Analgesic Effects of MusicESEMPNCT07515196
The Sedative Effects of Music Listening on Pain During Cold Pressor Test
A study testing Phase 1 - Silence (Baseline), Phase 2 - Happy Mode with Measured Rhythm and Phase 3 - Sad Mode with Measured Rhythm in people with Analgesic Effects of Music, run by Rawane El Dimachki at 1 site in Lebanon.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Analgesic Effects of Music
- What is being tested?
- Phase 1 - Silence (Baseline), Phase 2 - Happy Mode with Measured Rhythm and Phase 3 - Sad Mode with Measured Rhythm
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteLebanon
- Study dates
- 14 Nov 2025to 15 Jan 2026
- 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers aged 18 to 35 years.
- Ability to provide written informed consent.
- Willingness to comply with the study protocol and attend the session.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
Read more
- 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.
- Conditions
- Analgesic Effects of Music
- Being tested
- Phase 1 - Silence (Baseline), Phase 2 - Happy Mode with Measured Rhythm, Phase 3 - Sad Mode with Measured Rhythm, Phase 4 - Happy Mode with Non-Measured Rhythm, Phase 5 - Sad Mode with Non-Measured Rhythm Type: Behavioral
- Keywords
- Music-induced sedation, Analgesia, Anxiety reduction, Music therapy, Cultural music context, Pain, Musical structure, Cold pressor test
- Medical subject headings
- Agnosia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phase 1 - Silence (Baseline)Behavioural
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.
Phase 2 - Happy Mode with Measured RhythmBehavioural
Participants undergo the cold pressor test while listening to music characterized by a happy emotional mode and a regular, measured rhythmic structure.
Phase 3 - Sad Mode with Measured RhythmBehavioural
Participants undergo the cold pressor test while listening to music characterized by a sad emotional mode and a regular, measured rhythmic structure.
Phase 4 - Happy Mode with Non-Measured RhythmBehavioural
Participants undergo the cold pressor test while listening to music characterized by a happy emotional mode and a non-measured (free) rhythmic structure.
Phase 5 - Sad Mode with Non-Measured Rhythm Type: BehavioralBehavioural
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.
Phase 6 - Participant-Selected from Predefined SetBehavioural
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.
Phase 7 - Silence (Post-Exposure)Behavioural
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.
Phase 8 - Participant's Own ChoiceBehavioural
Optional intervention : participants undergo the cold pressor test while listening to a self-selected piece of music of their own choosing.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Secondary outcomes (3)
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.
Measured: 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).
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."
Measured: 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:
- Pain and Anxiety Perception (e.g., categorical rating from "Mild" to "Intense").
- Emotional Response to Music (e.g., 5-point scale from "Very Relaxed" to "Anxious").
- Music Preference and Familiarity (e.g., selection of preferred musical mode).
- Cumulative Experience (e.g., comparative assessment of pain tolerance). For the scaled items (such as Question 7: "Effect of music on pain level"), scores range from 1 (No effect) to 5 (Very significant effect), where higher scores indicate a better outcome (greater perceived music effectiveness). Qualitative open-ended responses regarding emotional tone and rhythm are collected to provide contextual depth to the physiological data.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start14 Nov 2025
- Primary completion15 Jan 2026
- Study completion15 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Analgesic Effects of MusicStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rawane El Dimachki
- Sponsor type
- University, hospital or other
- Collaborators
- Sorbonne University
- Responsible party
- Sponsor-investigator, Rawane El Dimachki, Antonine University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07515196
- Sponsor's protocol ID
- 2431-2025
- Acronym
- ESEMP
- Status last verified
- Mar 2026
- First submitted
- 25 Mar 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 15820909La 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.
PubMed 24468081Johnson 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.
PubMed 32223612Choi 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.
PubMed 30080889Mitchell 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.
PubMed 15878297
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Sedative Effect of Music Listening on Pain Induced by a Thermal Stimulus (Cold Pressor Test)
- ClinicalTrials.gov ID
- NCT07515196
- Acronym / sponsor ID
- ESEMP / 2431-2025
- Conditions
- Analgesic Effects of Music
- Keywords
- Music-induced sedation, Analgesia, Anxiety reduction, Music therapy, Cultural music context, Pain, Musical structure, Cold pressor test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Rawane El DimachkiUniversity, hospital or other
- Collaborators
- Sorbonne University
- Study start
- 14 Nov 2025 (actual)
- Primary completion
- 15 Jan 2026 (actual)
- Study completion
- 15 Jan 2026 (actual)
- First posted
- 7 Apr 2026 (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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Contextualized Music | Experimental | 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 ChoiceAll 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). |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy volunteers aged 18 to 35 years.
- Ability to provide written informed consent.
- Willingness to comply with the study protocol and attend the session.
Key exclusion criteria (9 listed)
- 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.
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 |
|---|---|---|
| Phase 1 - Silence (Baseline)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. | Behavioural | Contextualized Music |
| Phase 2 - Happy Mode with Measured RhythmParticipants undergo the cold pressor test while listening to music characterized by a happy emotional mode and a regular, measured rhythmic structure. | Behavioural | Contextualized Music |
| Phase 3 - Sad Mode with Measured RhythmParticipants undergo the cold pressor test while listening to music characterized by a sad emotional mode and a regular, measured rhythmic structure. | Behavioural | Contextualized Music |
| Phase 4 - Happy Mode with Non-Measured RhythmParticipants undergo the cold pressor test while listening to music characterized by a happy emotional mode and a non-measured (free) rhythmic structure. | Behavioural | Contextualized Music |
| Phase 5 - Sad Mode with Non-Measured Rhythm Type: BehavioralParticipants undergo the cold pressor test while listening to music characterized by a sad emotional mode and a non-measured (free or irregular) rhythmic structure. | Behavioural | Contextualized Music |
| Phase 6 - Participant-Selected from Predefined SetParticipants 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. | Behavioural | Contextualized Music |
| Phase 7 - Silence (Post-Exposure)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. | Behavioural | Contextualized Music |
| Phase 8 - Participant's Own ChoiceOptional intervention : participants undergo the cold pressor test while listening to a self-selected piece of music of their own choosing. | Behavioural | Contextualized Music |
Primary outcome
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.
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.
3 secondary outcomes
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).
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.
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.
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 Apr 2026.
- Background: PubMed 15820909von 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.
- Background: PubMed 24468081La 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.
- Background: PubMed 32223612Johnson 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.
- Background: PubMed 30080889Choi 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.
- Background: PubMed 15878297Mitchell 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.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phase 1 - Silence (Baseline), Phase 2 - Happy Mode with Measured Rhythm and Phase 3 - Sad Mode with Measured Rhythm in people with Analgesic Effects of Music, run by Rawane El Dimachki at 1 site in Lebanon.
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 3 inclusion and 9 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 Apr 2026. 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 Lebanon. 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?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07515196, which also lists 5 linked publications.
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 Apr 2026.