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

Primary Purpose

Pruritus

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
evaluation of the intensity of pruritus
Sponsored by
University Hospital, Brest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pruritus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Brest University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Music Therapy

Emollient cream

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 27, 2018
Last Updated
August 27, 2019
Sponsor
University Hospital, Brest
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1. Study Identification

Unique Protocol Identification Number
NCT03701971
Brief Title
Study Evaluating the Benefit of Music Therapy on Pruritus in Patients With Pruritic Dermatitis
Acronym
PRURI-MUSIC
Official Title
Randomized Prospective Open-label Study Evaluating the Benefit of Music Therapy on Pruritus in Patients With Pruritic Dermatitis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
November 8, 2018 (Actual)
Primary Completion Date
April 19, 2019 (Actual)
Study Completion Date
April 19, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pruritus

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Music Therapy
Arm Type
Experimental
Arm Description
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
Arm Title
Emollient cream
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
evaluation of the intensity of pruritus
Intervention Description
evaluation of the intensity of pruritus with various questionnaires
Primary Outcome Measure Information:
Title
Variation in the intensity of pruritus
Description
Variation in the intensity of pruritus on the digital scale of pruritus
Time Frame
Hour 0 / Hour 1
Secondary Outcome Measure Information:
Title
To study the effect of music therapy on the patient's anxiety
Description
Completion of questionnaire State-Trait Anxiety Inventory (STAI Y-A)
Time Frame
Hour 0 / Hour 1
Title
To study the effect of music therapy according to the etiology of pruritus
Description
Completion of Questionnaire 5D itch scale
Time Frame
Hour 0
Title
To study the impact of pruritic dermatitis on the quality of life of the patient
Description
Completion of Questionnaire Itchy Quality of Life
Time Frame
Hour 0
Title
To study the satisfaction of the patients concerning the music session
Description
Completion of questionnaire PGIC (Patient's Global Impression of Change)
Time Frame
Hour 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Brest University Hospital
City
Brest
ZIP/Postal Code
29609
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All collected data that underlie results in a publication
IPD Sharing Time Frame
Data will be available beginning after result publication and ending fifteen years following the study completion
IPD Sharing 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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Study Evaluating the Benefit of Music Therapy on Pruritus in Patients With Pruritic Dermatitis

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