Evaluation of Sound Therapy in a Population of Women With Fibromyalgia Aged Between 30 and 60 Years

Not Applicable

Completed

• Conditions: Fibromyalgia

• Registration Number: NCT05237050
• Lead Sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

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 Timeline

• Study First Submitted: 2022-02-02
• Study First Submitted QC: 2022-02-10
• Study First Posted: 2022-02-11
• Study Start: 2022-05-23
• Primary Completion: 2022-09-16
• Study Completion: 2022-09-16
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-04
• Last Update Posted: 2025-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain intensity according to a Visual Analogic Scale (VAS)	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 Outcome Measures

Name	Time	Method
Impact on quality of life by Fibromyalgia Impact Questionnaire (FIQ)	Up to 4 weeks	For this questionnaire, the score is between 0 and 100. A higher score indicates more impact of the condition on patient life.
Anxiety assessed by State Trait Anxiety Inventory questionnaire (STAI)	Up to 4 weeks	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.
Experiential phenomenological interviews	4 weeks	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.
Qualitative assessment scale of the fluency of consciousness (EQFC)	Up to 4 weeks	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.

Trial Locations

Locations (1)

Gap Hospital; 🇫🇷 Gap, Hautes Alpes, France