PainPainMusic2NCT06960226
Replication Study: Reducing Pain With Focused Music Listening
A study testing Music Listening and Active Sensorimotor Synchronization in people with Pain and Pain Management, run by University of Bergen at 1 site in Norway.
Trial summary
The goal of this clinical trial is to confirm previous findings that actively tapping along to music can reduce pain more than just listening to music. This study aims to replicate the findings of a previous study (NCT05267795), with one change in how mild pain is created for the experiment. Read more about this study
- Who is it for?
- Ages 19 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Pain Management, Pain Threshold
- What is being tested?
- Music Listening and Active Sensorimotor Synchronization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteNorway
- Study dates
- 1 Mar 2025to 20 Apr 2025
- 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
- Age 18 years or older
- Self-reported good general health
- Able to understand study procedures and provide informed consent
- Normal or corrected-to-normal hearing (sufficient for music perception)
Who cannot join
- Contraindications for Electrical Stimulation:
- Presence of active electronic implants (e.g., cardiac pacemaker, cochlear implant)
- Pregnancy (self-reported)
- History of Epilepsy or seizure disorder
- Presence of local malignancy (especially near the stimulation site on forearm)
- Broken skin, wounds, or significant skin conditions on the right forearm (stimulation site)
Show all 16Show fewer
- Medical/Neurological History:
- History of significant psychiatric or neurological disease (other than epilepsy, listed above)
- History of substance dependence
- Current diagnosis of a chronic pain condition
- Medication Use:
- Current regular use of prescription analgesic (pain-relief) medication
- Current regular use of psychoactive medication
- Study-Specific:
- Self-reported musical anhedonia (inability to derive pleasure from music)
- Significant hearing impairment preventing clear perception of the music
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reducing Pain Thresholds Using a Focused Music Listening Technique
The goal of this clinical trial is to confirm previous findings that actively tapping along to music can reduce pain more than just listening to music. This study aims to replicate the findings of a previous study (NCT05267795), with one change in how mild pain is created for the experiment. This study involves healthy adults.
The main questions the study aims to answer are:
Read more
- Does actively tapping along to music lower feelings of pain compared to just listening to music?
- Does actively tapping along to music lower feelings of pain compared to being in silence (with or without tapping)?
- Is this method of using music and tapping helpful for managing pain?
Researchers will compare the amount of pain participants feel in four different situations:
- Listening to music while actively tapping their foot along with it.
- Just listening to music while resting their foot.
- Actively tapping their foot in silence.
- Sitting in silence while resting their foot.
Participants in this study will:
Experience brief moments of mild pain on their forearm. This pain is safely created using a small electrical pulse from a device held gently on the skin by the researcher. (This replaces the pressure method used in the original study).
Sometimes listen to music through headphones, and sometimes sit in silence. Sometimes tap their foot along to the music or a beat, and sometimes rest their foot. Rate how much pain they feel on a number scale after each pain pulse. Answer short questions about their mood during the experiment. Answer questions about how familiar they are with the music and how much they liked it at the end.
Read the detailed description
This study is a pre-registered replication of a previous trial (NCT05267795) investigating the analgesic effects of sensorimotor synchronization to music. While music listening alone has shown small, albeit reliable, pain-reducing effects, recent theories propose that active synchronization (like tapping or dancing) engages the endogenous opioid system (EOS), potentially leading to stronger analgesia and enhanced social bonding. The original study provided initial evidence supporting this, finding that actively tapping to music significantly reduced experimentally induced pain compared to passive music listening or silence conditions.
This replication study aims to confirm the primary finding that sensorimotor synchronization to music significantly reduces pain perception compared to passive music listening and control conditions. The study employs a 2x2 within-subjects factorial design with two factors: Auditory Condition (Music vs. Silence) and Task Condition (Active Tapping vs. Passive Control). Healthy adult participants will undergo all four conditions.
The primary methodological difference from the original study is the method of pain induction. Instead of pressure algometry, this study will use non-invasive transcutaneous electrical stimulation applied to the participant's forearm via a BIOPAC HSTM01 certified stimulus device. This change was implemented to allow for potentially greater precision and control over the stimulus intensity compared to manual pressure application. Pain intensity will be individually calibrated for each participant based on their pain threshold, ensuring only mild to moderate pain levels are experienced. Safety protocols, including screening for contraindications (e.g., pacemakers, epilepsy, pregnancy, local malignancies) and continuous monitoring, are in place.
Consistent with the original study, perceived pain intensity will be the primary outcome measure, rated on a numerical scale after each stimulus. Secondary measures, including ratings of emotional state (pleasantness, arousal), music familiarity, and music preference, will be collected to explore potential attentional and emotional mechanisms underlying the observed effects, as suggested by the original research. This replication seeks to provide robust evidence regarding the potential for active musical engagement, specifically sensorimotor synchronization, as a tool for pain management.
- Conditions
- Pain, Pain Management, Pain Threshold, Painful, Pain Intensity, Pain Intervention
- Being tested
- Music Listening, Silence Control, Active Sensorimotor Synchronization, Passive Control Task
- Keywords
- Pain, Pain Perception, Experimental Pain, Analgesia, Music, Music Listening, Sensorimotor Synchronization, Tapping, Rhythm, Electrical Pain Stimulation, Replication Study, Endogenous Opioid System, Attention, Emotion, Affect, Pain Management, Music Therapy
- Medical subject headings
- Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music ListeningOther
Participants listen to selected instrumental music excerpts presented via headphones during designated experimental trials.
Silence ControlOther
Participants experience periods of silence with no music presented via headphones during designated control trials. This serves as the auditory control condition compared to Music Listening.
Active Sensorimotor SynchronizationOther
Participants actively synchronize movements (such as foot tapping and/or head nodding) by timing them with the rhythm of the presented music or with a pacing stimulus provided during silent trials.
Passive Control TaskOther
Participants remain still and do not perform specific instructed synchronized movements during designated control trials. This serves as the motor task control condition compared to Active Sensorimotor Synchronization.
| Study group | Role | What they receive |
|---|---|---|
| Within-Subjects Conditions | Experimental | All participants experience all conditions in a 2x2 within-subjects factorial design. Interventions manipulate two factors: 1. Auditory Condition: Participants listen to selected music (via headphones) or experience silence. 2. Task Condition: Participants perform Active Sensorimotor Synchronization (syncing foot taps/head nods to music or pacing stimulus) or maintain Passive Control (remaining still). Each participant completes trials for all 4 resulting conditions: Music+Active, Music+Passive, Silence+Active, Silence+Passive. Condition order is counterbalanced across participants. During trials, brief non-invasive electrical pain stimuli (BIOPAC system) are delivered to the forearm; intensity is individually calibrated based on pain threshold. Key outcomes (perceived pain, emotional state ratings) are collected. Receives: Other: Music Listening; Other: Silence Control; Other: Active Sensorimotor Synchronization; Other: Passive Control Task |
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: Time Frame: 40 minutes (duration of time over which each participant is assessed)
Secondary outcomes (2)
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: Time Frame: 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: Time Frame: 40 minutes (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 posted7 May 2025
- Study start1 Mar 2025
- Primary completion20 Apr 2025
- Study completion20 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- All participants experience all conditions within a 2x2 within-subjects factorial design. Factors crossed are: 1. Auditory Condition (Music versus Silence) and 2. Task Condition (Active Sensorimotor Synchronization versus Passive Control). The Active task involves participants synchronizing movements (e.g., foot tapping, head nodding) to music or a pacing stimulus. The Passive task requires participants to remain still without performing these specific movements. This results in four experimental conditions: Music+Active, Music+Passive (Listening only), Silence+Active, and Silence+Passive. The order of these conditions is counterbalanced across participants. Brief, non-invasive electrical pain stimuli are delivered to the forearm during experimental trials.
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Collaborators
- The Research Council of Norway, European Research Council
- Responsible party
- Sponsor
- Investigators
- Stefan Koelsch, PhD, Principal investigator, Institute for Biological and Medical Psychology, University of Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06960226
- Sponsor's protocol ID
- REK NR 2019/1031 7236
- Acronym
- PainMusic2
- Status last verified
- Apr 2025
- First submitted
- 28 Apr 2025
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. 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
- NCT06960226
- Acronym / sponsor ID
- PainMusic2 / REK NR 2019/1031 7236
- Conditions
- Pain, Pain Management, Pain Threshold, Painful, Pain Intensity, Pain Intervention
- Keywords
- Pain, Pain Perception, Experimental Pain, Analgesia, Music, Music Listening, Sensorimotor Synchronization, Tapping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Collaborators
- The Research Council of Norway, European Research Council
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 20 Apr 2025 (actual)
- Study completion
- 20 Apr 2025 (actual)
- First posted
- 7 May 2025 (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.
The goal of this clinical trial is to confirm previous findings that actively tapping along to music can reduce pain more than just listening to music. This study aims to replicate the findings of a previous study (NCT05267795), with one change in how mild pain is created for the experiment. This study involves healthy adults.
The main questions the study aims to answer are:
- Does actively tapping along to music lower feelings of pain compared to just listening to music?
- Does actively tapping along to music lower feelings of pain compared to being in silence (with or without tapping)?
- Is this method of using music and tapping helpful for managing pain?
Researchers will compare the amount of pain participants feel in four different situations:
- Listening to music while actively tapping their foot along with it.
- Just listening to music while resting their foot.
- Actively tapping their foot in silence.
- Sitting in silence while resting their foot.
Participants in this study will:
Experience brief moments of mild pain on their forearm. This pain is safely created using a small electrical pulse from a device held gently on the skin by the researcher. (This replaces the pressure method used in the original study).
Sometimes listen to music through headphones, and sometimes sit in silence. Sometimes tap their foot along to the music or a beat, and sometimes rest their foot. Rate how much pain they feel on a number scale after each pain pulse. Answer short questions about their mood during the experiment. Answer questions about how familiar they are with the music and how much they liked it at the end.
Detailed description
This study is a pre-registered replication of a previous trial (NCT05267795) investigating the analgesic effects of sensorimotor synchronization to music. While music listening alone has shown small, albeit reliable, pain-reducing effects, recent theories propose that active synchronization (like tapping or dancing) engages the endogenous opioid system (EOS), potentially leading to stronger analgesia and enhanced social bonding. The original study provided initial evidence supporting this, finding that actively tapping to music significantly reduced experimentally induced pain compared to passive music listening or silence conditions.
This replication study aims to confirm the primary finding that sensorimotor synchronization to music significantly reduces pain perception compared to passive music listening and control conditions. The study employs a 2x2 within-subjects factorial design with two factors: Auditory Condition (Music vs. Silence) and Task Condition (Active Tapping vs. Passive Control). Healthy adult participants will undergo all four conditions.
The primary methodological difference from the original study is the method of pain induction. Instead of pressure algometry, this study will use non-invasive transcutaneous electrical stimulation applied to the participant's forearm via a BIOPAC HSTM01 certified stimulus device. This change was implemented to allow for potentially greater precision and control over the stimulus intensity compared to manual pressure application. Pain intensity will be individually calibrated for each participant based on their pain threshold, ensuring only mild to moderate pain levels are experienced. Safety protocols, including screening for contraindications (e.g., pacemakers, epilepsy, pregnancy, local malignancies) and continuous monitoring, are in place.
Consistent with the original study, perceived pain intensity will be the primary outcome measure, rated on a numerical scale after each stimulus. Secondary measures, including ratings of emotional state (pleasantness, arousal), music familiarity, and music preference, will be collected to explore potential attentional and emotional mechanisms underlying the observed effects, as suggested by the original research. This replication seeks to provide robust evidence regarding the potential for active musical engagement, specifically sensorimotor synchronization, as a tool for pain management.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants experience all conditions within a 2x2 within-subjects factorial design. Factors crossed are: 1. Auditory Condition (Music versus Silence) and 2. Task Condition (Active Sensorimotor Synchronization versus Passive Control). The Active task involves participants synchronizing movements (e.g., foot tapping, head nodding) to music or a pacing stimulus. The Passive task requires participants to remain still without performing these specific movements. This results in four experimental conditions: Music+Active, Music+Passive (Listening only), Silence+Active, and Silence+Passive. The order of these conditions is counterbalanced across participants. Brief, non-invasive electrical pain stimuli are delivered to the forearm during experimental trials.
| Arm | Type | Receives |
|---|---|---|
| Within-Subjects Conditions | Experimental | Other: Music Listening, Other: Silence Control, Other: Active Sensorimotor Synchronization, Other: Passive Control TaskAll participants experience all conditions in a 2x2 within-subjects factorial design. Interventions manipulate two factors: 1. Auditory Condition: Participants listen to selected music (via headphones) or experience silence. 2. Task Condition: Participants perform Active Sensorimotor Synchronization (syncing foot taps/head nods to music or pacing stimulus) or maintain Passive Control (remaining still). Each participant completes trials for all 4 resulting conditions: Music+Active, Music+Passive, Silence+Active, Silence+Passive. Condition order is counterbalanced across participants. During trials, brief non-invasive electrical pain stimuli (BIOPAC system) are delivered to the forearm; intensity is individually calibrated based on pain threshold. Key outcomes (perceived pain, emotional state ratings) are collected. |
Who may qualify
- Ages
- 19 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 18 years or older
- Self-reported good general health
- Able to understand study procedures and provide informed consent
- Normal or corrected-to-normal hearing (sufficient for music perception)
Key exclusion criteria (16 listed)
- Contraindications for Electrical Stimulation:
- Medical/Neurological History:
- Medication Use:
- Study-Specific:
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 |
|---|---|---|
| Music ListeningParticipants listen to selected instrumental music excerpts presented via headphones during designated experimental trials. | Other | Within-Subjects Conditions |
| Silence ControlParticipants experience periods of silence with no music presented via headphones during designated control trials. This serves as the auditory control condition compared to Music Listening. | Other | Within-Subjects Conditions |
| Active Sensorimotor SynchronizationParticipants actively synchronize movements (such as foot tapping and/or head nodding) by timing them with the rhythm of the presented music or with a pacing stimulus provided during silent trials. | Other | Within-Subjects Conditions |
| Passive Control TaskParticipants remain still and do not perform specific instructed synchronized movements during designated control trials. This serves as the motor task control condition compared to Active Sensorimotor Synchronization. | Other | Within-Subjects Conditions |
Primary outcome
Perceived Pain
Time frame: 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)
2 secondary outcomes
Emotional state with regard to felt pleasantness
Time frame: Time Frame: 40 minutes (duration of time over which each participant is assessed)
Emotional state with regard to felt arousal
Time frame: Time Frame: 40 minutes (duration of time over which each participant is assessed)
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 7 May 2025.
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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
Institute for Biological and Medical Psychology, University of Bergen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music Listening and Active Sensorimotor Synchronization in people with Pain and Pain Management, 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 4 inclusion and 16 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 7 May 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 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: Time Frame: 40 minutes (duration of time over which each participant is assessed)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 May 2025.