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Clinical Trials/NCT05237050
NCT05237050CompletedNot Applicable

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

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer2 sites in 1 country40 target enrollmentStarted: May 23, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
40
Locations
2
Primary Endpoint
Pain intensity according to a Visual Analogic Scale (VAS)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
30 Years to 60 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

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

Arms & Interventions

Sound therapy associated with relaxation

Experimental

Intervention: Sound therapy associated with relaxation (Other)

Relaxation alone

Active Comparator

Intervention: Relaxation alone (Other)

Outcomes

Primary Outcomes

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

  • Impact on quality of life by Fibromyalgia Impact Questionnaire (FIQ)(Up to 4 weeks)
  • Anxiety assessed by State Trait Anxiety Inventory questionnaire (STAI)(Up to 4 weeks)
  • Experiential phenomenological interviews(4 weeks)
  • Qualitative assessment scale of the fluency of consciousness (EQFC)(Up to 4 weeks)

Investigators

Sponsor
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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