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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05315427
Other study ID # PROICM 2021-10 OMS
Secondary ID 2021-A02020-41
Status Completed
Phase
First received
Last updated
Start date May 2, 2022
Est. completion date January 5, 2023

Study information

Verified date February 2023
Source Institut du Cancer de Montpellier - Val d'Aurelle
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this study is to assess the impact of music therapy on the pain of patients cared at the Montpellier Cancer Institute (ICM) for advanced cancer in a palliative situation and requiring full hospitalization or on an outpatient basis.


Description:

Music therapy is a care practice that falls within the field of support, help and accompaniment therapies. Sound, musical and music are the means used to support, maintain or improve a person's physical and mental health. The patients involved in the study are patients cared at the ICM for advanced cancer in a palliative situation and requiring full hospitalization or on an outpatient basis. The aim is to assess the impact of music therapy on the pain of these patients. The patient is proposed to participate in a music therapy session. Before this session, the music therapist will assess the pain and the presence of symptoms with the patient. Following this exchange, she will define the device best suited to his expectations and his needs and will propose his a relaxation session induced by music. After the session the music therapist will assess with the patient the pain and the presence of symptoms. The patient's feelings and satisfaction about this music therapy session as well as his possible wish to participate in another session will also be evaluated.


Recruitment information / eligibility

Status Completed
Enrollment 41
Est. completion date January 5, 2023
Est. primary completion date January 5, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Male/female over 18 years old - Patient cared for at the ICM for advanced cancer followed by the Mobile Palliative and/or Pain Care Team - Patient with pain score >= 3 (cancer related) - Patient who accepts a music therapy session - Patient having expressed his oral non-opposition - Patient able to communicate - Patient affiliated to the French Social Security System. Exclusion Criteria: - Patient with uncorrected hearing loss to normal - Patient under guardianship, curatorship or safeguard of justice

Study Design


Related Conditions & MeSH terms


Intervention

Other:
one music therapy session
Edmonton Symptom Assessment System (ESAS) scale (before and after music therapy session), Numerical pain scale (before and after music therapy session)

Locations

Country Name City State
France Institut du Cancer de Montpellier Montpellier

Sponsors (1)

Lead Sponsor Collaborator
Institut du Cancer de Montpellier - Val d'Aurelle

Country where clinical trial is conducted

France, 

References & Publications (8)

Alcantara-Silva TR, de Freitas-Junior R, Freitas NMA, de Paula Junior W, da Silva DJ, Machado GDP, Ribeiro MKA, Carneiro JP, Soares LR. Music Therapy Reduces Radiotherapy-Induced Fatigue in Patients With Breast or Gynecological Cancer: A Randomized Trial. Integr Cancer Ther. 2018 Sep;17(3):628-635. doi: 10.1177/1534735418757349. Epub 2018 Apr 10. — View Citation

Beck SL. The therapeutic use of music for cancer-related pain. Oncol Nurs Forum. 1991 Nov-Dec;18(8):1327-37. — View Citation

Boyde C, Linden U, Boehm K, Ostermann T. The Use of Music Therapy During the Treatment of Cancer Patients: A Collection of Evidence. Glob Adv Health Med. 2012 Nov;1(5):24-9. doi: 10.7453/gahmj.2012.1.5.009. Epub 2012 Nov 1. — View Citation

Bradt J, Dileo C, Magill L, Teague A. Music interventions for improving psychological and physical outcomes in cancer patients. Cochrane Database Syst Rev. 2016 Aug 15;(8):CD006911. doi: 10.1002/14651858.CD006911.pub3. — View Citation

Huang ST, Good M, Zauszniewski JA. The effectiveness of music in relieving pain in cancer patients: a randomized controlled trial. Int J Nurs Stud. 2010 Nov;47(11):1354-62. doi: 10.1016/j.ijnurstu.2010.03.008. Epub 2010 Apr 18. — View Citation

Krishnaswamy P, Nair S. Effect of Music Therapy on Pain and Anxiety Levels of Cancer Patients: A Pilot Study. Indian J Palliat Care. 2016 Jul-Sep;22(3):307-11. doi: 10.4103/0973-1075.185042. — View Citation

Lesiuk T. The Development of a Mindfulness-Based Music Therapy (MBMT) Program for Women Receiving Adjuvant Chemotherapy for Breast Cancer. Healthcare (Basel). 2016 Aug 9;4(3):53. doi: 10.3390/healthcare4030053. — View Citation

Siedliecki SL, Good M. Effect of music on power, pain, depression and disability. J Adv Nurs. 2006 Jun;54(5):553-62. doi: 10.1111/j.1365-2648.2006.03860.x. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change between before and after music therapy session on patients pain Evolution of pain assessed by a numerical pain scale ranging from 0 to 10 (10 indicating the highest degree of pain) at day 1 (before and after the music therapy session)
Secondary Description of symptom management By the Edmonton Symptom Assessment System scale symptom score. This is a self-assessment scale of the most common symptoms in palliative care:pain, dyspnoea, fatigue, drowsiness, appetite, anxiety, depression, well-being and other possible symptoms. It's a numerical scale ranging from 0 to 10 (with higher scores indicating more severe symptoms).
The Edmonton Symptom Assessment System scale allows to:
Detect the symptoms present, quantify them and follow their evolution
Validate with the patient the symptoms that bother him and that he wishes to be treated as a priority
Communicate quickly between the different professionals involved in the treatment.
at day 1 (before and after the music therapy session)
Secondary Patient wishing a second session of music therapy Proportion of Patient wishing a second session of music therapy at day 1 (after the music therapy session)
Secondary Patient satisfaction of the music therapy session Assessment of the satisfaction of the music therapy session. Assessment made by a numerical scale ranging from 0 to 10 (10 indicating high satisfaction) at day 1 (after the music therapy session)
Secondary Agreement to participate in the study Proportion of patients agreeing to participate among the eligible patients to whom the study was proposed at inclusion
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