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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03701971
Recruitment Status : Completed
First Posted : October 10, 2018
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

Study Description
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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
Pruritus Other: evaluation of the intensity of pruritus Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
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 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 : November 8, 2018
Actual Primary Completion Date : April 19, 2019
Actual Study Completion Date : April 19, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Itching

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Variation in the intensity of pruritus [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Hour 0 ]
    Completion of Questionnaire 5D itch scale

  3. To study the impact of pruritic dermatitis on the quality of life of the patient [ Time Frame: Hour 0 ]
    Completion of Questionnaire Itchy Quality of Life

  4. To study the satisfaction of the patients concerning the music session [ Time Frame: Hour 1 ]
    Completion of questionnaire PGIC (Patient's Global Impression of Change)


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03701971


Locations
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France
Brest University Hospital
Brest, France, 29609
Sponsors and Collaborators
University Hospital, Brest
More Information
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Publications:
Chen SJ, Xiao XL, Zhang L. The effect of music therapy on anxiety or depression status of severe male burn patients. J Chin Metallurgical Ind Med. 2005;3:328-329.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT03701971    
Other Study ID Numbers: 29BRC18.0112
First Posted: October 10, 2018    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All collected data that underlie results in a publication
Supporting Materials: 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dermatitis
Pruritus
Skin Diseases
Skin Manifestations