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

NCT ID: NCT05237050

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-23
• Study Completion Date: 2022-09-16

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.

Conditions

Fibromyalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Sound therapy associated with relaxation

Group Type: EXPERIMENTAL

Sound therapy associated with relaxation

Intervention Type: OTHER

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.

Relaxation alone

Group Type: ACTIVE_COMPARATOR

Relaxation alone

Intervention Type: OTHER

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).

Interventions

Sound therapy associated with relaxation

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.

Intervention Type: OTHER

Relaxation alone

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).

Intervention Type: OTHER

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Manuel DIAS ALVES, MD

Role: STUDY_DIRECTOR

Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

Locations

Gap Hospital

Gap, Hautes Alpes, France

Countries

France

Other Identifiers

2021-A02461-40

Identifier Type: OTHER

Identifier Source: secondary_id

2021-CHITS-010

Identifier Type: -

Identifier Source: org_study_id