Central Neuromodulation of Pain Through Music in Healthy Subjects

NCT ID: NCT03914105

Last Updated: 2021-12-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-15
• Study Completion Date: 2020-02-25

Brief Summary

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.

Detailed Description

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.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Without music

Test without music

Group Type: ACTIVE_COMPARATOR

Without music

Intervention Type: 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

Group Type: EXPERIMENTAL

With music

Intervention Type: 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.

Interventions

Without music

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.

Intervention Type: PROCEDURE

With music

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Brest

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gildas L'Heveder, MD

Role: STUDY_DIRECTOR

Brest University Hospital in France

Céline Bodere, MD

Role: PRINCIPAL_INVESTIGATOR

Brest University Hospital in France

Locations

CHRU Brest

Brest, , France

Countries

France

Other Identifiers

DOUMU1 (29BRC19.0039)

Identifier Type: -

Identifier Source: org_study_id