NCT06960226

Brief 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. This study involves healthy adults. The main questions the study aims to answer are:

  1. 1.Does actively tapping along to music lower feelings of pain compared to just listening to music?
  2. 2.Does actively tapping along to music lower feelings of pain compared to being in silence (with or without tapping)?
  3. 3.Is this method of using music and tapping helpful for managing pain?
  4. 4.Listening to music while actively tapping their foot along with it.
  5. 5.Just listening to music while resting their foot.
  6. 6.Actively tapping their foot in silence.
  7. 7.Sitting in silence while resting their foot.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2025

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

April 28, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 7, 2025

Completed
Last Updated

May 7, 2025

Status Verified

April 1, 2025

Enrollment Period

2 months

First QC Date

April 28, 2025

Last Update Submit

April 28, 2025

Conditions

Keywords

PainPain PerceptionExperimental PainAnalgesiaMusicMusic ListeningSensorimotor SynchronizationTappingRhythmElectrical Pain StimulationReplication StudyEndogenous Opioid SystemAttentionEmotionAffectPain ManagementMusic Therapy

Outcome Measures

Primary Outcomes (1)

  • Perceived Pain

    rated on a scale ranging from 1 to 9 (1 = very little, 5 = medium, 9 = very strong)

    Time Frame: 40 minutes (duration of time over which each participant is assessed)

Secondary Outcomes (2)

  • Emotional state with regard to felt pleasantness

    Time Frame: 40 minutes (duration of time over which each participant is assessed)

  • Emotional state with regard to felt arousal

    Time Frame: 40 minutes (duration of time over which each participant is assessed)

Other Outcomes (2)

  • Familiarity with the music excerpt (only during trials with music)

    Time Frame: 40 minutes (duration of time over which each participant is assessed)]

  • Liking ratings for each musical excerpt

    Time Frame: 5 min (duration of time over which each participant is assessed)

Study Arms (1)

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.

Other: Music ListeningOther: Silence ControlOther: Active Sensorimotor SynchronizationOther: Passive Control Task

Interventions

Participants listen to selected instrumental music excerpts presented via headphones during designated experimental trials.

Within-Subjects Conditions

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.

Within-Subjects Conditions

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.

Within-Subjects Conditions

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.

Within-Subjects Conditions

Eligibility Criteria

Age19 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)
  • 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)
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Bergen

Bergen, 5003, Norway

Location

MeSH Terms

Conditions

PainAgnosia

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Study Officials

  • Stefan Koelsch, PhD

    Institute for Biological and Medical Psychology, University of Bergen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2025

First Posted

May 7, 2025

Study Start

March 1, 2025

Primary Completion

April 20, 2025

Study Completion

April 20, 2025

Last Updated

May 7, 2025

Record last verified: 2025-04

Locations