- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05267795
Reducing Pain With Focused Music Listening (PainMusic)
March 3, 2022 updated by: University of Bergen
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
62
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bergen Municipality
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Bergen, Bergen Municipality, Norway, 5020
- University of Bergen
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18 years or older
- Healthy
Exclusion Criteria:
- History of a psychiatric or neurological disease
- History of substance dependence
- use of any prescription drugs
- Hearing impairment
- Musical anhedonia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Operationalization
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.
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Specific pain levels were applied on the participants' fingernails in each of 40 experimental trials using pressure algometry.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Perceived Pain
Time Frame: 40 minutes (duration of time over which each participant is assessed)
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rated on a scale ranging from 1 to 9 (1 = very little, 5 = medium, 9 = very strong)
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40 minutes (duration of time over which each participant is assessed)
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Emotional state with regard to felt pleasantness
Time Frame: 40 minutes (duration of time over which each participant is assessed)
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rated on a scale ranging from 1 to 9 (1 = very uncomfortable, 5 = medium, 9 = very comfortable)
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40 minutes (duration of time over which each participant is assessed)
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Emotional state with regard to felt arousal
Time Frame: 40 minutes (duration of time over which each participant is assessed)
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rated on a scale ranging from 1 to 9 (1 = very calm, 5 = medium, 9 = very activated)
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40 minutes (duration of time over which each participant is assessed)
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Familiarity with the music excerpt (only during trials with music)
Time Frame: 40 minutes (duration of time over which each participant is assessed)
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rated on a scale ranging from 1 to 9 (1 = not at all, 5 = partially known, 9 = well known)
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40 minutes (duration of time over which each participant is assessed)
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Preference ratings for each musical excerpt
Time Frame: 5 min (duration of time over which each participant is assessed)
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rated on a scale ranging from 1 to 9 (1 = strongly disliked, 5 = medium, 9 = strongly liked)
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5 min (duration of time over which each participant is assessed)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Stefan Koelsch, PhD, University of Bergen, Norway
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 22, 2019
Primary Completion (Actual)
October 30, 2020
Study Completion (Actual)
October 30, 2020
Study Registration Dates
First Submitted
January 31, 2022
First Submitted That Met QC Criteria
March 3, 2022
First Posted (Actual)
March 4, 2022
Study Record Updates
Last Update Posted (Actual)
March 4, 2022
Last Update Submitted That Met QC Criteria
March 3, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- BFS Toppforsk
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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