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CompletedNCT07515196ESEMPUpdated Apr 7, 2026

The Sedative Effects of Music Listening on Pain During Cold Pressor Test

An interventional study of Phase 1 - Silence (Baseline) and Phase 2 - Happy Mode with Measured Rhythm in Analgesic Effects of Music, sponsored by Rawane El Dimachki. Completed at 1 site in Lebanon. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-07.

Sponsored by Rawane El Dimachki · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Nov 2025, registered Mar 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years to 35 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Analgesic Effects of Music

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Keywords

  • Music-induced sedation
  • Analgesia
  • Anxiety reduction
  • Music therapy
  • Cultural music context
  • Pain
  • Musical structure
  • Cold pressor test
03

In context

Agnosia

1,190 studies on the registry are indexed under Agnosia; 508 are open to participants now.

This study's enrollment of 40 is below the median of 78 across 1,024 interventional studies indexed under Agnosia.

Browse Agnosia studies →

Lead sponsor

Rawane El Dimachki is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • 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).

    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

Interventions

  • BehavioralPhase 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.

  • BehavioralPhase 2 - Happy Mode with Measured Rhythm

    Participants undergo the cold pressor test while listening to music characterized by a happy emotional mode and a regular, measured rhythmic structure.

  • BehavioralPhase 3 - Sad Mode with Measured Rhythm

    Participants undergo the cold pressor test while listening to music characterized by a sad emotional mode and a regular, measured rhythmic structure.

  • BehavioralPhase 4 - Happy Mode with Non-Measured Rhythm

    Participants undergo the cold pressor test while listening to music characterized by a happy emotional mode and a non-measured (free) rhythmic structure.

  • BehavioralPhase 5 - Sad Mode with Non-Measured Rhythm Type: 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.

  • BehavioralPhase 6 - Participant-Selected from Predefined Set

    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.

  • BehavioralPhase 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.

  • BehavioralPhase 8 - Participant's Own Choice

    Optional intervention : participants undergo the cold pressor test while listening to a self-selected piece of music of their own choosing.

06

What researchers measure

Primary outcomes

  1. 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.

    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.

Secondary outcomes

  1. 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.

    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).

  2. 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."

    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.

  3. Qualitative Feedback

    A study-specific, 15-item multi-dimensional questionnaire designed to evaluate participants' subjective experience across: 1. Pain and Anxiety Perception (e.g., categorical rating from "Mild" to "Intense"). 2. Emotional Response to Music (e.g., 5-point scale from "Very Relaxed" to "Anxious"). 3. Music Preference and Familiarity (e.g., selection of preferred musical mode). 4. 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.

    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.

07

Study locations

1 site
  • Antonine University
    Baabda, Lebanon
08

References and documents

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 15820909 ↗
  • 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. PubMed 24468081 ↗
  • 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. PubMed 32223612 ↗
  • 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. PubMed 30080889 ↗
  • 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. PubMed 15878297 ↗

Study documents

  • Protocol and statistical analysis plan · Nov 14, 2025
  • Informed consent form · Nov 14, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07515196
Lead sponsor
Rawane El Dimachki
Collaborators
Sorbonne University
Responsible party
Rawane El Dimachki (Chairperson of the Music Therapy department, Antonine University) — Sponsor-investigator
First posted
Apr 7, 2026
Start date
Nov 14, 2025
Primary completion
Jan 15, 2026
Completion
Jan 15, 2026
Last update
Apr 7, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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