PainMOSARTNCT06008951
The Influence of Music Choice on Pain Tolerance in the Context of Social Background
A study testing Listening to music and Listening to a podcast in people with Pain and Analgesia, run by Markus Klimek at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- What is being tested?
- Listening to music and Listening to a podcast
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteNetherlands
- Study dates
- 30 Aug 2023to 15 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- (Suspected) pregnancy
- Diagnosed psychiatric or neurological impairments
- Electric implants (e.g. pacemakers)
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- Listening to music, Listening to a podcast
- Keywords
- music, pain, analgesia, music-induced analgesia, socioeconomic status, cultural capital
- Medical subject headings
- Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Listening to musicOther
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 podcastOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Self-chosen music | Experimental | The self-chosen music playlist will be assembled by the participant in advance. Receives: 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. Receives: 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. Receives: Other: Listening to a podcast |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the intervention, after listening 20 minutes to the music/ podcast. Measured at the same day as the experiment.
Secondary outcomes (7)
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.
Measured: Immediately after each increasing electric pain stimuli. Measured at the same day as the experiment
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.
Measured: Immediately after each increasing electric pain stimuli. Measured at the same day as the experiment.
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).
Measured: During the intervention. Measured at the same day as the experiment.
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.
Measured: 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)
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.
Measured: At baseline and immediately after each increasing electric pain stimuli. Measured at the same day as the experiment.
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.
Measured: Immediately after the completion of all interventions. Measured at the same day as the experiment.
Music gernes and characteristics
The self-chosen and researcher-chosen music will be assessed and compared using the Spotify® Application Programming Interface (API).
Measured: Immediately after the completion of all interventions. Measured at the same day as the experiment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study start30 Aug 2023
- Primary completion15 Nov 2024
- Study completion15 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Markus Klimek
- Sponsor type
- University, hospital or other
- Collaborators
- Erasmus University Rotterdam
- Responsible party
- Sponsor-investigator, Markus Klimek, Erasmus Medical Center
- Investigators
- Markus Klimek, MD PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06008951
- Sponsor's protocol ID
- NL84165.078.23
- Other IDs
- MEC-2023-0253
- Acronym
- MOSART
- Status last verified
- Dec 2024
- First submitted
- 9 Aug 2023
- Last updated
- 1 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29665028Lunde 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.
PubMed 30507782Roy WG, Dowd TJ. What Is Sociological about Music? Annual Review of Sociology. 2010;36(1):183-203.
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.
PubMed 32379689de 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.
PubMed 31167611Bradt 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.
PubMed 23740695Martin-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.
PubMed 30477868
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06008951
- Acronym / sponsor ID
- MOSART / NL84165.078.23
- Keywords
- music, pain, analgesia, music-induced analgesia, socioeconomic status, cultural capital
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Markus KlimekUniversity, hospital or other
- Collaborators
- Erasmus University Rotterdam
- Study start
- 30 Aug 2023 (actual)
- Primary completion
- 15 Nov 2024 (actual)
- Study completion
- 15 Nov 2024 (actual)
- First posted
- 24 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Self-chosen music | Experimental | Other: Listening to musicThe self-chosen music playlist will be assembled by the participant in advance. |
| Researcher-chosen music | Experimental | Other: Listening to musicThe 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. |
| Podcast (control) | Active comparator | Other: Listening to a podcastThe choice of podcast will be based on expert opinion of the sociology department of the Erasmus University Rotterdam. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Listening to musicAll 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. | Other | Researcher-chosen music, Self-chosen music |
| Listening to a podcastln 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. | Other | Podcast (control) |
Primary outcome
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.
7 secondary outcomes
Pain intensity
Time frame: Immediately after each increasing electric pain stimuli. Measured at the same day as the experiment
Pain unpleasantness
Time frame: Immediately after each increasing electric pain stimuli. Measured at the same day as the experiment.
Heart rate variability (HRV)
Time frame: During the intervention. Measured at the same day as the experiment.
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.
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.
Music listening Questionnaire
Time frame: Immediately after the completion of all interventions. Measured at the same day as the experiment.
Music gernes and characteristics
Time frame: Immediately after the completion of all interventions. Measured at the same day as the experiment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2025.
- Background: PubMed 29665028Kuhlmann 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.
- Background: PubMed 30507782Lunde 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.
- BackgroundRoy WG, Dowd TJ. What Is Sociological about Music? Annual Review of Sociology. 2010;36(1):183-203.
- Background: PubMed 32379689Mojtabavi 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.
- Background: PubMed 31167611de 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.
- Background: PubMed 23740695Bradt 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.
- Background: PubMed 30477868Martin-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Markus Klimek, MD PhD principal investigator
Erasmus Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Listening to music and Listening to a podcast in people with Pain and Analgesia, run by Markus Klimek at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06008951, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jan 2025.