Music Intervention on Palliative Patients

NCT03758703 | Unknown

• 1 other identifier: 5316
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 2

Brief Summary

Palliative/hospice care patients experience many negative symptoms during their time in such facilities. These symptoms include, but are usually not limited to, pain, anxiety, depression, and so on. This study is interested in exploring how a music intervention can be used to reduce these symptoms in order to improve the quality of life for these patients. Specifically, because music interventions can be costly (e.g., employing music therapists and the likes of) and there is a lack of knowledge about how to properly implement music interventions, we believe that it would be most cost-effective as well as effective in reducing the described symptoms by introducing pre-recorded music as an intervention. Patients will be given pre-recorded music which requires less training and less money but may be just as effective as music interventions that do not use pre-recorded music. Patients will be evaluated by administering surveys at predetermined times to measure their symptoms, and interview-like questions will be administered at the end of the study to collect information that will be used to inform a larger study in the future. This study will, therefore, be collecting data on both how effective the intervention is and how feasible it is to use the same methods for a similar larger study in the future.

Conditions

Palliative Care

Outcome Measures

Primary Outcomes (3)

• Assessing changes in quality of life in palliative care patients

  Self-report Hospice Quality of Life Index-Revised (HQLI-R) questionnaire with 29 items; each question ranges from 0 to 10 (0 indicating the lowest quality and 10 indicating the highest quality). This yields a total score between 0 and 290.

  3 days (days 1,3 and 7 of data collection)

• Assessing changes in symptom severity in palliative care patients

  Self-report Edmonton Symptom Assessment Scale-revised (ESAS-R) questionnaire with 10 items; each item ranges from 0 to 10 (0 indicating low to no severity in symptoms or that the symptom is absent, and 10 indicating the highest symptom severity). This yields a total score between 0 and 100.

  7 days (days 1 through 7 of data collection)

• Assessing changes in trait and state anxiety in palliative care patients

  Self-report State-Trait Anxiety Inventory Scale (STAI-S) questionnaire with 20 items; each item ranges from 1 to 4 (1 indicating low to no anxiety and 4 indicating the highest anxiety). This yields a total score between 0 and 80.

  7 days (days 1 through 7 of data collection)

Secondary Outcomes (1)

• Assessing trial feasibility for a larger future RCT

  1 day (day 7 of data collection)

Study Arms (2)

Pre-recorded music intervention group

EXPERIMENTAL

The experimental group will be receiving the pre-recorded music care intervention. The intervention is to be delivered once a day for 30 minutes, over one week, on a portable Bluetooth speaker system. Participants will select their own music from the list of pre-recorded songs playlist and are free to switch to another playlist within their treatment arm should they desire. This music was specifically designed for use in palliative care. Specifically, all songs are played at 60 beats per minute to mimic resting heart rate. Instrumentation was specifically chosen to be soothing and calming

Other: Pre-recorded music intervention group

Pre-recorded soothing poetry group

ACTIVE COMPARATOR

The control group will be provided pre-recorded soothing poetry which they will self-select. Participants are allowed to switch playlists within their treatment arm each day should they desire. This control group is designed to control time, attention, and placebo effect. Thus, the soothing poetry will be offered the identical time duration of listening to recorded soothing poetry readings and played at the same time the intervention group receives the pre-recorded music.

Other: Pre-recorded soothing poetry group

Interventions

Pre-recorded music intervention group OTHER

Refer to the arm/group descriptions.

Pre-recorded music intervention group

Pre-recorded soothing poetry group OTHER

Refer to the arm/group descriptions.

Pre-recorded soothing poetry group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• English-speaking;
• A score of 3 or higher on ESAS scale for pain and anxiety
• Cognitively alert and competent to provide informed consent
• A Palliative Performance Scale of at least 40/100.

You may not qualify if:

• Participants with a prognosis of fewer than 2 weeks or an expectation of leaving the inpatient setting within a 2 week period.

Sponsors & Collaborators

• McMaster University: lead

Study Sites (2)

Emmanuel House Good Shepherd Residential Hospice

Hamilton, Ontario, L8R 2X5, Canada

Location

Dr Bob Kemp Hospice

Hamilton, Ontario, L9B 1B1, Canada

Location

Related Publications (12)

• Institute of Medicine (US) Committee on Care at the End of Life; Field MJ, Cassel CK, editors. Approaching Death: Improving Care at the End of Life. Washington (DC): National Academies Press (US); 1997. Available from http://www.ncbi.nlm.nih.gov/books/NBK233605/

  PMID: 25121204 BACKGROUND

• Morrison RS, Meier DE. Clinical practice. Palliative care. N Engl J Med. 2004 Jun 17;350(25):2582-90. doi: 10.1056/NEJMcp035232. No abstract available.

  PMID: 15201415 BACKGROUND

• O'Callaghan CC. Pain, music creativity and music therapy in palliative care. Am J Hosp Palliat Care. 1996 Mar-Apr;13(2):43-9. doi: 10.1177/104990919601300211.

  PMID: 8716327 BACKGROUND

• Archie P, Bruera E, Cohen L. Music-based interventions in palliative cancer care: a review of quantitative studies and neurobiological literature. Support Care Cancer. 2013 Sep;21(9):2609-24. doi: 10.1007/s00520-013-1841-4. Epub 2013 May 30.

  PMID: 23715815 BACKGROUND

• Clements-Cortes A. The use of music in facilitating emotional expression in the terminally ill. Am J Hosp Palliat Care. 2004 Jul-Aug;21(4):255-60. doi: 10.1177/104990910402100406.

  PMID: 15315187 BACKGROUND

• Olofsson A, Fossum B. Perspectives on music therapy in adult cancer care: a hermeneutic study. Oncol Nurs Forum. 2009 Jul;36(4):E223-31. doi: 10.1188/09.ONF.E223-E231.

  PMID: 19581226 BACKGROUND

• 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: 27524661 BACKGROUND

• McMillan SC, Weitzner M. Quality of life in cancer patients: use of a revised Hospice Index. Cancer Pract. 1998 Sep-Oct;6(5):282-8. doi: 10.1046/j.1523-5394.1998.00023.x.

  PMID: 9767348 BACKGROUND

• Bruera E, Kuehn N, Miller MJ, Selmser P, Macmillan K. The Edmonton Symptom Assessment System (ESAS): a simple method for the assessment of palliative care patients. J Palliat Care. 1991 Summer;7(2):6-9.

  PMID: 1714502 BACKGROUND

• Spielberger CD, Gorsuch RL, Lushene R, Vagg PR, Jacobs GA. Manual for the state-trait anxiety inventory (Palo Alto, CA, Consulting Psychologists Press). Inc. 1983.

  BACKGROUND

• Thabane L, Ma J, Chu R, Cheng J, Ismaila A, Rios LP, Robson R, Thabane M, Giangregorio L, Goldsmith CH. A tutorial on pilot studies: the what, why and how. BMC Med Res Methodol. 2010 Jan 6;10:1. doi: 10.1186/1471-2288-10-1.

  PMID: 20053272 BACKGROUND

• Abbott JH. The distinction between randomized clinical trials (RCTs) and preliminary feasibility and pilot studies: what they are and are not. J Orthop Sports Phys Ther. 2014 Aug;44(8):555-8. doi: 10.2519/jospt.2014.0110. No abstract available.

  PMID: 25082389 BACKGROUND

Related Links

• The State of Seniors Health Care in Canada
• What Canadians Say: The Way Forward Survey Report
• Episodes of Relationship Completion Through Song in Palliative Care

Study Officials

• Chelsea Mackinnon, MA, MMIE

  McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arbaaz A Patel

CONTACT

9055368221; patela11@mcmaster.ca

Caleb Kim

CONTACT

2898778197; kimc1@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Because of the nature of the intervention, it is not possible to perform blinding/masking.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Bachelor of Health Sciences Student at McMaster University

Model Details: This study will employ a pragmatic parallel randomized-control trial design as a mixed-methods study in which approximately half of the participants will be randomized into a control and the other remaining half in the experimental group.

Study Record Dates

• First Submitted: November 23, 2018
• First Posted: November 29, 2018
• Study Start: December 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: May 1, 2020
• Last Updated: October 8, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)