- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05315427
Impact of Music Therapy on Pain in Patients Treated for Advanced Cancer (MSPD)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Montpellier, France, 34298
- Institut du Cancer de Montpellier
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Evaluation of the impact of music therapy on the pain of patients
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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change between before and after music therapy session on patients pain
Time Frame: at day 1 (before and after the music therapy session)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Description of symptom management
Time Frame: at day 1 (before and after the music therapy session)
|
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:
|
at day 1 (before and after the music therapy session)
|
|
Patient wishing a second session of music therapy
Time Frame: at day 1 (after the music therapy session)
|
Proportion of Patient wishing a second session of music therapy
|
at day 1 (after the music therapy session)
|
|
Patient satisfaction of the music therapy session
Time Frame: at day 1 (after 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)
|
|
Agreement to participate in the study
Time Frame: at inclusion
|
Proportion of patients agreeing to participate among the eligible patients to whom the study was proposed
|
at inclusion
|
Collaborators and Investigators
Investigators
- Study Chair: Caroline GALLAY, Institut du Cancer de Montpellier - Val d'aurelle
Publications and helpful links
General Publications
- 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.
- Beck SL. The therapeutic use of music for cancer-related pain. Oncol Nurs Forum. 1991 Nov-Dec;18(8):1327-37.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PROICM 2021-10 OMS
- 2021-A02020-41 (Other Identifier: ID RCB number of competent autority in France)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Advanced Cancer
-
UNICANCERRecruitingAdvanced Breast Cancer | Advanced Gastric Cancer | Advanced Urothelial Cancer | Advanced Non Small Cell Lung Cancer (NSCLC)France
-
Icahn School of Medicine at Mount SinaiNational Institute of Nursing Research (NINR)Not yet recruitingAdvanced Heart Failure | Advanced Lung Cancer | Advanced Triple Negative Breast Cancer | Advanced Non-Colorectal Gastrointestinal CancerUnited States
-
Teon Therapeutics, Inc.Merck Sharp & Dohme LLCTerminatedCancer | Advanced Solid Tumor | Advanced Cancer | OncologyUnited States
-
Zhejiang UniversityRecruitingAdvanced Colorectal Cancer | Advanced Hepatocellular Carcinoma | Advanced Gastric Cancer | Advanced Pancreatic CancerChina
-
STORM Therapeutics LTDCompletedCancer | Advanced Solid Tumor | Advanced CancerUnited States
-
Merck Sharp & Dohme LLCCompletedAdvanced Cancer Relapsed | Advanced Cancer Refractory
-
BiOneCure Therapeutics Inc.RecruitingCancer | Advanced Solid Tumor | Advanced Cancer | OncologyUnited States
-
PfizerRecruitingAdvanced Cancer | Advanced MalignanciesUnited States
-
Shanghai Allink Biotherapeutics Co., Ltd.RecruitingAdvanced Solid Tumor | Advanced CancerAustralia, United States
-
Chinese PLA General HospitalNot yet recruitingTreatment for Advanced Colorectal Cancer | Treatment for Advanced Pancreatic Cancer
Clinical Trials on one music therapy session
-
Beth Israel Medical CenterCompleted
-
Chang Gung Memorial HospitalUnknown
-
Hospices Civils de LyonRecruitingBehavioral Disorder | Music TherapyFrance
-
Yale UniversityHoward University; Renée Fleming Foundation; Yale University School of Medicine... and other collaboratorsEnrolling by invitationDementia | Alzheimer Disease | Mild Cognitive Impairment | Caregiver | Peer-bonded CaregiverUnited States
-
Hebrew University of JerusalemRecruiting
-
Yale UniversityNational Center for Complementary and Integrative Health (NCCIH); Howard University and other collaboratorsRecruitingDementia | Alzheimer Disease | Mild Cognitive Impairment | Caregiver | Peer-bonded CaregiverUnited States
-
Chelsea and Westminster NHS Foundation TrustImperial College London; CW plusRecruiting
-
McGill UniversityCompletedFall | Aged | MusicCanada
-
Clinique Saint-VincentRecruitingLaryngeal Disease | Oropharyngeal Disease | ENT Surgery | Otologic Disease | Endonasal Surgery | Cervical Surgery | Musical Therapy | Laryngeal SurgeryReunion
-
Vanderbilt University Medical CenterCompletedPain | Critical Illness | Anxiety | RelaxationUnited States