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

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Sound therapy associated with relaxation
Relaxation alone
Sponsored by
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Fibromyalgia focused on measuring Fibromyalgia, Chronic pain, Sound therapy, Tuning fork

Eligibility Criteria

30 Years - 60 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • Gap Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sound therapy associated with relaxation

Relaxation alone

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
February 2, 2022
Last Updated
October 23, 2023
Sponsor
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
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1. Study Identification

Unique Protocol Identification Number
NCT05237050
Brief Title
Evaluation of Sound Therapy in a Population of Women With Fibromyalgia Aged Between 30 and 60 Years
Acronym
SONOMYAL
Official Title
Evaluation of Sound Therapy in a Population of Women With Fibromyalgia Aged Between 30 and 60 Years
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
May 23, 2022 (Actual)
Primary Completion Date
September 16, 2022 (Actual)
Study Completion Date
September 16, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Fibromyalgia, Chronic pain, Sound therapy, Tuning fork

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sound therapy associated with relaxation
Arm Type
Experimental
Arm Title
Relaxation alone
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Sound therapy associated with relaxation
Intervention Description
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
Intervention Name(s)
Relaxation alone
Intervention Description
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 Outcome Measure Information:
Title
Pain intensity according to a Visual Analogic Scale (VAS)
Description
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.
Time Frame
Up to 4 weeks
Secondary Outcome Measure Information:
Title
Impact on quality of life by Fibromyalgia Impact Questionnaire (FIQ)
Description
For this questionnaire, the score is between 0 and 100. A higher score indicates more impact of the condition on patient life.
Time Frame
Up to 4 weeks
Title
Anxiety assessed by State Trait Anxiety Inventory questionnaire (STAI)
Description
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.
Time Frame
Up to 4 weeks
Title
Qualitative assessment scale of the fluency of consciousness (EQFC)
Description
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.
Time Frame
Up to 4 weeks
Title
Experiential phenomenological interviews
Description
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.
Time Frame
4 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manuel DIAS ALVES, MD
Organizational Affiliation
Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
Official's Role
Study Director
Facility Information:
Facility Name
Gap Hospital
City
Gap
State/Province
Hautes Alpes
ZIP/Postal Code
5000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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

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