NCT03914105

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable pain

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 11, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 16, 2019

Completed
6 months until next milestone

Study Start

First participant enrolled

October 15, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2020

Completed
Last Updated

December 14, 2021

Status Verified

December 1, 2021

Enrollment Period

4 months

First QC Date

April 11, 2019

Last Update Submit

December 12, 2021

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

  • Evaluation of Visual Analogue scale (VAS)

    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.

    20 minutes

Secondary Outcomes (6)

  • Average VAS of the subject over the period P1

    2 minutes

  • Average VAS of the subject over the period P2

    2 minutes

  • Average VAS of the subject over the period P3

    2 minutes

  • Evaluation of numerical scale

    20 minutes

  • Difference in average VAS P1-P3

    20 minutes

  • +1 more secondary outcomes

Study Arms (2)

Without music

ACTIVE COMPARATOR

Test without music

Procedure: Without music

With music

EXPERIMENTAL
Procedure: With music

Interventions

Without musicPROCEDURE

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.

Without music
With musicPROCEDURE

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.

With music

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU Brest

Brest, 29200, France

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Gildas L'Heveder, MD

    Brest University Hospital in France

    STUDY DIRECTOR

  • Céline Bodere, MD

    Brest University Hospital in France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2019

First Posted

April 16, 2019

Study Start

October 15, 2019

Primary Completion

February 25, 2020

Study Completion

February 25, 2020

Last Updated

December 14, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will share

All collected data that underlie results in a publication

Shared Documents
STUDY PROTOCOL
Time Frame
Data will be available after the publication of result and ending fifteen years following the last visit of the last patient
Access Criteria
Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

Locations

FR(1)