FibromyalgiaSONOMYALNCT05237050
Evaluation of Sound Therapy in a Population of Women With Fibromyalgia Aged Between 30 and 60 Years
A study testing Sound therapy associated with relaxation and Relaxation alone in people with Fibromyalgia, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 1 site in France.
Trial summary
This study focusing on sound therapy in patients with fibromyalgia is a single-centre, prospective, randomized study which evaluates the improvement or not of painful symptoms following relaxation sessions with sound therapy. Read more about this study
- Who is it for?
- Ages 30 to 60 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Sound therapy associated with relaxation and Relaxation alone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 23 May 2022to 16 Sep 2022
- 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 30 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Aged between 30 and 60
- Fibromyalgia diagnosed according to the criteria of the combined Widespread Pain Index (WPI) and the Symptom Severity Scale (SSS) of the American College of Rheumatology ; and this whatever the previous analgesic medication and whatever the symptomatology
- Able to express her consent prior to participation in the study
- Affiliated to or beneficiary of a social security regimen
Who cannot join
- Total deafness in one or both ears (patients with age-related presbycusis can be included)
- Pregnant women
- Patient under judicial protection (guardianship, curatorship...) or safeguard of justice
Trial locations and contacts
1 site in 1 country.
About this study
This study focusing on sound therapy in patients with fibromyalgia is a single-centre, prospective, randomized study which evaluates the improvement or not of painful symptoms following relaxation sessions with sound therapy.
Read the detailed description
Sound therapy consists in sound use as therapy and appears to mitigate or even relieve some symptoms.
The SonoMyal study intends to compare the effects of relaxation sessions with sound therapy delivered by tuning forks to a control group who will benefit from relaxation sessions without tuning fork activation, in a population of women with fibromyalgia.
The treatment consists in one session per week during 3 weeks, for a total of 3 sessions. Questionnaires to assess pain, anxiety and the ability to let go will be completed by patients before the beginning of the first session and at the end of the last session.
The main objective of the study is to assess with a Visual Analogue Scale of pain if 3 relaxation sessions with sound therapy delivered by tuning forks can improve pain perception in patients with fibromyalgia.
- Conditions
- Fibromyalgia
- Being tested
- Sound therapy associated with relaxation, Relaxation alone
- Keywords
- Fibromyalgia, Chronic pain, Sound therapy, Tuning fork
- Medical subject headings
- Fibromyalgia, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sound therapy associated with relaxationOther
Each patient will attend a total of 3 sessions of about 15 minutes each, once by week.
Sessions will start with relaxation. Then, sound therapy will be delivered using weighted medical tuning forks which resonate at a specific frequency. At the end of the session, the patient will be invited to take a short rest.
Relaxation aloneOther
Each patient will attend a total of 3 sessions of about 15 minutes each, once by week.
The procedure will be exactly the same than the other arm (relaxation, rest time), but the operator will not activate any tuning fork (so there will be no sound delivered during the session).
| Study group | Role | What they receive |
|---|---|---|
| Sound therapy associated with relaxation | Experimental | Not described Receives: Other: Sound therapy associated with relaxation |
| Relaxation alone | Active comparator | Not described Receives: Other: Relaxation alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity according to a Visual Analogic Scale (VAS)
The minimum value of the scale, corresponding to no pain at all, is 0 and the maximum value is 10. Pain intensity will be assessed before and after each session and will be compared between the two groups.
Measured: Up to 4 weeks
Secondary outcomes (4)
Impact on quality of life by Fibromyalgia Impact Questionnaire (FIQ)
For this questionnaire, the score is between 0 and 100. A higher score indicates more impact of the condition on patient life.
Measured: Up to 4 weeks
Anxiety assessed by State Trait Anxiety Inventory questionnaire (STAI)
For "State" STAI : the minimum value is 20 and the maximum value is 80. Higher scores mean a worse outcome, high level of anxiety.
For "Trait" STAI : the minimum value is 21 and the maximum 77. Higher scores mean a worse outcome, high level of anxiety.
Measured: Up to 4 weeks
Qualitative assessment scale of the fluency of consciousness (EQFC)
For "State" EQFC : the minimum value is 48 and the maximum value is 80. Higher scores mean a better outcome, high level of fluency.
For "Trait" EQFC : the minimum value is 48 and the maximum value is 80. Higher scores mean a better outcome, high level of fluency.
Measured: Up to 4 weeks
Experiential phenomenological interviews
Only for the group of patients randomized in Arm 1 "Sound therapy associated with relaxation".
Based on guided introspection and allow the description of background experiences of consciousness.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start23 May 2022
- Primary completion16 Sep 2022
- Study completion16 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manuel DIAS ALVES, MD, Study director, Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05237050
- Sponsor's protocol ID
- 2021-CHITS-010
- Other IDs
- 2021-A02461-40
- Acronym
- SONOMYAL
- Status last verified
- Jul 2026
- First submitted
- 2 Feb 2022
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Sound Therapy in a Population of Women With Fibromyalgia Aged Between 30 and 60 Years
- ClinicalTrials.gov ID
- NCT05237050
- Acronym / sponsor ID
- SONOMYAL / 2021-CHITS-010
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Chronic pain, Sound therapy, Tuning fork
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur MerUniversity, hospital or other
- Study start
- 23 May 2022 (actual)
- Primary completion
- 16 Sep 2022 (actual)
- Study completion
- 16 Sep 2022 (actual)
- First posted
- 11 Feb 2022 (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.
This study focusing on sound therapy in patients with fibromyalgia is a single-centre, prospective, randomized study which evaluates the improvement or not of painful symptoms following relaxation sessions with sound therapy.
Detailed description
Sound therapy consists in sound use as therapy and appears to mitigate or even relieve some symptoms.
The SonoMyal study intends to compare the effects of relaxation sessions with sound therapy delivered by tuning forks to a control group who will benefit from relaxation sessions without tuning fork activation, in a population of women with fibromyalgia.
The treatment consists in one session per week during 3 weeks, for a total of 3 sessions. Questionnaires to assess pain, anxiety and the ability to let go will be completed by patients before the beginning of the first session and at the end of the last session.
The main objective of the study is to assess with a Visual Analogue Scale of pain if 3 relaxation sessions with sound therapy delivered by tuning forks can improve pain perception in patients with fibromyalgia.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sound therapy associated with relaxation | Experimental | Other: Sound therapy associated with relaxation |
| Relaxation alone | Active comparator | Other: Relaxation alone |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Aged between 30 and 60
- Fibromyalgia diagnosed according to the criteria of the combined Widespread Pain Index (WPI) and the Symptom Severity Scale (SSS) of the American College of Rheumatology ; and this whatever the previous analgesic medication and whatever the symptomatology
- Able to express her consent prior to participation in the study
- Affiliated to or beneficiary of a social security regimen
Key exclusion criteria (3 listed)
- Total deafness in one or both ears (patients with age-related presbycusis can be included)
- Pregnant women
- Patient under judicial protection (guardianship, curatorship...) or safeguard of justice
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 |
|---|---|---|
| Sound therapy associated with relaxationEach patient will attend a total of 3 sessions of about 15 minutes each, once by week. Sessions will start with relaxation. Then, sound therapy will be delivered using weighted medical tuning forks which resonate at a specific frequency. At the end of the session, the patient will be invited to take a short rest. | Other | Sound therapy associated with relaxation |
| Relaxation aloneEach patient will attend a total of 3 sessions of about 15 minutes each, once by week. The procedure will be exactly the same than the other arm (relaxation, rest time), but the operator will not activate any tuning fork (so there will be no sound delivered during the session). | Other | Relaxation alone |
Primary outcome
Pain intensity according to a Visual Analogic Scale (VAS)
Time frame: Up to 4 weeks
The minimum value of the scale, corresponding to no pain at all, is 0 and the maximum value is 10. Pain intensity will be assessed before and after each session and will be compared between the two groups.
4 secondary outcomes
Impact on quality of life by Fibromyalgia Impact Questionnaire (FIQ)
Time frame: Up to 4 weeks
Anxiety assessed by State Trait Anxiety Inventory questionnaire (STAI)
Time frame: Up to 4 weeks
Qualitative assessment scale of the fluency of consciousness (EQFC)
Time frame: Up to 4 weeks
Experiential phenomenological interviews
Time frame: 4 weeks
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 7 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Manuel DIAS ALVES, MD study director
Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sound therapy associated with relaxation and Relaxation alone in people with Fibromyalgia, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer 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 4 inclusion and 3 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 7 Jul 2026. 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?
Pain intensity according to a Visual Analogic Scale (VAS) (time frame: Up to 4 weeks). 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 7 Jul 2026.