Evaluation of Sound Therapy in a Population of Women With Fibromyalgia Aged Between 30 and 60 Years
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Pain intensity according to a Visual Analogic Scale (VAS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to 60 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Sound therapy associated with relaxation
Intervention: Sound therapy associated with relaxation (Other)
Relaxation alone
Intervention: Relaxation alone (Other)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Impact on quality of life by Fibromyalgia Impact Questionnaire (FIQ)(Up to 4 weeks)
- Anxiety assessed by State Trait Anxiety Inventory questionnaire (STAI)(Up to 4 weeks)
- Experiential phenomenological interviews(4 weeks)
- Qualitative assessment scale of the fluency of consciousness (EQFC)(Up to 4 weeks)