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

Fibromyalgia Clinical Trial

— SONOMYAL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05237050
• Other study ID #: 2021-CHITS-010
• Secondary ID: 2021-A02461-40
• Status: Completed
• Phase: N/A
• Start date: May 23, 2022
• Est. completion date: September 16, 2022

Study information

• Verified date: March 2024
• Source: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 16, 2022
• Est. primary completion date: September 16, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Other:
• 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.
• 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).

Locations

Country	Name	City	State
France	Gap Hospital	Gap	Hautes Alpes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Country where clinical trial is conducted

France, 

Outcome

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