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

NCT03701971 | Completed

• 1 other identifier: 29BRC18.0112
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Pruritus

Outcome Measures

Primary Outcomes (1)

• Variation in the intensity of pruritus

  Variation in the intensity of pruritus on the digital scale of pruritus

  Hour 0 / Hour 1

Secondary Outcomes (4)

• 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

Study Arms (2)

Music Therapy

EXPERIMENTAL

* 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

Emollient cream

ACTIVE COMPARATOR

* 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

Interventions

evaluation of the intensity of pruritus OTHER

evaluation of the intensity of pruritus with various questionnaires

Emollient cream; Music Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

Brest University Hospital

Brest, 29609, France

Location

Related Publications (35)

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  PMID: 31838780 DERIVED

MeSH Terms

Conditions

Pruritus

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: evaluation of the benefit of music therapy on pruritus in patients with pruritic dermatitis compared to the application of an emollient

Study Record Dates

• First Submitted: September 27, 2018
• First Posted: October 10, 2018
• Study Start: November 8, 2018
• Primary Completion: April 19, 2019
• Study Completion: April 19, 2019
• Last Updated: August 28, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning after result publication and ending fifteen years following the study completion
• Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

Locations

FR (1)