Chronic PainNCT01020032
Effect of Music Therapy on Pain
A study testing Individual receptive music therapy by "U sequence" method in people with Chronic Pain, run by Association de Musicothérapie Applications et Recherches Cliniques at 1 site in France.
Trial summary
The aim of study is to assess the effects of this new music therapy technique on pain treatment, anxiety and depression and on medicinal consumption. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Individual receptive music therapy by "U sequence" method
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2006to Dec 2008
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a pain for more than 6 months
- Pain of neurological origin (fibromyalgia, algodystrophies), or skeletal musculous (back, sciatic nerve)
- Speak and read French fluently
- Wrote consent of patients
- Benefit from the standard treatment : Intravenous treatment (tranquillizer, antidepressive) the first 5 days, 2 time by day (in the morning and evening), followed by the intermediary orally up to the exit (prescribed doses and at request)
Who cannot join
- Time of hospitalization < 8 days
- Reflex epilepsy history
- Major insufficiency of auditory function
- Patient with a strong possibility of not compliance to the protocol or of abandon in the course of study
- Presence of an illness threatening vital forecast during period envisaged for the study
Trial locations and contacts
1 site in 1 country.
France1 site
CHRU Saint Eloi, Centre d'Evaluation et du Traitement de la Douleur
Montpellier, 34295
About this study
Official title: Effect of Music Therapy on Chronic Pain in Hospitalized Patients in a Pain Center
The aim of study is to assess the effects of this new music therapy technique on pain treatment, anxiety and depression and on medicinal consumption.
Read the detailed description
The "U" technique is a music therapy method of recent use developed by taking into account recommendations of the scientific literature. The objective of the study is to evaluate this method on chronic painful patients presenting a lumbago, a fibromyalgia, an inflammatory or neurological pathology. During the hospitalization, the intervention group benefited from at least 2 daily sessions of music therapy between day 0 and day 10, and continued the musicotherapy at home until day 60. The evaluated criteria are pain, depression and anxiety and their evolution after 60 days of treatment (since the inclusion). The evaluation at day 90 allows to test the persistence of the effect of the music therapy 90 days later.
- Conditions
- Chronic Pain
- Being tested
- Individual receptive music therapy by "U sequence" method
- Keywords
- Music therapy, Pain, Anxiety, Depression, Controlled randomized trial
- Medical subject headings
- Chronic Pain, Pain, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual receptive music therapy by "U sequence" methodOther
During the hospitalization, the intervention group benefited from at least 2 daily sessions of music therapy between day 0 and day 10, and continued the musicotherapy at home until day 60.
| Study group | Role | What they receive |
|---|---|---|
| Music therapy | Experimental | Individual receptive music therapy by "U sequence" method Receives: Other: Individual receptive music therapy by "U sequence" method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score on a Visual Analogical Scale (VAS) for actual pain
Measured: Day 0, day 5, day 10, day 60 and day 90
Secondary outcomes (2)
Score on the Hospital Anxiety and Depression (HAD) Scale
Measured: Day 0, day 5, day 10, day 60 and day 90
Medicinal consumption
Measured: Before hospitalization, day 0, day 5, day 10, day 60 and day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2009 (estimated)
- Study startSep 2006
- Primary completionNov 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association de Musicothérapie Applications et Recherches Cliniques
- Sponsor type
- University, hospital or other
- Collaborators
- Centre d'Evaluation et du Traitement de la Douleur CHU Saint-Eloi, Unité de Recherche Clinique et Epidémiologie (DIM) CHU Arnaud de Villeneuve, Centre Mémoire de Ressource et de Recherche équipe INSERM U888 CHU Montpellier
- Investigators
- Stéphane GUETIN, PhD, Principal investigator, Association de Musicothérapie Applications et Recherches Cliniques
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01020032
- Sponsor's protocol ID
- AMARC 200801
- Status last verified
- Nov 2009
- First submitted
- 23 Nov 2009
- Last updated
- 25 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Roy M, Peretz I, Rainville P. Emotional valence contributes to music-induced analgesia. Pain. 2008 Jan;134(1-2):140-7. doi: 10.1016/j.pain.2007.04.003. Epub 2007 May 25.
PubMed 17532141Cepeda MS, Carr DB, Lau J, Alvarez H. Music for pain relief. Cochrane Database Syst Rev. 2006 Apr 19;(2):CD004843. doi: 10.1002/14651858.CD004843.pub2.
PubMed 16625614Guetin S, Portet F, Picot MC, Pommie C, Messaoudi M, Djabelkir L, Olsen AL, Cano MM, Lecourt E, Touchon J. Effect of music therapy on anxiety and depression in patients with Alzheimer's type dementia: randomised, controlled study. Dement Geriatr Cogn Disord. 2009;28(1):36-46. doi: 10.1159/000229024. Epub 2009 Jul 23.
PubMed 19628939
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Music Therapy on Chronic Pain in Hospitalized Patients in a Pain Center
- ClinicalTrials.gov ID
- NCT01020032
- Acronym / sponsor ID
- AMARC 200801
- Conditions
- Chronic Pain
- Keywords
- Music therapy, Pain, Anxiety, Depression, Controlled randomized trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Association de Musicothérapie Applications et Recherches CliniquesUniversity, hospital or other
- Collaborators
- Centre d'Evaluation et du Traitement de la Douleur CHU Saint-Eloi, Unité de Recherche Clinique et Epidémiologie (DIM) CHU Arnaud de Villeneuve, Centre Mémoire de Ressource et de Recherche équipe INSERM U888 CHU Montpellier
- Study start
- Sep 2006
- Primary completion
- Nov 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 25 Nov 2009 (estimated)
- 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 aim of study is to assess the effects of this new music therapy technique on pain treatment, anxiety and depression and on medicinal consumption.
Detailed description
The "U" technique is a music therapy method of recent use developed by taking into account recommendations of the scientific literature. The objective of the study is to evaluate this method on chronic painful patients presenting a lumbago, a fibromyalgia, an inflammatory or neurological pathology. During the hospitalization, the intervention group benefited from at least 2 daily sessions of music therapy between day 0 and day 10, and continued the musicotherapy at home until day 60. The evaluated criteria are pain, depression and anxiety and their evolution after 60 days of treatment (since the inclusion). The evaluation at day 90 allows to test the persistence of the effect of the music therapy 90 days later.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Music therapy | Experimental | Other: Individual receptive music therapy by "U sequence" methodIndividual receptive music therapy by "U sequence" method |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Have a pain for more than 6 months
- Pain of neurological origin (fibromyalgia, algodystrophies), or skeletal musculous (back, sciatic nerve)
- Speak and read French fluently
- Wrote consent of patients
- Benefit from the standard treatment : Intravenous treatment (tranquillizer, antidepressive) the first 5 days, 2 time by day (in the morning and evening), followed by the intermediary orally up to the exit (prescribed doses and at request)
Key exclusion criteria (5 listed)
- Time of hospitalization < 8 days
- Reflex epilepsy history
- Major insufficiency of auditory function
- Patient with a strong possibility of not compliance to the protocol or of abandon in the course of study
- Presence of an illness threatening vital forecast during period envisaged for the study
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 |
|---|---|---|
| Individual receptive music therapy by "U sequence" methodDuring the hospitalization, the intervention group benefited from at least 2 daily sessions of music therapy between day 0 and day 10, and continued the musicotherapy at home until day 60. | Other | Music therapy |
Primary outcome
Score on a Visual Analogical Scale (VAS) for actual pain
Time frame: Day 0, day 5, day 10, day 60 and day 90
2 secondary outcomes
Score on the Hospital Anxiety and Depression (HAD) Scale
Time frame: Day 0, day 5, day 10, day 60 and day 90
Medicinal consumption
Time frame: Before hospitalization, day 0, day 5, day 10, day 60 and day 90
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 25 Nov 2009.
- Background: PubMed 17532141Roy M, Peretz I, Rainville P. Emotional valence contributes to music-induced analgesia. Pain. 2008 Jan;134(1-2):140-7. doi: 10.1016/j.pain.2007.04.003. Epub 2007 May 25.
- Background: PubMed 16625614Cepeda MS, Carr DB, Lau J, Alvarez H. Music for pain relief. Cochrane Database Syst Rev. 2006 Apr 19;(2):CD004843. doi: 10.1002/14651858.CD004843.pub2.
- Background: PubMed 19628939Guetin S, Portet F, Picot MC, Pommie C, Messaoudi M, Djabelkir L, Olsen AL, Cano MM, Lecourt E, Touchon J. Effect of music therapy on anxiety and depression in patients with Alzheimer's type dementia: randomised, controlled study. Dement Geriatr Cogn Disord. 2009;28(1):36-46. doi: 10.1159/000229024. Epub 2009 Jul 23.
- AMARC association is specialized in applications and clinical researches in music therapyLink provided by the sponsor.
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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.
Stéphane GUETIN, PhD principal investigator
Association de Musicothérapie Applications et Recherches Cliniques
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individual receptive music therapy by "U sequence" method in people with Chronic Pain, run by Association de Musicothérapie Applications et Recherches Cliniques 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 5 inclusion and 5 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 25 Nov 2009. 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?
Score on a Visual Analogical Scale (VAS) for actual pain (time frame: Day 0, day 5, day 10, day 60 and day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01020032, which also lists 3 linked publications.
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 25 Nov 2009.