Advanced CancerMSPDNCT05315427
Impact of Music Therapy on Pain in Patients Treated for Advanced Cancer
A study testing one music therapy session in people with Advanced Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- one music therapy session
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteFrance
- Study dates
- 2 May 2022to 5 Jan 2023
- 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
- 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.
Who cannot join
- Patient with uncorrected hearing loss to normal
- Patient under guardianship, curatorship or safeguard of justice
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Advanced Cancer
- Being tested
- one music therapy session
- Keywords
- music therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
one music therapy sessionOther
Edmonton Symptom Assessment System (ESAS) scale (before and after music therapy session), Numerical pain scale (before and after music therapy session)
| Study group | Role | What they receive |
|---|---|---|
| Evaluation of the impact of music therapy on the pain of patients | Experimental | One music therapy session Receives: Other: one music therapy session |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: at day 1 (before and after the music therapy session)
Secondary outcomes (4)
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.
Measured: at day 1 (before and after the music therapy session)
Patient wishing a second session of music therapy
Proportion of Patient wishing a second session of music therapy
Measured: at day 1 (after the music therapy session)
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)
Measured: at day 1 (after the music therapy session)
Agreement to participate in the study
Proportion of patients agreeing to participate among the eligible patients to whom the study was proposed
Measured: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start2 May 2022
- Primary completion5 Jan 2023
- Study completion5 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- More trials run by Institut du Cancer de Montpellier - Val d'AurelleThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Caroline GALLAY, Study chair, Institut du Cancer de Montpellier - Val d'Aurelle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05315427
- Sponsor's protocol ID
- PROICM 2021-10 OMS
- Other IDs
- 2021-A02020-41
- Acronym
- MSPD
- Status last verified
- Feb 2025
- First submitted
- 17 Mar 2022
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 16722953Beck SL. The therapeutic use of music for cancer-related pain. Oncol Nurs Forum. 1991 Nov-Dec;18(8):1327-37.
PubMed 1762973Huang 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.
PubMed 20403600Krishnaswamy 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.
PubMed 27559260Alcantara-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.
PubMed 29633652Boyde 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.
PubMed 27257528Bradt 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.
PubMed 27524661Lesiuk 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.
PubMed 27517966
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Music Therapy on Pain in Patients Treated for Advanced Cancer
- ClinicalTrials.gov ID
- NCT05315427
- Acronym / sponsor ID
- MSPD / PROICM 2021-10 OMS
- Conditions
- Advanced Cancer
- Keywords
- music therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'AurelleUniversity, hospital or other
- Study start
- 2 May 2022 (actual)
- Primary completion
- 5 Jan 2023 (actual)
- Study completion
- 5 Jan 2023 (actual)
- First posted
- 7 Apr 2022 (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 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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Evaluation of the impact of music therapy on the pain of patients | Experimental | Other: one music therapy sessionOne music therapy session |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- Patient with uncorrected hearing loss to normal
- Patient under guardianship, curatorship or safeguard of justice
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 |
|---|---|---|
| one music therapy sessionEdmonton Symptom Assessment System (ESAS) scale (before and after music therapy session), Numerical pain scale (before and after music therapy session) | Other | Evaluation of the impact of music therapy on the pain of patients |
Primary outcome
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)
4 secondary outcomes
Description of symptom management
Time frame: 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)
Patient satisfaction of the music therapy session
Time frame: at day 1 (after the music therapy session)
Agreement to participate in the study
Time frame: at inclusion
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 14 Feb 2025.
- Background: PubMed 16722953Siedliecki 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.
- Background: PubMed 1762973Beck SL. The therapeutic use of music for cancer-related pain. Oncol Nurs Forum. 1991 Nov-Dec;18(8):1327-37.
- Background: PubMed 20403600Huang 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.
- Background: PubMed 27559260Krishnaswamy 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.
- Background: PubMed 29633652Alcantara-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.
- Background: PubMed 27257528Boyde 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.
- Background: PubMed 27524661Bradt 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.
- Background: PubMed 27517966Lesiuk 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.
- Individual participant dataSharing planned: No
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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.
Caroline GALLAY study chair
Institut du Cancer de Montpellier - Val d'Aurelle
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing one music therapy session in people with Advanced Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle 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 7 inclusion and 2 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 14 Feb 2025. 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?
Change between before and after music therapy session on patients pain (time frame: at day 1 (before and after the music therapy session)). 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 NCT05315427, which also lists 8 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 14 Feb 2025.