PruritusPRURI-MUSICNCT03701971

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

A study testing evaluation of the intensity of pruritus in people with Pruritus, run by University Hospital, Brest at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Pruritus
What is being tested?: evaluation of the intensity of pruritus
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteFrance
Study dates: 8 Nov 2018to 19 Apr 2019
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

France1 site

Brest University Hospital
Brest, 29609

Other trials in France

About this study

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

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
Being tested: evaluation of the intensity of pruritus
Medical subject headings: Pruritus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

evaluation of the intensity of pruritusOther
evaluation of the intensity of pruritus with various questionnaires

Study groups in NCT03701971
Study group	Role	What they receive
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 Receives: 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 Receives: Other: evaluation of the intensity of pruritus

What is being measured

The primary outcome is the main question the study is designed to answer.

Variation in the intensity of pruritus
Variation in the intensity of pruritus on the digital scale of pruritus
Measured: Hour 0 / Hour 1

Secondary outcomes (4)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Nov 201819 Apr 2019

First posted10 Oct 2018
Study start8 Nov 2018
Primary completion19 Apr 2019
Study completion19 Apr 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (35)Papers the sponsor has linked to this study.
Other trials for PruritusStudies of the same condition, open and under way.
More trials run by University Hospital, BrestThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
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)
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03701971
Sponsor's protocol ID: 29BRC18.0112
Acronym: PRURI-MUSIC
Status last verified: Aug 2019
First submitted: 27 Sep 2018
Last updated: 28 Aug 2019
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: All collected data that underlie results in a publication

Publications

Nowak D, Yeung J. Diagnostic et traitement du prurit. Can Fam Physician. 2017 Dec;63(12):925-931. French.
PubMed 29237631
Leibovici V, Magora F, Cohen S, Ingber A. Effects of virtual reality immersion and audiovisual distraction techniques for patients with pruritus. Pain Res Manag. 2009 Jul-Aug;14(4):283-6. doi: 10.1155/2009/178751.
PubMed 19714267
Elmariah SB, Lerner EA. Topical therapies for pruritus. Semin Cutan Med Surg. 2011 Jun;30(2):118-26. doi: 10.1016/j.sder.2011.04.008.
PubMed 21767774
Misery L. [Pruritus: considerable progress in pathophysiology]. Med Sci (Paris). 2014 Dec;30(12):1123-8. doi: 10.1051/medsci/20143012015. Epub 2014 Dec 24. French.
PubMed 25537042
Rossetti A, Chadha M, Torres BN, Lee JK, Hylton D, Loewy JV, Harrison LB. The Impact of Music Therapy on Anxiety in Cancer Patients Undergoing Simulation for Radiation Therapy. Int J Radiat Oncol Biol Phys. 2017 Sep 1;99(1):103-110. doi: 10.1016/j.ijrobp.2017.05.003. Epub 2017 May 8.
PubMed 28816136
Hartling L, Newton AS, Liang Y, Jou H, Hewson K, Klassen TP, Curtis S. Music to reduce pain and distress in the pediatric emergency department: a randomized clinical trial. JAMA Pediatr. 2013 Sep;167(9):826-35. doi: 10.1001/jamapediatrics.2013.200.
PubMed 23857075
Gold C, Wigram T, Elefant C. Music therapy for autistic spectrum disorder. Cochrane Database Syst Rev. 2006 Apr 19;(2):CD004381. doi: 10.1002/14651858.CD004381.pub2.
PubMed 16625601
Vink AC, Birks JS, Bruinsma MS, Scholten RJ. Music therapy for people with dementia. Cochrane Database Syst Rev. 2004;(3):CD003477. doi: 10.1002/14651858.CD003477.pub2.
PubMed 15266489
Cepeda MS, Carr DB, Lau J, Alvarez H. Music for pain relief. Cochrane Database Syst Rev. 2006 Apr 19;(2):CD004843. doi: 10.1002/14651858.CD004843.pub2.
PubMed 16625614
Good M, Anderson GC, Ahn S, Cong X, Stanton-Hicks M. Relaxation and music reduce pain following intestinal surgery. Res Nurs Health. 2005 Jun;28(3):240-51. doi: 10.1002/nur.20076.
PubMed 15884029
Good M, Picot BL, Salem SG, Chin CC, Picot SF, Lane D. Cultural differences in music chosen for pain relief. J Holist Nurs. 2000 Sep;18(3):245-60. doi: 10.1177/089801010001800306.
PubMed 11847812
Burrai F, Micheluzzi V, Zito MP, Pietro G, Sisti D. Effects of live saxophone music on physiological parameters, pain, mood and itching levels in patients undergoing haemodialysis. J Ren Care. 2014 Dec;40(4):249-56. doi: 10.1111/jorc.12078. Epub 2014 Jul 1.
PubMed 24980265
Gutgsell KJ, Schluchter M, Margevicius S, DeGolia PA, McLaughlin B, Harris M, Mecklenburg J, Wiencek C. Music therapy reduces pain in palliative care patients: a randomized controlled trial. J Pain Symptom Manage. 2013 May;45(5):822-31. doi: 10.1016/j.jpainsymman.2012.05.008. Epub 2012 Sep 24.
PubMed 23017609
Kahloul M, Mhamdi S, Nakhli MS, Sfeyhi AN, Azzaza M, Chaouch A, Naija W. Effects of music therapy under general anesthesia in patients undergoing abdominal surgery. Libyan J Med. 2017 Dec;12(1):1260886. doi: 10.1080/19932820.2017.1260886.
PubMed 28452603
Lesiuk T. The Effect of Mindfulness-Based Music Therapy on Attention and Mood in Women Receiving Adjuvant Chemotherapy for Breast Cancer: A Pilot Study. Oncol Nurs Forum. 2015 May;42(3):276-82. doi: 10.1188/15.ONF.276-282.
PubMed 25901379

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Investigation of the Effects of Sleep Deprivation on Itch and Pain Sensitivity
Histamine, Cowhage
Active, not recruiting
Identification of the Mechanism of Non-histaminergic Itch Inducing Epigenetic Changes
Itch
Recruiting
Investigate the Relationship Between Catastrophizing and the Perception of Itch Intensity in Healthy Individuals
Histamine, Cowhage
RecruitingPhase 3
Roflumilast Cream 0.3% for Moderate to Severe Atopic Dermatitis
Atopic Dermatitis, Atopic Dermatitis (AD)
Recruiting
Topographical Distribution of Itch and Pain Receptors
Pain, Itch

All Pruritus trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Prospective Open-label Study Evaluating the Benefit of Music Therapy on Pruritus in Patients With Pruritic Dermatitis
ClinicalTrials.gov ID: NCT03701971
Acronym / sponsor ID: PRURI-MUSIC / 29BRC18.0112
Conditions: Pruritus
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: University Hospital, BrestUniversity, hospital or other
Study start: 8 Nov 2018 (actual)
Primary completion: 19 Apr 2019 (actual)
Study completion: 19 Apr 2019 (actual)
First posted: 10 Oct 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The main modes of action of music therapy involve sensory, cognitive, psychological and behavioral processes that are also found in pruritus.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: evaluation of the benefit of music therapy on pruritus in patients with pruritic dermatitis compared to the application of an emollient

Arm	Type	Receives
Music Therapy	Experimental	Other: evaluation of the intensity of pruritus* 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
Emollient cream	Active comparator	Other: evaluation of the intensity of pruritus* 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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (8 listed)

Patient under the age of 18
Major impairment of hearing function
Presence of major cognitive disorders
Refusal to participate
Pregnant or lactating women

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
evaluation of the intensity of pruritusevaluation of the intensity of pruritus with various questionnaires	Other	Emollient cream, Music Therapy

Primary outcome

Variation in the intensity of pruritus
Time frame: Hour 0 / Hour 1
Variation in the intensity of pruritus on the digital scale of pruritus

4 secondary outcomes

To study the effect of music therapy on the patient's anxiety
Time frame: Hour 0 / Hour 1
To study the effect of music therapy according to the etiology of pruritus
Time frame: Hour 0
To study the impact of pruritic dermatitis on the quality of life of the patient
Time frame: Hour 0
To study the satisfaction of the patients concerning the music session
Time frame: Hour 1

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
Background: PubMed 29237631Nowak D, Yeung J. Diagnostic et traitement du prurit. Can Fam Physician. 2017 Dec;63(12):925-931. French.
Background: PubMed 19714267Leibovici V, Magora F, Cohen S, Ingber A. Effects of virtual reality immersion and audiovisual distraction techniques for patients with pruritus. Pain Res Manag. 2009 Jul-Aug;14(4):283-6. doi: 10.1155/2009/178751.
Background: PubMed 21767774Elmariah SB, Lerner EA. Topical therapies for pruritus. Semin Cutan Med Surg. 2011 Jun;30(2):118-26. doi: 10.1016/j.sder.2011.04.008.
Background: PubMed 25537042Misery L. [Pruritus: considerable progress in pathophysiology]. Med Sci (Paris). 2014 Dec;30(12):1123-8. doi: 10.1051/medsci/20143012015. Epub 2014 Dec 24. French.
Background: PubMed 28816136Rossetti A, Chadha M, Torres BN, Lee JK, Hylton D, Loewy JV, Harrison LB. The Impact of Music Therapy on Anxiety in Cancer Patients Undergoing Simulation for Radiation Therapy. Int J Radiat Oncol Biol Phys. 2017 Sep 1;99(1):103-110. doi: 10.1016/j.ijrobp.2017.05.003. Epub 2017 May 8.
Background: PubMed 23857075Hartling L, Newton AS, Liang Y, Jou H, Hewson K, Klassen TP, Curtis S. Music to reduce pain and distress in the pediatric emergency department: a randomized clinical trial. JAMA Pediatr. 2013 Sep;167(9):826-35. doi: 10.1001/jamapediatrics.2013.200.
Background: PubMed 16625601Gold C, Wigram T, Elefant C. Music therapy for autistic spectrum disorder. Cochrane Database Syst Rev. 2006 Apr 19;(2):CD004381. doi: 10.1002/14651858.CD004381.pub2.
Background: PubMed 15266489Vink AC, Birks JS, Bruinsma MS, Scholten RJ. Music therapy for people with dementia. Cochrane Database Syst Rev. 2004;(3):CD003477. doi: 10.1002/14651858.CD003477.pub2.
Background: PubMed 16625614Cepeda MS, Carr DB, Lau J, Alvarez H. Music for pain relief. Cochrane Database Syst Rev. 2006 Apr 19;(2):CD004843. doi: 10.1002/14651858.CD004843.pub2.
Background: PubMed 15884029Good M, Anderson GC, Ahn S, Cong X, Stanton-Hicks M. Relaxation and music reduce pain following intestinal surgery. Res Nurs Health. 2005 Jun;28(3):240-51. doi: 10.1002/nur.20076.
Background: PubMed 11847812Good M, Picot BL, Salem SG, Chin CC, Picot SF, Lane D. Cultural differences in music chosen for pain relief. J Holist Nurs. 2000 Sep;18(3):245-60. doi: 10.1177/089801010001800306.
Background: PubMed 24980265Burrai F, Micheluzzi V, Zito MP, Pietro G, Sisti D. Effects of live saxophone music on physiological parameters, pain, mood and itching levels in patients undergoing haemodialysis. J Ren Care. 2014 Dec;40(4):249-56. doi: 10.1111/jorc.12078. Epub 2014 Jul 1.
Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication

Related trials for Pruritus

Recruiting
Investigation of the Effects of Sleep Deprivation on Itch and Pain Sensitivity
Histamine, Cowhage
Active, not recruiting
Identification of the Mechanism of Non-histaminergic Itch Inducing Epigenetic Changes
Itch
Recruiting
Investigate the Relationship Between Catastrophizing and the Perception of Itch Intensity in Healthy Individuals
Histamine, Cowhage
RecruitingPhase 3
Roflumilast Cream 0.3% for Moderate to Severe Atopic Dermatitis
Atopic Dermatitis, Atopic Dermatitis (AD)
Recruiting
Topographical Distribution of Itch and Pain Receptors
Pain, Itch

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing evaluation of the intensity of pruritus in people with Pruritus, run by University Hospital, Brest at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Variation in the intensity of pruritus (time frame: Hour 0 / Hour 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03701971, which also lists 35 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.