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| Name | Class |
|---|---|
| Sorbonne University | OTHER |
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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:
Participants will:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Contextualized Music | Experimental | 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phase 1 - Silence (Baseline) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Tolerance Duration | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Reaction Time to Pain | 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. | 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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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Antonine University | Baabda | Lebanon |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15820909 | Background | von Baeyer CL, Piira T, Chambers CT, Trapanotto M, Zeltzer LK. Guidelines for the cold pressor task as an experimental pain stimulus for use with children. J Pain. 2005 Apr;6(4):218-27. doi: 10.1016/j.jpain.2005.01.349. | |
| 24468081 | Background | La Cesa S, Tinelli E, Toschi N, Di Stefano G, Collorone S, Aceti A, Francia A, Cruccu G, Truini A, Caramia F. fMRI pain activation in the periaqueductal gray in healthy volunteers during the cold pressor test. Magn Reson Imaging. 2014 Apr;32(3):236-40. doi: 10.1016/j.mri.2013.12.003. Epub 2013 Dec 19. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 19, 2026 | |
| Reset | May 8, 2026 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 14, 2025 |
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| Phase 2 - Happy Mode with Measured Rhythm | Behavioral | Participants undergo the cold pressor test while listening to music characterized by a happy emotional mode and a regular, measured rhythmic structure. |
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| Phase 3 - Sad Mode with Measured Rhythm | Behavioral | Participants undergo the cold pressor test while listening to music characterized by a sad emotional mode and a regular, measured rhythmic structure. |
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| Phase 4 - Happy Mode with Non-Measured Rhythm | Behavioral | Participants undergo the cold pressor test while listening to music characterized by a happy emotional mode and a non-measured (free) rhythmic structure. |
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| Phase 5 - Sad Mode with Non-Measured Rhythm Type: Behavioral | Behavioral | 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. |
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| Phase 6 - Participant-Selected from Predefined Set | Behavioral | 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. |
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| Phase 7 - Silence (Post-Exposure) | Behavioral | 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. |
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| Phase 8 - Participant's Own Choice | Behavioral | Optional intervention : participants undergo the cold pressor test while listening to a self-selected piece of music of their own choosing. |
|
| Pain Intensity | 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." | 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. |
| Qualitative Feedback | A study-specific, 15-item multi-dimensional questionnaire designed to evaluate participants' subjective experience across:
| 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. |
| 32223612 | Background | Johnson AJ, Elkins GR. Effects of Music and Relaxation Suggestions on Experimental Pain. Int J Clin Exp Hypn. 2020 Apr-Jun;68(2):225-245. doi: 10.1080/00207144.2020.1719842. |
| 30080889 | Background | Choi S, Park SG, Lee HH. The analgesic effect of music on cold pressor pain responses: The influence of anxiety and attitude toward pain. PLoS One. 2018 Aug 6;13(8):e0201897. doi: 10.1371/journal.pone.0201897. eCollection 2018. |
| 15878297 | Background | 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. |
| Mar 31, 2026 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 14, 2025 | Mar 31, 2026 | ICF_001.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 19, 2026 | May 8, 2026 |
| ID | Term |
|---|---|
| D000377 | Agnosia |
| D010146 | Pain |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C074807 | BaseLine dental cement |
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