- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07515196
The Sedative Effects of Music Listening on Pain During Cold Pressor Test (ESEMP)
Evaluation of the Sedative Effect of Music Listening on Pain Induced by a Thermal Stimulus (Cold Pressor Test)
This study aims to understand whether listening to music can reduce pain and anxiety caused by a cold-temperature stimulus in healthy young adults (n = 30). It also seeks to identify which musical and neurocognitive factors can produce a calming, analgesic (reduce pain), and anxiolytic (reduce anxiety) effect.
The main questions it aims to answer are:
- Does music based on universal musical features (such as melodic structure, modal scales, intervals, and tempo) help reduce pain and anxiety, regardless of culture or personal taste?
- Does music that reflects the participant's cultural rhythmic background-especially rhythmic styles from the Levant-change how pain and anxiety are perceived during the cold test?
- Does music selected according to each participant's personal listening habits and musical preferences have a sedative, analgesic, and anxiolytic effect?
- Are the calming effects of music the result of multiple combined factors-universal musical traits, cultural influences, and personal preferences-and how do these factors interact to create an overall therapeutic effect during the cold test?
Participants will:
- Take part in 1 session of 7 or 8 phases of cold pressor test
- Give their feedback in a qualitative questionnaire after each phase
- Answer brief questions about their musical background and preferences
This study aims to deepen our understanding of how musical and neurocognitive elements contribute to the sedative effect of music during care situations, and to support the development of a more precise and personalized musical model for use in dental procedures.
Study Overview
Status
Conditions
Intervention / Treatment
- Behavioral: Phase 1 - Silence (Baseline)
- Behavioral: Phase 2 - Happy Mode with Measured Rhythm
- Behavioral: Phase 3 - Sad Mode with Measured Rhythm
- Behavioral: Phase 4 - Happy Mode with Non-Measured Rhythm
- Behavioral: Phase 5 - Sad Mode with Non-Measured Rhythm Type: Behavioral
- Behavioral: Phase 6 - Participant-Selected from Predefined Set
- Behavioral: Phase 7 - Silence (Post-Exposure)
- Behavioral: Phase 8 - Participant's Own Choice
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Baabda, Lebanon
- Antonine University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Healthy volunteers aged 18 to 35 years.
- Ability to provide written informed consent.
- Willingness to comply with the study protocol and attend the session.
Exclusion Criteria:
- Participants with acute or chronic pain.
- Participants with a history of cardiovascular disorders.
- Participants currently taking analgesic medications.
- Participants with a recent wound on either hand.
- Participants with a history of hand fracture.
- Participants with dermatological conditions affecting the hand.
- Participants with a history of frostbite.
- Participants currently taking neuropsychiatric medications.
- Participants able to keep their hand immersed for 4 minutes during the silence (control) phase of the cold pressor test.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- 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: Contextualized Music
All participants undergo eight sequential experimental conditions (phases) of the cold pressor test under different controlled conditions (silence, happy music with measures rhythm, sad music with measured rhythm, happy music with non measured rhythm, sad music with non measured rhythm, their own music, music chosed from a palette).
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Participants undergo the cold pressor test in complete silence without any auditory stimulation.
This baseline condition serves as a control for comparison with subsequent music conditions.
Participants undergo the cold pressor test while listening to music characterized by a happy emotional mode and a regular, measured rhythmic structure.
Participants undergo the cold pressor test while listening to music characterized by a sad emotional mode and a regular, measured rhythmic structure.
Participants undergo the cold pressor test while listening to music characterized by a happy emotional mode and a non-measured (free) rhythmic structure.
Participants undergo the cold pressor test while listening to music characterized by a sad emotional mode and a non-measured (free or irregular) rhythmic structure.
Participants undergo the cold pressor test while listening to a piece of music selected by themselves from a predefined set of musical options provided by the researchers.
Participants undergo the cold pressor test in silence following prior experimental conditions.
This control condition is included to assess potential changes in pain tolerance over time and to distinguish music effects from habituation or adaptation.
Optional intervention : participants undergo the cold pressor test while listening to a self-selected piece of music of their own choosing.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pain Tolerance Duration
Time Frame: Within a single study session (approximately 90 minutes); measured (from hand immersion to withdrawal) during 8 distinct cold pressor test phases, with each phase lasting up to a maximum of 4 minutes.
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Pain tolerance will be measured as the total duration (in seconds) that participants are able to keep their hand immersed in cold water during each phase.
A stopwatch will be used to record immersion time.
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Within a single study session (approximately 90 minutes); measured (from hand immersion to withdrawal) during 8 distinct cold pressor test phases, with each phase lasting up to a maximum of 4 minutes.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reaction Time to Pain
Time Frame: Within a single study session (approximately 90 minutes); measured from initial hand immersion to the onset of pain perception during each of the 8 distinct cold pressor test phases (each phase lasting a maximum of 4 minutes).
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The time elapsed between the onset of hand immersion in cold water and the participant's first reported perception of pain will be recorded.
This measure provides insight into how musical conditions may influence the temporal perception of pain onset.
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Within a single study session (approximately 90 minutes); measured from initial hand immersion to the onset of pain perception during each of the 8 distinct cold pressor test phases (each phase lasting a maximum of 4 minutes).
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Pain Intensity
Time Frame: Within a single study session (approximately 90 minutes); assessed continuously during 8 distinct cold pressor test phases, with each phase lasting up to 4 minutes.
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Pain intensity is assessed using a Visual Analog Scale (VAS), where participants rate their perceived pain during each phase of the cold pressor test.
The scale ranges from 0 to 10, where 0 represents "no pain" and 10 represents "the worst possible pain."
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Within a single study session (approximately 90 minutes); assessed continuously during 8 distinct cold pressor test phases, with each phase lasting up to 4 minutes.
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Qualitative Feedback
Time Frame: Within a single study session (approximately 90 minutes); assessed after each of the 8 cold pressor test phases (each phase lasting a maximum of 4 minutes) and at the conclusion of the session.
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A study-specific, 15-item multi-dimensional questionnaire designed to evaluate participants' subjective experience across:
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Within a single study session (approximately 90 minutes); assessed after each of the 8 cold pressor test phases (each phase lasting a maximum of 4 minutes) and at the conclusion of the session.
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- von Baeyer C, Piira T, Chambers C, Trapanotto M & Zelter L (2005). Guidelines for the cold pressor task as an experimental pain stimulus for use with children The Journal of Pain, 6, 218-227
- La Cesa S, Tinelli E, Toschi N, Di Stefano G, Collorone S, Aceti A, Francia A, Cruccu G, Truini A, and Caramia F. fMRI pain activation in the periaqueductal gray in healthy volunteers during the cold pressor test. Magnetic resonance imaging. 2014; vol. 32, no. 3: 236-240. https://doi.org/10.1016/j.mri.2013.12.003
- Alisa J. Johnson & Gary R. Elkins (2020) Effects of Music and Relaxation Suggestions on Experimental Pain, International Journal of Clinical and Experimental Hypnosis, 68:2, 225-245, DOI: 10.1080/00207144.2020.1719842
- Choi S,Park SG,Lee HH
- Mitchell LA, MacDonald RA, Brodie EE. A comparison of the effects of preferred music, arithmetic and humour on cold pressor pain. Eur J Pain. 2006 May;10(4):343-51. doi: 10.1016/j.ejpain.2005.03.005.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2431-2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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