PainPainMusicNCT05267795
Reducing Pain With Focused Music Listening
A study testing Experimentally-induced pain in people with Pain, run by University of Bergen at 1 site in Norway.
Trial summary
Pain-reducing effects of music listening are well-established, but the effects are small and their clinical relevance questionable. Recent theoretical advances, however, have proposed that synchronizing to music, such as clapping, tapping or dancing, has evolutionarily important social effects that are associated with… Read more about this study
- Who is it for?
- Ages 19 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Experimentally-induced pain
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteNorway
- Study dates
- 22 Apr 2019to 30 Oct 2020
- 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 19 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 years or older
- Healthy
Who cannot join
- History of a psychiatric or neurological disease
- History of substance dependence
- use of any prescription drugs
- Hearing impairment
- Musical anhedonia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reducing Pain Thresholds Using a Focused Music Listening Technique
Pain-reducing effects of music listening are well-established, but the effects are small and their clinical relevance questionable. Recent theoretical advances, however, have proposed that synchronizing to music, such as clapping, tapping or dancing, has evolutionarily important social effects that are associated with activation of the endogenous opioid system (EOS; which supports both analgesia and social bonding). Thus, active sensorimotor synchronization to music could have stronger analgesic effects than simply listening to music. However, to the best of the investigators' knowledge, the hypothesis of an EOS activation by sensorimotor synchronization to music has never been investigated. Accordingly, the investigators set up a test with the premise that if sensorimotor synchronization to music indeed activates the EOS, then it should have larger pain-reducing effects than simply listening to music. Using pressure algometry to the fingernails, specific amounts of pain were delivered to healthy adults either during music listening or silence, while either performing an active tapping task or a passive control task. As the dependent variable, perceived pain was rated on a scale ranging from 1 to 9 (1 = very little, 5 = medium, 9 = very strong). In addition, to pain ratings, participants provided ratings of their emotional state in terms of pleasantness as well as arousal, and then rated their familiarity with the music (also on scales ranging from 1 to 9). Emotion ratings were obtained to explore whether the mechanisms driving pain-reducing effects of sensorimotor synchronization to music include emotion. At the end of the experiment, participants also rated their preference for the music on a scale ranging from 1 to 9 (see Method). Familiarity and preference ratings were obtained to elucidate possible contributions of these factors on pain reduction.
- Conditions
- Pain
- Being tested
- Experimentally-induced pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimentally-induced painBehavioural
Specific pain levels were applied on the participants' fingernails in each of 40 experimental trials using pressure algometry.
| Study group | Role | What they receive |
|---|---|---|
| Operationalization | Experimental | The experiment used a 2x2 within-subjects design in which participants either listened to music or underwent a silent control period and either performed an active foot tapping task, or a passive control task with no movement resulting in four experimental trial types: (a) Music Active (music with tapping); (b) Music Passive (music without tapping); (c) Silence Active (silence with tapping); and (d) Silence Passive (silence without tapping). The allocation of the music excerpts to the task (active, passive) was random, and the order of the four experimental trial types was counterbalanced. Receives: Behavioral: Experimentally-induced pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Pain
rated on a scale ranging from 1 to 9 (1 = very little, 5 = medium, 9 = very strong)
Measured: 40 minutes (duration of time over which each participant is assessed)
Emotional state with regard to felt pleasantness
rated on a scale ranging from 1 to 9 (1 = very uncomfortable, 5 = medium, 9 = very comfortable)
Measured: 40 minutes (duration of time over which each participant is assessed)
Emotional state with regard to felt arousal
rated on a scale ranging from 1 to 9 (1 = very calm, 5 = medium, 9 = very activated)
Measured: 40 minutes (duration of time over which each participant is assessed)
Familiarity with the music excerpt (only during trials with music)
rated on a scale ranging from 1 to 9 (1 = not at all, 5 = partially known, 9 = well known)
Measured: 40 minutes (duration of time over which each participant is assessed)
Preference ratings for each musical excerpt
rated on a scale ranging from 1 to 9 (1 = strongly disliked, 5 = medium, 9 = strongly liked)
Measured: 5 min (duration of time over which each participant is assessed)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2022
- Study start22 Apr 2019
- Primary completion30 Oct 2020
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The experiment used a 2x2 within-subjects design in which participants either listened to music or underwent a silent control period and either performed an active foot tapping task, or a passive control task with no movement resulting in four experimental trial types: (a) Music Active (music with tapping); (b) Music Passive (music without tapping); (c) Silence Active (silence with tapping); and (d) Silence Passive (silence without tapping). The allocation of the music excerpts to the task (active, passive) was random, and the order of the four experimental trial types was counterbalanced. Specific pain levels were applied on the participants' fingernails in each of 40 experimental trials using pressure algometry.
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Collaborators
- The Research Council of Norway
- Responsible party
- Sponsor
- Investigators
- Stefan Koelsch, PhD, Principal investigator, University of Bergen, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05267795
- Sponsor's protocol ID
- BFS Toppforsk
- Acronym
- PainMusic
- Status last verified
- Mar 2022
- First submitted
- 31 Jan 2022
- Last updated
- 4 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Werner LM, Skouras S, Bechtold L, Pallesen S, Koelsch S. Sensorimotor synchronization to music reduces pain. PLoS One. 2023 Jul 28;18(7):e0289302. doi: 10.1371/journal.pone.0289302. eCollection 2023.
PubMed 37506059
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Pain Thresholds Using a Focused Music Listening Technique
- ClinicalTrials.gov ID
- NCT05267795
- Acronym / sponsor ID
- PainMusic / BFS Toppforsk
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Collaborators
- The Research Council of Norway
- Study start
- 22 Apr 2019 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 4 Mar 2022 (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.
Pain-reducing effects of music listening are well-established, but the effects are small and their clinical relevance questionable. Recent theoretical advances, however, have proposed that synchronizing to music, such as clapping, tapping or dancing, has evolutionarily important social effects that are associated with activation of the endogenous opioid system (EOS; which supports both analgesia and social bonding). Thus, active sensorimotor synchronization to music could have stronger analgesic effects than simply listening to music. However, to the best of the investigators' knowledge, the hypothesis of an EOS activation by sensorimotor synchronization to music has never been investigated. Accordingly, the investigators set up a test with the premise that if sensorimotor synchronization to music indeed activates the EOS, then it should have larger pain-reducing effects than simply listening to music. Using pressure algometry to the fingernails, specific amounts of pain were delivered to healthy adults either during music listening or silence, while either performing an active tapping task or a passive control task. As the dependent variable, perceived pain was rated on a scale ranging from 1 to 9 (1 = very little, 5 = medium, 9 = very strong). In addition, to pain ratings, participants provided ratings of their emotional state in terms of pleasantness as well as arousal, and then rated their familiarity with the music (also on scales ranging from 1 to 9). Emotion ratings were obtained to explore whether the mechanisms driving pain-reducing effects of sensorimotor synchronization to music include emotion. At the end of the experiment, participants also rated their preference for the music on a scale ranging from 1 to 9 (see Method). Familiarity and preference ratings were obtained to elucidate possible contributions of these factors on pain reduction.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The experiment used a 2x2 within-subjects design in which participants either listened to music or underwent a silent control period and either performed an active foot tapping task, or a passive control task with no movement resulting in four experimental trial types: (a) Music Active (music with tapping); (b) Music Passive (music without tapping); (c) Silence Active (silence with tapping); and (d) Silence Passive (silence without tapping). The allocation of the music excerpts to the task (active, passive) was random, and the order of the four experimental trial types was counterbalanced. Specific pain levels were applied on the participants' fingernails in each of 40 experimental trials using pressure algometry.
| Arm | Type | Receives |
|---|---|---|
| Operationalization | Experimental | Behavioral: Experimentally-induced painThe experiment used a 2x2 within-subjects design in which participants either listened to music or underwent a silent control period and either performed an active foot tapping task, or a passive control task with no movement resulting in four experimental trial types: (a) Music Active (music with tapping); (b) Music Passive (music without tapping); (c) Silence Active (silence with tapping); and (d) Silence Passive (silence without tapping). The allocation of the music excerpts to the task (active, passive) was random, and the order of the four experimental trial types was counterbalanced. |
Who may qualify
- Ages
- 19 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 18 years or older
- Healthy
Key exclusion criteria (5 listed)
- History of a psychiatric or neurological disease
- History of substance dependence
- use of any prescription drugs
- Hearing impairment
- Musical anhedonia
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 |
|---|---|---|
| Experimentally-induced painSpecific pain levels were applied on the participants' fingernails in each of 40 experimental trials using pressure algometry. | Behavioural | Operationalization |
Primary outcome
Perceived Pain
Time frame: 40 minutes (duration of time over which each participant is assessed)
rated on a scale ranging from 1 to 9 (1 = very little, 5 = medium, 9 = very strong)
Emotional state with regard to felt pleasantness
Time frame: 40 minutes (duration of time over which each participant is assessed)
rated on a scale ranging from 1 to 9 (1 = very uncomfortable, 5 = medium, 9 = very comfortable)
Emotional state with regard to felt arousal
Time frame: 40 minutes (duration of time over which each participant is assessed)
rated on a scale ranging from 1 to 9 (1 = very calm, 5 = medium, 9 = very activated)
Familiarity with the music excerpt (only during trials with music)
Time frame: 40 minutes (duration of time over which each participant is assessed)
rated on a scale ranging from 1 to 9 (1 = not at all, 5 = partially known, 9 = well known)
Preference ratings for each musical excerpt
Time frame: 5 min (duration of time over which each participant is assessed)
rated on a scale ranging from 1 to 9 (1 = strongly disliked, 5 = medium, 9 = strongly liked)
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 4 Mar 2022.
- Derived from this study: PubMed 37506059Werner LM, Skouras S, Bechtold L, Pallesen S, Koelsch S. Sensorimotor synchronization to music reduces pain. PLoS One. 2023 Jul 28;18(7):e0289302. doi: 10.1371/journal.pone.0289302. eCollection 2023.
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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.
Stefan Koelsch, PhD principal investigator
University of Bergen, Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimentally-induced pain in people with Pain, run by University of Bergen at 1 site in Norway.
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 2 inclusion and 5 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 4 Mar 2022. 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 Norway. 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?
Perceived Pain (time frame: 40 minutes (duration of time over which each participant is assessed)). The study lists 5 primary outcomes in all. 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 NCT05267795, which also lists 1 linked publication.
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 4 Mar 2022.