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NCT Number: NCT05237050

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

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.

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Key information

Conditions

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

Age range

30 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Gap Hospital

Gap, Hautes Alpes, 5000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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).

Primary outcomes

  1. Pain intensity according to a Visual Analogic Scale (VAS)

    Time frame: 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 outcomes

  1. Impact on quality of life by Fibromyalgia Impact Questionnaire (FIQ)

    Time frame: 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.

  2. Anxiety assessed by State Trait Anxiety Inventory questionnaire (STAI)

    Time frame: 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.

  3. Qualitative assessment scale of the fluency of consciousness (EQFC)

    Time frame: 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.

  4. Experiential phenomenological interviews

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Other

Registry information

Acronym: SONOMYAL

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 11, 2022
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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