Evaluation of Sound Therapy in a Population of Women With Fibromyalgia Aged Between 30 and 60 Years
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Pain intensity according to a Visual Analogic Scale (VAS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Sound therapy associated with relaxation
干预措施: Sound therapy associated with relaxation (Other)
Relaxation alone
干预措施: Relaxation alone (Other)
结局指标
主要结局
Pain intensity according to a Visual Analogic Scale (VAS)
时间窗: 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.
次要结局
- 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)