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

NCT ID: NCT03701971

Last Updated: 2019-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-08

Study Completion Date

2019-04-19

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pruritus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

evaluation of the benefit of music therapy on pruritus in patients with pruritic dermatitis compared to the application of an emollient
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

evaluation of the intensity of pruritus

Intervention Type OTHER

evaluation of the intensity of pruritus with various questionnaires

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

Group Type ACTIVE_COMPARATOR

evaluation of the intensity of pruritus

Intervention Type OTHER

evaluation of the intensity of pruritus with various questionnaires

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

evaluation of the intensity of pruritus

evaluation of the intensity of pruritus with various questionnaires

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Brest

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Brest University Hospital

Brest, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

Nowak D, Yeung J. Diagnostic et traitement du prurit. Can Fam Physician. 2017 Dec;63(12):925-931. French.

Reference Type BACKGROUND
PMID: 29237631 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19714267 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21767774 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25537042 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28816136 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23857075 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16625601 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15266489 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16625614 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15884029 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11847812 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24980265 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23017609 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28452603 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25901379 (View on PubMed)

Hole J, Hirsch M, Ball E, Meads C. Music as an aid for postoperative recovery in adults: a systematic review and meta-analysis. Lancet. 2015 Oct 24;386(10004):1659-71. doi: 10.1016/S0140-6736(15)60169-6. Epub 2015 Aug 12.

Reference Type BACKGROUND
PMID: 26277246 (View on PubMed)

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.

Reference Type BACKGROUND

Standley JM. Music research in medical/dental treatment: meta-analysis and clinical applications. J Music Ther. 1986 Summer;23(2):56-122. doi: 10.1093/jmt/23.2.56.

Reference Type BACKGROUND
PMID: 10301218 (View on PubMed)

Hauck M, Metzner S, Rohlffs F, Lorenz J, Engel AK. The influence of music and music therapy on pain-induced neuronal oscillations measured by magnetencephalography. Pain. 2013 Apr;154(4):539-547. doi: 10.1016/j.pain.2012.12.016. Epub 2012 Dec 28.

Reference Type BACKGROUND
PMID: 23414577 (View on PubMed)

Kordovan S, Preissler P, Kamphausen A, Bokemeyer C, Oechsle K. Prospective Study on Music Therapy in Terminally Ill Cancer Patients during Specialized Inpatient Palliative Care. J Palliat Med. 2016 Apr;19(4):394-9. doi: 10.1089/jpm.2015.0384. Epub 2016 Feb 19.

Reference Type BACKGROUND
PMID: 26894922 (View on PubMed)

Gallagher LM, Lagman R, Walsh D, Davis MP, Legrand SB. The clinical effects of music therapy in palliative medicine. Support Care Cancer. 2006 Aug;14(8):859-66. doi: 10.1007/s00520-005-0013-6. Epub 2006 Mar 15.

Reference Type BACKGROUND
PMID: 16538499 (View on PubMed)

Choi S, Park SG, Bellan L, Lee HH, Chung SK. Crossover clinical trial of pain relief in cataract surgery. Int Ophthalmol. 2018 Jun;38(3):1027-1033. doi: 10.1007/s10792-017-0554-y. Epub 2017 Jun 20.

Reference Type BACKGROUND
PMID: 28639089 (View on PubMed)

Hoareau SG, De Diego E, Guetin S. [Pain management and music therapy]. Rev Infirm. 2016 Jan;(217):31-3. doi: 10.1016/j.revinf.2015.10.025. French.

Reference Type BACKGROUND
PMID: 26743370 (View on PubMed)

Bates D, Bolwell B, Majhail NS, Rybicki L, Yurch M, Abounader D, Kohuth J, Jarancik S, Koniarczyk H, McLellan L, Dabney J, Lawrence C, Gallagher L, Kalaycio M, Sobecks R, Dean R, Hill B, Pohlman B, Hamilton BK, Gerds AT, Jagadeesh D, Liu HD. Music Therapy for Symptom Management After Autologous Stem Cell Transplantation: Results From a Randomized Study. Biol Blood Marrow Transplant. 2017 Sep;23(9):1567-1572. doi: 10.1016/j.bbmt.2017.05.015. Epub 2017 May 19.

Reference Type BACKGROUND
PMID: 28533058 (View on PubMed)

Tarikci N, Kocaturk E, Gungor S, Topal IO, Can PU, Singer R. Pruritus in Systemic Diseases: A Review of Etiological Factors and New Treatment Modalities. ScientificWorldJournal. 2015;2015:803752. doi: 10.1155/2015/803752. Epub 2015 Jul 9.

Reference Type BACKGROUND
PMID: 26240837 (View on PubMed)

Hon KL, Pong NH, Wang SS, Lee VW, Luk NM, Leung TF. Acceptability and efficacy of an emollient containing ceramide-precursor lipids and moisturizing factors for atopic dermatitis in pediatric patients. Drugs R D. 2013 Mar;13(1):37-42. doi: 10.1007/s40268-013-0004-x.

Reference Type BACKGROUND
PMID: 23456759 (View on PubMed)

Hon KL, Kung JSC, Ng WGG, Leung TF. Emollient treatment of atopic dermatitis: latest evidence and clinical considerations. Drugs Context. 2018 Apr 17;7:212530. doi: 10.7573/dic.212530. eCollection 2018.

Reference Type BACKGROUND
PMID: 29692852 (View on PubMed)

Jacobi A, Mayer A, Augustin M. Keratolytics and emollients and their role in the therapy of psoriasis: a systematic review. Dermatol Ther (Heidelb). 2015 Mar;5(1):1-18. doi: 10.1007/s13555-015-0068-3. Epub 2015 Jan 21.

Reference Type BACKGROUND
PMID: 25604924 (View on PubMed)

Seccareccia D, Gebara N. Pruritus in palliative care: Getting up to scratch. Can Fam Physician. 2011 Sep;57(9):1010-3, e316-9. No abstract available.

Reference Type BACKGROUND
PMID: 21918143 (View on PubMed)

Goutos I, Clarke M, Upson C, Richardson PM, Ghosh SJ. Review of therapeutic agents for burns pruritus and protocols for management in adult and paediatric patients using the GRADE classification. Indian J Plast Surg. 2010 Sep;43(Suppl):S51-62. doi: 10.4103/0970-0358.70721.

Reference Type BACKGROUND
PMID: 21321658 (View on PubMed)

Moncrieff G, Cork M, Lawton S, Kokiet S, Daly C, Clark C. Use of emollients in dry-skin conditions: consensus statement. Clin Exp Dermatol. 2013 Apr;38(3):231-8; quiz 238. doi: 10.1111/ced.12104.

Reference Type BACKGROUND
PMID: 23517354 (View on PubMed)

Misery L. Itch Management: General Principles. Curr Probl Dermatol. 2016;50:35-9. doi: 10.1159/000446039. Epub 2016 Aug 23.

Reference Type BACKGROUND
PMID: 27578069 (View on PubMed)

Takeuchi S, Oba J, Esaki H, Furue M. Pruritus of patients with atopic dermatitis in daily life and their experience of therapeutic effects: results of a web-based questionnaire survey. Br J Dermatol. 2015 Jul;173(1):250-2. doi: 10.1111/bjd.13557. Epub 2015 Mar 27. No abstract available.

Reference Type BACKGROUND
PMID: 25421804 (View on PubMed)

Weisshaar E, Szepietowski JC, Darsow U, Misery L, Wallengren J, Mettang T, Gieler U, Lotti T, Lambert J, Maisel P, Streit M, Greaves MW, Carmichael AJ, Tschachler E, Ring J, Stander S. European guideline on chronic pruritus. Acta Derm Venereol. 2012 Sep;92(5):563-81. doi: 10.2340/00015555-1400. No abstract available.

Reference Type BACKGROUND
PMID: 22790094 (View on PubMed)

Demirtas S, Houssais C, Tanniou J, Misery L, Brenaut E. Effectiveness of a music intervention on pruritus: an open randomized prospective study. J Eur Acad Dermatol Venereol. 2020 Jun;34(6):1280-1285. doi: 10.1111/jdv.16149. Epub 2020 Jan 14.

Reference Type DERIVED
PMID: 31838780 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

29BRC18.0112

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Music Therapy in Alzheimer's Disease
NCT02020356 TERMINATED NA