NCT05315427

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 7, 2022

Completed
25 days until next milestone

Study Start

First participant enrolled

May 2, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2023

Completed
Last Updated

February 14, 2025

Status Verified

February 1, 2025

Enrollment Period

8 months

First QC Date

March 17, 2022

Last Update Submit

February 11, 2025

Conditions

Advanced Cancer

Keywords

music therapy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Description of symptom management

    at day 1 (before and after the music therapy session)

  • Patient wishing a second session of music therapy

    at day 1 (after the music therapy session)

  • Patient satisfaction of the music therapy session

    at day 1 (after the music therapy session)

  • Agreement to participate in the study

    at inclusion

Study Arms (1)

Evaluation of the impact of music therapy on the pain of patients

EXPERIMENTAL

One music therapy session

Other: one music therapy session

Interventions

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)

Evaluation of the impact of music therapy on the pain of patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patient with uncorrected hearing loss to normal
  • Patient under guardianship, curatorship or safeguard of justice

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut du Cancer de Montpellier

Montpellier, 34298, France

Location

Related Publications (8)

  • 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.

    PMID: 16722953BACKGROUND

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

    PMID: 1762973BACKGROUND

  • 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.

    PMID: 20403600BACKGROUND

  • 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.

    PMID: 27559260BACKGROUND

  • 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.

    PMID: 29633652BACKGROUND

  • 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.

    PMID: 27257528BACKGROUND

  • 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.

    PMID: 27524661BACKGROUND

  • 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.

    PMID: 27517966BACKGROUND

Study Officials

  • Caroline GALLAY

    Institut du Cancer de Montpellier - Val d'Aurelle

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2022

First Posted

April 7, 2022

Study Start

May 2, 2022

Primary Completion

January 5, 2023

Study Completion

January 5, 2023

Last Updated

February 14, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)