Markus Klimek: lead
• Erasmus University Rotterdam: collaborator

Study Sites (1)

Erasmus Medical Center

Rotterdam, 3015 GD, Netherlands

Location

Related Publications (7)

• 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.

  PMID: 29665028 BACKGROUND

• 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.

  PMID: 30507782 BACKGROUND

• Roy WG, Dowd TJ. What Is Sociological about Music? Annual Review of Sociology. 2010;36(1):183-203.

  BACKGROUND

• 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.

  PMID: 32379689 BACKGROUND

• 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.

  PMID: 31167611 BACKGROUND

• 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.

  PMID: 23740695 BACKGROUND

• 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.

  PMID: 30477868 BACKGROUND

MeSH Terms

Conditions

Pain; Agnosia

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Markus Klimek, MD PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vice-Chairman / Director Residency Training Program, Department of Anesthesiology

Model Details: 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.

Study Record Dates

• First Submitted: August 9, 2023
• First Posted: August 24, 2023
• Study Start: August 30, 2023
• Primary Completion: November 15, 2024
• Study Completion: November 15, 2024
• Last Updated: January 1, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)