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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03701971
Other study ID # 29BRC18.0112
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 8, 2018
Est. completion date April 19, 2019

Study information

Verified date August 2019
Source University Hospital, Brest
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date April 19, 2019
Est. primary completion date April 19, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
France Brest University Hospital Brest

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

References & Publications (34)

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. — View Citation

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. — View Citation

Cepeda MS, Carr DB, Lau J, Alvarez H. Music for pain relief. Cochrane Database Syst Rev. 2006 Apr 19;(2):CD004843. Review. Update in: Cochrane Database Syst Rev. 2013;10:CD004843. — View Citation

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.

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. — View Citation

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. Review. — View Citation

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. Epub 2006 Mar 15. — View Citation

Gold C, Wigram T, Elefant C. Music therapy for autistic spectrum disorder. Cochrane Database Syst Rev. 2006 Apr 19;(2):CD004381. Review. Update in: Cochrane Database Syst Rev. 2014;6:CD004381. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum in: J Pain Symptom Manage. 2014 Dec;48(6):1279. — View Citation

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. — View Citation

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):539-47. doi: 10.1016/j.pain.2012.12.016. Epub 2012 Dec 28. — View Citation

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

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. Review. Erratum in: Lancet. 2015 Oct 24;386(10004):1630. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. French. — View Citation

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

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. Review. — View Citation

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

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. — View Citation

Seccareccia D, Gebara N. Pruritus in palliative care: Getting up to scratch. Can Fam Physician. 2011 Sep;57(9):1010-3, e316-9. English, French. — View Citation

Standley JM. Music research in medical/dental treatment: meta-analysis and clinical applications. J Music Ther. 1986 Summer;23(2):56-122. Review. — View Citation

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. — View Citation

Tarikci N, Kocatürk E, Güngör S, Topal IO, Can PÜ, 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. Review. — View Citation

Vink AC, Birks JS, Bruinsma MS, Scholten RJ. Music therapy for people with dementia. Cochrane Database Syst Rev. 2004;(3):CD003477. Review. Update in: Cochrane Database Syst Rev. 2017 May 02;5:CD003477. — View Citation

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, Ständer S. European guideline on chronic pruritus. Acta Derm Venereol. 2012 Sep;92(5):563-81. doi: 10.2340/00015555-1400. — View Citation

* Note: There are 34 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Variation in the intensity of pruritus Variation in the intensity of pruritus on the digital scale of pruritus Hour 0 / Hour 1
Secondary To study the effect of music therapy on the patient's anxiety Completion of questionnaire State-Trait Anxiety Inventory (STAI Y-A) Hour 0 / Hour 1
Secondary To study the effect of music therapy according to the etiology of pruritus Completion of Questionnaire 5D itch scale Hour 0
Secondary To study the impact of pruritic dermatitis on the quality of life of the patient Completion of Questionnaire Itchy Quality of Life Hour 0
Secondary To study the satisfaction of the patients concerning the music session Completion of questionnaire PGIC (Patient's Global Impression of Change) Hour 1
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