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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
40
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.
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).
Gap Hospital
Gap, Hautes Alpes, France
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.
Time frame: Up to 4 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 4 weeks
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