Randomized Prospective Open-label Study Evaluating the Benefit of Music Therapy on Pruritus in Patients With Pruritic Dermatitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Variation in the intensity of pruritus
研究概览
简要总结
Many clinical studies have shown the benefit of music therapy in various pathologies, including pain, and it is now established that the latter has a complementary therapeutic interest. Its most frequently identified indications are the fight against acute or chronic pains, the reduction of anxiety, depression and stress, as well as memory disorders such as Alzheimer's disease.
The main modes of action of music therapy involve sensory, cognitive, psychological and behavioral processes that are also found in pruritus.
Pruritus is defined as "an uncomfortable sensation causing the need to scratch. It has similarities with pain but also differences: relief by heat / cold, scratching / withdrawal behavior, localization on the skin, semi-mucous / ubiquitous ... etc.
The pathophysiology also has similarities, pruritus is born at the dermal-epidermal junction at the level of specific cutaneous receptors then follows the classical pathways through a 1st neuron, then the dorsal horn of the spinal cord and a second neuron. At the cerebral level, there is no single center of pruritus but several motor and sensory areas involved.
The similarities suggest that music therapy may have an interest in the management of chronic pruritus, especially since classical treatments (antihistamines, topical corticosteroids) have only partial efficacy in some dermatoses
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years of age
- •Patient with pruritic dermatosis whatever the etiology (psoriasis, atopic dermatitis, toxiderma, cutaneous lymphoma, chronic urticaria ...)
- •Hospitalized in continuous hospitalization in the Dermatology Department
- •Age of dermatosis ≥ 1 month
- •Pruritus score ≥ 3/10 by numerical evaluation
- •Patient having signed a consent form
排除标准
- •Patient under the age of 18
- •Major impairment of hearing function
- •Presence of major cognitive disorders
- •Refusal to participate
- •Pregnant or lactating women
- •Institutionalized or emergency patients
- •Patient under legal protection regime
- •Patient not affiliated to the social security system
研究组 & 干预措施
Music Therapy
- a medical examination
- Before and after music therapy, patients will have to answer questionnaires :
Before :
Questionnaire 5D itch scale Itchy Quality of Life Pruritus assessment on the digital scale Questionnaire State-Trait Anxiety Inventory (STAI Y-A)
After :
Pruritus assessment on the digital scale Questionnaire State-Trait Anxiety Inventory (STAI Y-A) PGIC
• Patients will then benefit from a balneotherapy session the next morning. Patients will have to answer questionnaires before and after balneotherapy :
Before :
Pruritus assessment on the digital scale Questionnaire State-Trait Anxiety Inventory (STAI Y-A)
After :
Pruritus assessment on the digital scale Questionnaire State-Trait Anxiety Inventory (STAI Y-A) PGIC
干预措施: evaluation of the intensity of pruritus (Other)
Emollient cream
- a medical examination
- Before and after music therapy, patients will have to answer questionnaires :
Before :
- Questionnaire 5D itch scale
- Itchy Quality of Life
- Pruritus assessment on the digital scale
- Questionnaire State-Trait Anxiety Inventory (STAI Y-A)
After :
-
Pruritus assessment on the digital scale
-
Questionnaire State-Trait Anxiety Inventory (STAI Y-A)
-
PGIC
-
Patients will then benefit from a balneotherapy session the next morning. Patients will have to answer questionnaires before and after balneotherapy :
Before :
- Pruritus assessment on the digital scale
- Questionnaire State-Trait Anxiety Inventory (STAI Y-A)
After :
- Pruritus assessment on the digital scale
- Questionnaire State-Trait Anxiety Inventory (STAI Y-A)
- PGIC
干预措施: evaluation of the intensity of pruritus (Other)
结局指标
主要结局
Variation in the intensity of pruritus
时间窗: Hour 0 / Hour 1
Variation in the intensity of pruritus on the digital scale of pruritus
次要结局
- To study the effect of music therapy on the patient's anxiety(Hour 0 / Hour 1)
- To study the effect of music therapy according to the etiology of pruritus(Hour 0)
- To study the impact of pruritic dermatitis on the quality of life of the patient(Hour 0)
- To study the satisfaction of the patients concerning the music session(Hour 1)