Clinical trial NCT05237050: Evaluation of Sound Therapy in a Population of Women With Fibromyalgia Aged Between 30 and 60 Years
Official title: Evaluation of Sound Therapy in a Population of Women With Fibromyalgia Aged Between 30 and 60 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: Fibromyalgia
Chronic pain
Sound therapy
Tuning fork
Lead sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Sponsor class: OTHER
First posted: 2022-02-11
Enrollment: 40
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Pain intensity according to a Visual Analogic Scale (VAS)
timeFrame: Up to 4 weeks
Secondary outcomes:
measure: Impact on quality of life by Fibromyalgia Impact Questionnaire (FIQ)
timeFrame: Up to 4 weeks
measure: Anxiety assessed by State Trait Anxiety Inventory questionnaire (STAI)
timeFrame: Up to 4 weeks
measure: Qualitative assessment scale of the fluency of consciousness (EQFC)
timeFrame: Up to 4 weeks
measure: Experiential phenomenological interviews
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Gap
country: France
facility: Gap Hospital
state: Hautes Alpes
Study officials:
affiliation: Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
name: Manuel DIAS ALVES, MD
role: STUDY_DIRECTOR
References: