Don't get left behind! The modernized ClinicalTrials.gov is coming. Check it out now.
Say goodbye to ClinicalTrials.gov!
The new site is coming soon - go to the modernized ClinicalTrials.gov
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05237050
Recruitment Status : Completed
First Posted : February 11, 2022
Last Update Posted : March 21, 2023
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 Not Applicable

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual 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
Actual Primary Completion Date : September 16, 2022
Actual Study Completion Date : September 16, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 Outcome Measures :
  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.



Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05237050


Locations
Layout table for location information
France
Gap Hospital
Gap, Hautes Alpes, France, 5000
Sponsors and Collaborators
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Investigators
Layout table for investigator information
Study Director: Manuel DIAS ALVES, MD Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
ClinicalTrials.gov Identifier: NCT05237050    
Other Study ID Numbers: 2021-CHITS-010
2021-A02461-40 ( Other Identifier: Id-RCB )
First Posted: February 11, 2022    Key Record Dates
Last Update Posted: March 21, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer:
Fibromyalgia
Chronic pain
Sound therapy
Tuning fork
Additional relevant MeSH terms:
Layout table for MeSH terms
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases