NCT05237050

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer · Academic / Other
• Sex: Female
• Age: 30 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fibromyalgia

Interventions

Type	Name	Description
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.
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).

Timeline

• Start date: 2022-05-23
• Primary completion: 2022-09-16
• Completion: 2022-09-16
• First posted: 2022-02-11
• Last updated: 2026-04-13

Locations

1 site across 1 country: France