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Completed

NCT Number: NCT03914105

Central Neuromodulation of Pain Through Music in Healthy Subjects

The present research aims to study the neuromodulatory effect of music on the sensory component of pain. The activation of pain control systems, through music, would pave the way for rehabilitation prospects for patients with a deficit of these controls.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHRU Brest

Brest, 29200, France

About this study

Pain is a multidimensional, complex and universal phenomenon that would be faced by almost one in two European adults. To meet the needs in terms of public health, contemporary medicine is gradually reintegrating the use of complementary therapeutic methods. Music therapy is a non-medical intervention that is particularly suited to pain problems. The therapeutic use of music is an economical, practical and safe method. Many clinical studies show that this activity promotes a significant decrease in pain. The ability of passive listening to music to reduce the perception of pain has been called "music-induced analgesia". The neuro-psycho-physiological mechanisms that underlie this phenomenon remain poorly understood. One hypothesis, still discussed, proposes that listening to music would stimulate, directly or indirectly, endogenous mechanisms of modulation of pain, stemming from the brainstem. In individuals undergoing nociceptive tonic stimulation, the specific neuronal activation induced by listening to music demonstrates the involvement of inhibitory descending pathways. A measurement of pain control mechanisms would account for the impact of music on central awareness.

The purpose of this research is therefore to study the neuromodulatory effect of music on the sensory component of pain. The activation of pain control systems, through music, would pave the way for rehabilitation prospects for patients with a deficit of these controls.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy subjects aged 18 to 65
  • Subjects informed of the constraints of the study and having given their written consent.
  • Subjects benefiting from a social security scheme.

Exclusion criteria

  • Subjects under 18 and over 65
  • Subjects who have previously participated in a pain study involving the induced pain test.
  • Subjects with serious psychiatric disorders.
  • Subjects with a diagnosis of acute or chronic pain.
  • Subjects who have been taking antalgic substances for less than a week.
  • Subjects with progressive disease not stabilized by medical treatment.
  • Women in menstruation.
  • Pregnant women.
  • Subjects with a score greater than 10 for the Depressive Dimension on Hospital Anxiety and Depression Scale (HADS)
  • Subjects with an anxiety score "state" higher than anxiety "traits" on the Spielberger condition state / traits anxiety inventory (STAI)
  • Subjects with a score of 32 or higher on the Catastrophe Rating Scale (PCS-CF)
  • Non-cooperating person.
  • Person under legal protection
  • Subjects not benefiting from a social security scheme
  • Refusal of participation

Treatment and study plan

Without music

Procedure

The starting condition will be "without music": the subjects, after a rest period of 10 minutes, will perform a test of induced pain for 6 minutes. There will be no music for the duration.

With music

Procedure

The starting condition will be "with music": the subjects, after a rest period of 10 minutes, will perform a test of induced pain for 6 minutes. There will be music for the duration.

Primary outcomes

  1. Evaluation of Visual Analogue scale (VAS)

    Time frame: 20 minutes

    Visual Analogue Scale (VAS) measured at 2 minutes of stimulation during the temporal summation phase, starting from a basic VAS calibrated at 50/100.

    Pain is assessed continuously throughout this test using a computerized analog visual scale.

Secondary outcomes

  1. Average VAS of the subject over the period P1

    Time frame: 2 minutes

    The period P1 represents the first stimulation or the first time summation test. It is a tonic pain test by applying the thermode. The average VAS will be measured during this period.

    Pain is assessed continuously throughout this test using a computerized analog visual scale.

  2. Average VAS of the subject over the period P2

    Time frame: 2 minutes

    The period P2 represents the second stimulation or activation of the DNIC (Diffuse Nociceptive Inhibitive Control). This is the induction of cold thermal nociceptive stimulation (CPT : cold pressor test). The average VAS will be measured during this period.

    Pain is assessed continuously throughout this test using a computerized analog visual scale.

  3. Average VAS of the subject over the period P3

    Time frame: 2 minutes

    The period P3 represents the third stimulation or the second time summation test. This is the second tonic pain test by applying the thermode.The average VAS will be measured during this period.

    Pain is assessed continuously throughout this test using a computerized analog visual scale.

  4. Evaluation of numerical scale

    Time frame: 20 minutes

    Numerical scale (overall numerical scale over the period) will be measured for each stimulation period (P1, P2, P3).

    This scale assesses pain and is graded from 0 (no pain) to 100 (maximum pain imaginable).

  5. Difference in average VAS P1-P3

    Time frame: 20 minutes

    The difference in average VAS between period P1 and period P3 will be calculated.

    Pain is assessed continuously throughout this test using a computerized analog visual scale.

  6. Difference in Pressure Pain Threshold (PPT) before and after the procedure

    Time frame: 1 hour and 30 minutes

    The difference in Pressure Pain Threshold (PPT) will be measured before and after the procedure.

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study title

Central Neuromodulation of Pain Through Music in Healthy Subjects (DOUMU1)

Acronym: DOUMU1

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 16, 2019
Registry last updated
Dec 14, 2021

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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