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Completed

NCT Number: NCT07515196

The Sedative Effects of Music Listening on Pain During 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.

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Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Antonine University

Baabda, Lebanon

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

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.

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.

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.

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.

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.

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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."

  3. 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:

    • 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.

Sponsors and collaborators

Lead sponsor

Rawane El Dimachki

Other

Collaborators

  • Sorbonne University

Registry information

Official study title

Evaluation of the Sedative Effect of Music Listening on Pain Induced by a Thermal Stimulus (Cold Pressor Test)

Acronym: ESEMP

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 7, 2026
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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