Study Evaluating the Benefit of Music Therapy on Pruritus in Patients With Pruritic Dermatitis

Study Overview
=================
Brief Summary
-----------------
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

Official Title
-----------------
Randomized Prospective Open-label Study Evaluating the Benefit of Music Therapy on Pruritus in Patients With Pruritic Dermatitis

Conditions
-----------------
Pruritus

Intervention / Treatment
-----------------
* Other: evaluation of the intensity of pruritus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: evaluation of the benefit of music therapy on pruritus in patients with pruritic dermatitis compared to the application of an emollient
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Music Therapy<br>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 | Other: evaluation of the intensity of pruritus<br>* evaluation of the intensity of pruritus with various questionnaires<br>|
| Active Comparator: Emollient cream<br>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 | Other: evaluation of the intensity of pruritus<br>* evaluation of the intensity of pruritus with various questionnaires<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation in the intensity of pruritus | Variation in the intensity of pruritus on the digital scale of pruritus | Hour 0 / Hour 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To study the effect of music therapy on the patient's anxiety | Completion of questionnaire State-Trait Anxiety Inventory (STAI Y-A) | Hour 0 / Hour 1 | 
| To study the effect of music therapy according to the etiology of pruritus | Completion of Questionnaire 5D itch scale | Hour 0 | 
| To study the impact of pruritic dermatitis on the quality of life of the patient | Completion of Questionnaire Itchy Quality of Life | Hour 0 | 
| To study the satisfaction of the patients concerning the music session | Completion of questionnaire PGIC (Patient's Global Impression of Change) | Hour 1 |