Effects of Music Therapy on Psychological States Among Cancer Patients Undergoing MRI Scans and A Relevant Mediator

February 21, 2024 updated by: Guangzhou Concord Cancer Center

The Effects of Music Therapy on Improving Psychological States of Cancer Patients Undergoing MRI Scans and A Relevant Mediator

The primary objective of this study is to examine the effects of a music therapy protocol on improving anxiety, symptom distress, and relaxation among cancer patients who are going through MRI scanning. Physiological data, such as pulse rates and respiration rates will be collected. Furthermore, data about scanning efficiency will be collected to assess if scanning efficiency is affected by the protocol implementation. The secondary study objective is to assess whether or not there is a relationship between patient attention to music during the intervention process and the changes in anxiety, symptom distress, and relaxation.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

To assess the protocol, recruited participants will be randomly allocated into two groups: a control group or a music therapy group. Participants in the control group will receive standard care as usual, and they will be offered music therapy interventions upon their request during subsequent appointments. Participants in the music group will receive standard care and music therapy interventions. All participants will rate their psychological states pre- and post-MRI exams. Their physiological data will be recorded during the examination. After the scanning, they will complete an experience review.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510700
        • Recruiting
        • GuangZhou Concord Cancer Center
        • Contact:
          • Juan Nie, Masters

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. The subject is diagnosed with cancer;
  2. The subject is between 18- 60 years old;
  3. The subject understands Mandarin, Cantonese, or English;
  4. The subject did not use medication for sedatives, anxiolytics, and/or sleep aids;
  5. The subject is awake without cognitive disorders;
  6. the subject rates more than 0 on the 0-10 VAS for anxiety;
  7. The subject has finished primary school level education.

Exclusion Criteria:

  1. The subject withdraws the MRI scan;
  2. The subject needs other intervention(s) to complete the scan;
  3. The subject has hearing and/or visual impairments;
  4. The subject has a history of a severe somatic psychiatric disease or clinically diagnosed mental disorders.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Music Therapy Group
Participants in the Music Therapy Group will receive standard care and approximately 15 minutes of music therapy before the MRI scan and will have music played through their headphones during the scanning process.
Other: Music therapy
The intervention has two parts. The first part is an approximately 15-minute music therapy session to induce relaxation and positive memories attached to the relaxing live music provided by a credentialed music therapist. The second part is music listening during the scanning process.
No Intervention: Control Group
Participants in the Control Group will receive standard care throughout the awaiting period and the scanning process.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 days
Self-rating scale (VAS 0-10) to rate patient anxiety, with 0 being no anxiety and 10 being extreme anxious
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 days
Symptom distress
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 days
Self-rating scale (VAS 0-10) to rate symptom distress, with 0 being no distress and 10 being extreme distressed.
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 days
Relaxation
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 days
Self-rating scale (VAS 0-10) to rate relaxation, with 0 being unrelaxed and 10 being very relaxed.
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pulse rates
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 day
The change of pulse rates during MRI scanning
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 day
Respiration rate
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
The change of respiration rate during MRI scanning
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Scanning efficiency
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Duration of actual scans require, duration of the whole process, and the frequency of pause due to patient in-compliance
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Patient satisfaction level
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 days
A 1 to 5 satisfaction scale, with 1 being strongly unsatisfied, 2 being unsatisfied, 3 being somewhere between unsatisfied and satisfied, 4 being quite satisfied. and 5 being strongly satisfied
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 days
Patient attention to music (only for the music therapy group)
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 days
A 1 to 5 self-rating scale, with 1 being fully attended during the whole process, 2 being attended most time during scanning, 3 being attended sometime during scanning, 4 being unattended most time during scanning, and 5 being fully unattended
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangzhou Concord Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 9, 2021

Primary Completion (Estimated)

November 10, 2024

Study Completion (Estimated)

November 10, 2024

Study Registration Dates

First Submitted

November 5, 2023

First Submitted That Met QC Criteria

February 21, 2024

First Posted (Actual)

February 28, 2024

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 21, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-IIT-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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