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

NCT ID: NCT06008951

Last Updated: 2025-01-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-30

Study Completion Date

2024-11-15

Brief Summary

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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

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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.

Conditions

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Pain Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

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.

Study Groups

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Self-chosen music

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

Group Type EXPERIMENTAL

Listening to music

Intervention Type 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

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.

Group Type EXPERIMENTAL

Listening to music

Intervention Type 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.

Podcast (control)

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

Group Type ACTIVE_COMPARATOR

Listening to a podcast

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Erasmus University Rotterdam

OTHER

Sponsor Role collaborator

Markus Klimek

OTHER

Sponsor Role lead

Responsible Party

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Markus Klimek

Vice-Chairman / Director Residency Training Program, Department of Anesthesiology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Markus Klimek, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Erasmus Medical Center

Locations

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Erasmus Medical Center

Rotterdam, , Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type BACKGROUND
PMID: 29665028 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30507782 (View on PubMed)

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 32379689 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31167611 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23740695 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30477868 (View on PubMed)

Other Identifiers

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MEC-2023-0253

Identifier Type: OTHER

Identifier Source: secondary_id

NL84165.078.23

Identifier Type: -

Identifier Source: org_study_id

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