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PRURI-MUSIC: Study Evaluating the Benefit of Music Therapy on Pruritus in Patients With Pruritic Dermatitis

Sponsor
University Hospital, Brest (Other)
Overall Status
Completed
CT.gov ID
NCT03701971
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
5.3
Actual Duration (Months)
9.4
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Other: evaluation of the intensity of pruritus
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
evaluation of the benefit of music therapy on pruritus in patients with pruritic dermatitis compared to the application of an emollientevaluation of the benefit of music therapy on pruritus in patients with pruritic dermatitis compared to the application of an emollient
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Randomized Prospective Open-label Study Evaluating the Benefit of Music Therapy on Pruritus in Patients With Pruritic Dermatitis
Actual Study Start Date :
Nov 8, 2018
Actual Primary Completion Date :
Apr 19, 2019
Actual Study Completion Date :
Apr 19, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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

Other: evaluation of the intensity of pruritus
evaluation of the intensity of pruritus with various questionnaires
Active Comparator: 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

Other: evaluation of the intensity of pruritus
evaluation of the intensity of pruritus with various questionnaires

Outcome Measures

Primary Outcome Measures

  1. Variation in the intensity of pruritus [Hour 0 / Hour 1]

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

Secondary Outcome Measures

  1. To study the effect of music therapy on the patient's anxiety [Hour 0 / Hour 1]

    Completion of questionnaire State-Trait Anxiety Inventory (STAI Y-A)

  2. To study the effect of music therapy according to the etiology of pruritus [Hour 0]

    Completion of Questionnaire 5D itch scale

  3. To study the impact of pruritic dermatitis on the quality of life of the patient [Hour 0]

    Completion of Questionnaire Itchy Quality of Life

  4. To study the satisfaction of the patients concerning the music session [Hour 1]

    Completion of questionnaire PGIC (Patient's Global Impression of Change)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Brest University Hospital Brest France 29609

Sponsors and Collaborators

  • University Hospital, Brest

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University Hospital, Brest
ClinicalTrials.gov Identifier:
NCT03701971
Other Study ID Numbers:
  • 29BRC18.0112
First Posted:
Oct 10, 2018
Last Update Posted:
Aug 28, 2019
Last Verified:
Aug 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Dermatitis
Pruritus

Study Results

No Results Posted as of Aug 28, 2019