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

March 31, 2026 updated by: Rawane El Dimachki

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

Study Type

Interventional

Enrollment (Actual)

40

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

      • Baabda, Lebanon
        • Antonine University

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

  • Adult

Accepts Healthy Volunteers

Yes

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

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: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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).
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 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).
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).
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.
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
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.

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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

November 14, 2025

Primary Completion (Actual)

January 15, 2026

Study Completion (Actual)

January 15, 2026

Study Registration Dates

First Submitted

March 25, 2026

First Submitted That Met QC Criteria

March 31, 2026

First Posted (Actual)

April 7, 2026

Study Record Updates

Last Update Posted (Actual)

April 7, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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