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Clinical Trials/NCT06282887
NCT06282887
Recruiting
N/A

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

Guangzhou Concord Cancer Center1 site in 1 country80 target enrollmentNovember 9, 2021
ConditionsPsycho-Oncology

Overview

Phase
N/A
Intervention
Not specified
Conditions
Psycho-Oncology
Sponsor
Guangzhou Concord Cancer Center
Enrollment
80
Locations
1
Primary Endpoint
Symptom distress
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
November 9, 2021
End Date
January 10, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Guangzhou Concord Cancer Center
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

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.

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.

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

Secondary Outcomes

  • Pulse rates(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(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(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(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)(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)

Study Sites (1)

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