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

Sponsor

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer (Other)

Overall Status

Recruiting

CT.gov ID

NCT05237050

Collaborator

(none)

Enrollment

Location

Arms

4.3

Anticipated Duration (Months)

9.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fibromyalgia	Other: Sound therapy associated with relaxation Other: Relaxation alone	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

May 23, 2022

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sound therapy associated with relaxation	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.
Active Comparator: Relaxation alone	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).

Arm

Intervention/Treatment

Experimental: Sound therapy associated with relaxation

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.

Active Comparator: Relaxation alone

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).

Outcome Measures

Primary Outcome Measures

Pain intensity according to a Visual Analogic Scale (VAS) [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 Outcome Measures

Impact on quality of life by Fibromyalgia Impact Questionnaire (FIQ) [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.
Anxiety assessed by State Trait Anxiety Inventory questionnaire (STAI) [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.
Qualitative assessment scale of the fluency of consciousness (EQFC) [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.
Experiential phenomenological interviews [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 60 Years

Sexes Eligible for Study:

Female

Accepts 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