Ignite Creation Date:
2025-12-24 @ 5:16 PM
Ignite Modification Date:
2025-12-29 @ 3:29 AM
Study NCT ID:
NCT05237050
Status:
COMPLETED
Last Update Posted:
2025-11-20
First Post:
2022-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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
Organization:
Study Overview
Official Title:
Evaluation of Sound Therapy in a Population of Women With Fibromyalgia Aged Between 30 and 60 Years
Status:
COMPLETED
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SONOMYAL
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2021-A02461-40 | OTHER | Id-RCB | View |