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

Pain Clinical Trial

— MOSART  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06008951
• Other study ID #: NL84165.078.23
• Secondary ID: MEC-2023-0253
• Status: Recruiting
• Phase: N/A
• Start date: August 30, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: August 2023
• Source: Erasmus Medical Center
• Contact: Antonia S Becker, MD
• Phone: +31641188966
• Email: a.becker[@]erasmusmc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: December 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Analgesia
• Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
Netherlands	Erasmus Medical Center	Rotterdam

Sponsors (2)

Lead Sponsor	Collaborator
Markus Klimek	Erasmus University Rotterdam

Country where clinical trial is conducted

Netherlands, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pain intensity	Pain intensity will be measured using the Numeric Rating Scale. Values range from 0 to 10, with higher values indicating higher pain intensity.	Immediately after each increasing electric pain stimuli. Measured at the same day as the experiment
Secondary	Pain unpleasantness	Pain unpleasantness will be measured using the Numeric Rating Scale. Values range from 0 to 10, with higher values indicating higher pain unpleasantness.	Immediately after each increasing electric pain stimuli. Measured at the same day as the experiment.
Secondary	Heart rate variability (HRV)	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).	During the intervention. Measured at the same day as the experiment.
Secondary	Anxiety measured with State-Trait Anxiety Inventory (STAI)-6	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.	At baseline and immediately after each increasing electric pain stimuli. Measured at the same day as the experiment.
Secondary	Affective reaction measures with Self-Assessment Manikin (SAM)	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.	At baseline and immediately after each increasing electric pain stimuli. Measured at the same day as the experiment.
Secondary	Music listening Questionnaire	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.	Immediately after the completion of all interventions. Measured at the same day as the experiment.
Secondary	Music gernes and characteristics	The self-chosen and researcher-chosen music will be assessed and compared using the Spotify® Application Programming Interface (API).	Immediately after the completion of all interventions. Measured at the same day as the experiment.