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

Intermunicipal Hospital Center Toulon

Status: Completed

Conditions: Fibromyalgia

Treatments: Other: Relaxation alone; Other: Sound therapy associated with relaxation

Study type: Interventional

Funder types: Other

Identifiers

NCT05237050

2021-CHITS-010

2021-A02461-40 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: Female

Ages: 30 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Sound therapy associated with relaxation

Experimental group

Treatment:

Other: Sound therapy associated with relaxation

Relaxation alone

Active Comparator group

Treatment:

Other: Relaxation alone