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

NCT05237050 | Completed

• 2 other identifiers: 2021-CHITS-0102021-A02461-40
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Keywords

Fibromyalgia; Chronic pain; Sound therapy; Tuning fork

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 4 weeks

Secondary Outcomes (4)

• 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

• Qualitative assessment scale of the fluency of consciousness (EQFC)

  Up to 4 weeks

• Experiential phenomenological interviews

  4 weeks

Study Arms (2)

Sound therapy associated with relaxation

EXPERIMENTAL

Other: Sound therapy associated with relaxation

Relaxation alone

ACTIVE COMPARATOR

Other: Relaxation alone

Interventions

Relaxation alone 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).

Relaxation alone

Sound therapy associated with relaxation 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.

Sound therapy associated with relaxation

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer: lead

Study Sites (1)

Gap Hospital

Gap, Hautes Alpes, 5000, France

Location

MeSH Terms

Conditions

Fibromyalgia; Chronic Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Manuel DIAS ALVES, MD

  Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2022
• First Posted: February 11, 2022
• Study Start: May 23, 2022
• Primary Completion: September 16, 2022
• Study Completion: September 16, 2022
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)