Pain, AcuteDOMINANTNCT06286137
Duration of Music Interventions and Pain Tolerance (DOMINANT)
A study testing Listening to music for 1 minute, Listening to music for 5 minutes and Listening to music for 20 minutes in people with Pain, Acute, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
This study will investigate the effect of different durations of music interventions (1, 5 and 20 minutes of music) on pain tolerance. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Acute
- What is being tested?
- Listening to music for 1 minute, Listening to music for 5 minutes and Listening to music for 20 minutes
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteNetherlands
- Study dates
- 28 Feb 2024to 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between 18 and 64 years of age
- 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
- History of cardiac disease or arrhythmias
- Current treatment by a medical specialist or general practitioner
- Professional musician or singer (practicing in average >1 hour each day)
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Duration of Music Interventions and PAiN Tolerance in Healthy Individuals: the DOMINANT Trial
This study will investigate the effect of different durations of music interventions (1, 5 and 20 minutes of music) on pain tolerance.
Read the detailed description
Music interventions reduce perioperative pain and anxiety. However, it is yet unclear how long music needs to be presented in order to have an effect. Therefore, the investigators would like to propose a pilot randomized controlled trial in order to investigate the optimal duration of musical interventions. The main objective of this study is to investigate the effect of different durations of music interventions on pain tolerance (expressed in amperage). Secondary objectives are to investigate the effects of music duration on heart rate variability (expressed in milliseconds) and subjective measurements of emotions, anxiety and pain. Healthy volunteers (age ≥18 years) will be included, and the study will take place at the outpatient clinic of the Center of Pain Medicine, Erasmus Medical Center, Rotterdam.
- Conditions
- Pain, Acute
- Being tested
- Listening to music for 1 minute, Listening to music for 5 minutes, Listening to music for 20 minutes, Not listening to music
- Keywords
- Music-induced analgesia
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Listening to music for 1 minuteOther
Participants will be instructed to make a 20-minute playlist with their own preferred music, using a tablet and a music listening app. That playlist will then be presented on shuffle mode for 1 minute through headphones provided by the hospital. Volume can be selected by the participants. However, in order to prevent hearing loss the volume cannot exceed 80 decibels. The 19 minutes before the 1 minute music listening intervention, participants will be instructed to remain seated and are not allowed to do anything else (for example using their phones).
Listening to music for 5 minutesOther
Participants will be instructed to make a 20-minute playlist with their own preferred music, using a tablet and a music listening app. That playlist will then be presented on shuffle mode for 1 minute through headphones provided by the hospital. Volume can be selected by the participants. However, in order to prevent hearing loss the volume cannot exceed 80 decibels. The 15 minutes before the 5 minutes music listening intervention, participants will be instructed to remain seated and are not allowed to do anything else (for example using their phones).
Listening to music for 20 minutesOther
Participants will be instructed to make a 20-minute playlist with their own preferred music, using a tablet and a music listening app. That playlist will then be presented on shuffle mode for 20 minutes through headphones provided by the hospital. Volume can be selected by the participants. However, in order to prevent hearing loss the volume cannot exceed 80 decibels.
Not listening to musicOther
Participants will be instructed to remain seated and are not allowed to do anything else (for example using their phones), for a duration of 20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | The control group will be seated for 20 minutes without doing anything else, and not listen to music. Receives: Other: Not listening to music |
| 1 minute music group | Experimental | The 1 minute music group will be seated for 19 minutes without doing anything else, and listen to music for 1 minute. Receives: Other: Listening to music for 1 minute |
| 5 minutes music group | Experimental | The 5 minutes music group will be seated for 15 minutes without doing anything else, and listen to music for 5 minutes. Receives: Other: Listening to music for 5 minutes |
| 20 minutes music group | Experimental | The 20 minutes music group will listen to music for 20 minutes. Receives: Other: Listening to music for 20 minutes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain tolerance
The primary objective of the study is the pain tolerance. This tolerance will be measured using electric stimuli directly after the 20 minutes of listening to music or sitting in silence. Each measurement will be performed three times. Results will be expressed in amperage.
Measured: At the end of the intervention, after the 20 minutes of listening to music or sitting in silence. Measured at the same day as the experiment.
Secondary outcomes (6)
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 20 minutes of listening to music or sitting in silence, and during the eletric stimuli directly after those 20 minutes. Measured at the same day as the experiment.
Level of perceived anxiety, Spielberger State-Trait Anxiety Inventory (STAI)-6 questionnaire
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 a higher score indicating a higher level of anxiety.
Measured: At baseline and immediately after the intervention, after the electric stimuli. Measured at the same day as the experiment.
Valence and arousal, Self-Assessment manikin (SAM) questionnaire
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 the intervention, after the electric stimuli. Measured at the same day as the experiment.
Music listening Questionnaire
This questionnaire will consist of 7 open questions about music importance and music listening behavior. Participants will be asked to what extend they are a lover of music from a scale of 1 to 7, where a higher value is a higher amout of loving music. Next, participants will be asked how many minutes per day they listen actively and passively to music. Finally, participants will be asked in open questions about their favorite genres, their favorite moments of listening to music, if they play an instrument and if there is music that they dislike.
Measured: At baseline. Measured at the same day as the experiment.
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: At the end of the intervention, immediately after each electric stimulus. 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: At the end of the intervention, immediately after each electric stimulus. 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 posted29 Feb 2024
- Study start28 Feb 2024
- 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 (8)Papers the sponsor has linked to this study.
- Other trials for Pain, AcuteStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The randomized controlled trial will have four study arms. Subjects will be assigned to one of the four arms: control without music and music groups with 1 minute, 5 minutes and 20 minutes. All subjects will receive electric stimuli in three phases. In each phase, subject will be exposed to three consecutive stimuli. First a detection threshold will be measured. Secondly a baseline test will be performed in order to assess basic levels of pain endurance. Hereafter, the intervention phase starts. Subjects in the music groups will listen to 1, 5 and 20 minutes of their own preferred music through headphones. Directly after, all subjects will again receive three electric stimuli.
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Markus Klimek, Erasmus Medical Center
- Investigators
- Markus Klimek, MD PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06286137
- Sponsor's protocol ID
- NL82922.078.22
- Acronym
- DOMINANT
- Status last verified
- Dec 2024
- First submitted
- 15 Feb 2024
- Last updated
- 1 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will only be shared upon request. This decision will be made by the principal investigator.
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 29665028Fu VX, Oomens P, Klimek M, Verhofstad MHJ, Jeekel J. The Effect of Perioperative Music on Medication Requirement and Hospital Length of Stay: A Meta-analysis. Ann Surg. 2020 Dec;272(6):961-972. doi: 10.1097/SLA.0000000000003506.
PubMed 31356272Koelsch S. Brain correlates of music-evoked emotions. Nat Rev Neurosci. 2014 Mar;15(3):170-80. doi: 10.1038/nrn3666.
PubMed 24552785Basinski K, Zdun-Ryzewska A, Greenberg DM, Majkowicz M. Preferred musical attribute dimensions underlie individual differences in music-induced analgesia. Sci Rep. 2021 Apr 21;11(1):8622. doi: 10.1038/s41598-021-87943-z.
PubMed 33883585Valevicius D, Lepine Lopez A, Diushekeeva A, Lee AC, Roy M. Emotional responses to favorite and relaxing music predict music-induced hypoalgesia. Front Pain Res (Lausanne). 2023 Oct 25;4:1210572. doi: 10.3389/fpain.2023.1210572. eCollection 2023.
PubMed 38028433Howlin C, Stapleton A, Rooney B. Tune out pain: Agency and active engagement predict decreases in pain intensity after music listening. PLoS One. 2022 Aug 3;17(8):e0271329. doi: 10.1371/journal.pone.0271329. eCollection 2022.
PubMed 35921262Martin-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 30477868Lunde 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 30507782
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
- Duration of Music Interventions and PAiN Tolerance in Healthy Individuals: the DOMINANT Trial
- ClinicalTrials.gov ID
- NCT06286137
- Acronym / sponsor ID
- DOMINANT / NL82922.078.22
- Conditions
- Pain, Acute
- Keywords
- Music-induced analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 28 Feb 2024 (actual)
- Primary completion
- 15 Nov 2024 (actual)
- Study completion
- 15 Nov 2024 (actual)
- First posted
- 29 Feb 2024 (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 durations of music interventions (1, 5 and 20 minutes of music) on pain tolerance.
Detailed description
Music interventions reduce perioperative pain and anxiety. However, it is yet unclear how long music needs to be presented in order to have an effect. Therefore, the investigators would like to propose a pilot randomized controlled trial in order to investigate the optimal duration of musical interventions. The main objective of this study is to investigate the effect of different durations of music interventions on pain tolerance (expressed in amperage). Secondary objectives are to investigate the effects of music duration on heart rate variability (expressed in milliseconds) and subjective measurements of emotions, anxiety and pain. Healthy volunteers (age ≥18 years) will be included, and the study will take place at the outpatient clinic of the Center of Pain Medicine, Erasmus Medical Center, Rotterdam.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- The randomized controlled trial will have four study arms. Subjects will be assigned to one of the four arms: control without music and music groups with 1 minute, 5 minutes and 20 minutes. All subjects will receive electric stimuli in three phases. In each phase, subject will be exposed to three consecutive stimuli. First a detection threshold will be measured. Secondly a baseline test will be performed in order to assess basic levels of pain endurance. Hereafter, the intervention phase starts. Subjects in the music groups will listen to 1, 5 and 20 minutes of their own preferred music through headphones. Directly after, all subjects will again receive three electric stimuli.
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Not listening to musicThe control group will be seated for 20 minutes without doing anything else, and not listen to music. |
| 1 minute music group | Experimental | Other: Listening to music for 1 minuteThe 1 minute music group will be seated for 19 minutes without doing anything else, and listen to music for 1 minute. |
| 5 minutes music group | Experimental | Other: Listening to music for 5 minutesThe 5 minutes music group will be seated for 15 minutes without doing anything else, and listen to music for 5 minutes. |
| 20 minutes music group | Experimental | Other: Listening to music for 20 minutesThe 20 minutes music group will listen to music for 20 minutes. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Between 18 and 64 years of age
- 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 (8 listed)
- Significant hearing impairment
- Current complaints of tinnitus
- Current use of analgesic medication
- Presence of acute or chronic pain
- History of cardiac disease or arrhythmias
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 music for 1 minuteParticipants will be instructed to make a 20-minute playlist with their own preferred music, using a tablet and a music listening app. That playlist will then be presented on shuffle mode for 1 minute through headphones provided by the hospital. Volume can be selected by the participants. However, in order to prevent hearing loss the volume cannot exceed 80 decibels. The 19 minutes before the 1 minute music listening intervention, participants will be instructed to remain seated and are not allowed to do anything else (for example using their phones). | Other | 1 minute music group |
| Listening to music for 5 minutesParticipants will be instructed to make a 20-minute playlist with their own preferred music, using a tablet and a music listening app. That playlist will then be presented on shuffle mode for 1 minute through headphones provided by the hospital. Volume can be selected by the participants. However, in order to prevent hearing loss the volume cannot exceed 80 decibels. The 15 minutes before the 5 minutes music listening intervention, participants will be instructed to remain seated and are not allowed to do anything else (for example using their phones). | Other | 5 minutes music group |
| Listening to music for 20 minutesParticipants will be instructed to make a 20-minute playlist with their own preferred music, using a tablet and a music listening app. That playlist will then be presented on shuffle mode for 20 minutes through headphones provided by the hospital. Volume can be selected by the participants. However, in order to prevent hearing loss the volume cannot exceed 80 decibels. | Other | 20 minutes music group |
| Not listening to musicParticipants will be instructed to remain seated and are not allowed to do anything else (for example using their phones), for a duration of 20 minutes. | Other | Control group |
Primary outcome
Pain tolerance
Time frame: At the end of the intervention, after the 20 minutes of listening to music or sitting in silence. Measured at the same day as the experiment.
The primary objective of the study is the pain tolerance. This tolerance will be measured using electric stimuli directly after the 20 minutes of listening to music or sitting in silence. Each measurement will be performed three times. Results will be expressed in amperage.
6 secondary outcomes
Heart rate variability (HRV)
Time frame: During the 20 minutes of listening to music or sitting in silence, and during the eletric stimuli directly after those 20 minutes. Measured at the same day as the experiment.
Level of perceived anxiety, Spielberger State-Trait Anxiety Inventory (STAI)-6 questionnaire
Time frame: At baseline and immediately after the intervention, after the electric stimuli. Measured at the same day as the experiment.
Valence and arousal, Self-Assessment manikin (SAM) questionnaire
Time frame: At baseline and immediately after the intervention, after the electric stimuli. Measured at the same day as the experiment.
Music listening Questionnaire
Time frame: At baseline. Measured at the same day as the experiment.
Pain intensity
Time frame: At the end of the intervention, immediately after each electric stimulus. Measured at the same day as the experiment.
Pain unpleasantness
Time frame: At the end of the intervention, immediately after each electric stimulus. 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 31356272Fu VX, Oomens P, Klimek M, Verhofstad MHJ, Jeekel J. The Effect of Perioperative Music on Medication Requirement and Hospital Length of Stay: A Meta-analysis. Ann Surg. 2020 Dec;272(6):961-972. doi: 10.1097/SLA.0000000000003506.
- Background: PubMed 24552785Koelsch S. Brain correlates of music-evoked emotions. Nat Rev Neurosci. 2014 Mar;15(3):170-80. doi: 10.1038/nrn3666.
- Background: PubMed 33883585Basinski K, Zdun-Ryzewska A, Greenberg DM, Majkowicz M. Preferred musical attribute dimensions underlie individual differences in music-induced analgesia. Sci Rep. 2021 Apr 21;11(1):8622. doi: 10.1038/s41598-021-87943-z.
- Background: PubMed 38028433Valevicius D, Lepine Lopez A, Diushekeeva A, Lee AC, Roy M. Emotional responses to favorite and relaxing music predict music-induced hypoalgesia. Front Pain Res (Lausanne). 2023 Oct 25;4:1210572. doi: 10.3389/fpain.2023.1210572. eCollection 2023.
- Background: PubMed 35921262Howlin C, Stapleton A, Rooney B. Tune out pain: Agency and active engagement predict decreases in pain intensity after music listening. PLoS One. 2022 Aug 3;17(8):e0271329. doi: 10.1371/journal.pone.0271329. eCollection 2022.
- 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.
- 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.
- Individual participant dataSharing planned: No. Data will only be shared upon request. This decision will be made by the principal investigator.
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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 for 1 minute, Listening to music for 5 minutes and Listening to music for 20 minutes in people with Pain, Acute, run by Erasmus Medical Center 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 3 inclusion and 8 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 (time frame: At the end of the intervention, after the 20 minutes of listening to music or sitting in silence. 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 NCT06286137, which also lists 8 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.