PainDOUMU1NCT03914105
Central Neuromodulation of Pain Through Music in Healthy Subjects
A study testing Without music and With music in people with Pain, run by University Hospital, Brest at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Without music and With music
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 15 Oct 2019to 25 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Central Neuromodulation of Pain Through Music in Healthy Subjects (DOUMU1)
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.
Read the 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
- Being tested
- Without music, With music
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Without musicProcedure or surgery
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 musicProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Without music | Active comparator | Test without music Receives: Procedure: Without music |
| With music | Experimental | Not described Receives: Procedure: With music |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 20 minutes
Secondary outcomes (6)
Average VAS of the subject over the period P1
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.
Measured: 2 minutes
Average VAS of the subject over the period P2
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.
Measured: 2 minutes
Average VAS of the subject over the period P3
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.
Measured: 2 minutes
Evaluation of numerical scale
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).
Measured: 20 minutes
Difference in average VAS P1-P3
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.
Measured: 20 minutes
Difference in Pressure Pain Threshold (PPT) before and after the procedure
The difference in Pressure Pain Threshold (PPT) will be measured before and after the procedure.
Measured: 1 hour and 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start15 Oct 2019
- Primary completion25 Feb 2020
- Study completion25 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gildas L'Heveder, MD, Study director, Brest University Hospital in FranceCéline Bodere, MD, Principal investigator, Brest University Hospital in France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03914105
- Sponsor's protocol ID
- DOUMU1 (29BRC19.0039)
- Acronym
- DOUMU1
- Status last verified
- Dec 2021
- First submitted
- 11 Apr 2019
- Last updated
- 14 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central Neuromodulation of Pain Through Music in Healthy Subjects (DOUMU1)
- ClinicalTrials.gov ID
- NCT03914105
- Acronym / sponsor ID
- DOUMU1 / DOUMU1 (29BRC19.0039)
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- 25 Feb 2020 (actual)
- Study completion
- 25 Feb 2020 (actual)
- First posted
- 16 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Without music | Active comparator | Procedure: Without musicTest without music |
| With music | Experimental | Procedure: With music |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Without musicThe 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. | Procedure or surgery | Without music |
| With musicThe 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. | Procedure or surgery | With music |
Primary outcome
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.
6 secondary outcomes
Average VAS of the subject over the period P1
Time frame: 2 minutes
Average VAS of the subject over the period P2
Time frame: 2 minutes
Average VAS of the subject over the period P3
Time frame: 2 minutes
Evaluation of numerical scale
Time frame: 20 minutes
Difference in average VAS P1-P3
Time frame: 20 minutes
Difference in Pressure Pain Threshold (PPT) before and after the procedure
Time frame: 1 hour and 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2021.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gildas L'Heveder, MD study director
Brest University Hospital in France
Céline Bodere, MD principal investigator
Brest University Hospital in France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Without music and With music in people with Pain, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Visual Analogue scale (VAS) (time frame: 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2021.