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Recruiting NCT06282887

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

No phase Interventional Psycho-Oncology

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Music therapy.
Who it may be relevant to
Registry conditions: Psycho-Oncology. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • 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]
  • 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]
  • 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]
Secondary outcome measures (5)
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Supportive care

Study locations

China · 1 center
  • GuangZhou Concord Cancer Center — Guangzhou

Identifiers

NCT: NCT06282887 · 2021-IIT-002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗