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

Not Applicable

Recruiting

• Conditions: Psycho-Oncology
• Interventions: Other: Music therapy

• Registration Number: NCT06282887
• Lead Sponsor: Guangzhou Concord Cancer Center

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.

Study Timeline

• Study Start: 2021-11-09
• Study First Submitted: 2023-11-05
• Study First Submitted QC: 2024-02-21
• Study First Posted: 2024-02-28
• Status Verified: 2024-11
• Last Update Submitted: 2024-12-31
• Last Update Posted: 2025-01-01
• Primary Completion: 2025-11-10
• Study Completion: 2026-01-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Music Therapy Group	Music therapy	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.

Primary Outcome Measures

Name	Time	Method
Symptom distress	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	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	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 Outcome Measures

Name	Time	Method
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	The change of pulse rates during MRI scanning
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	The change of respiration rate during MRI scanning
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	Duration of actual scans require, duration of the whole process, and the frequency of pause due to patient in-compliance
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	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
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	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

Trial Locations

Locations (1)

GuangZhou Concord Cancer Center; 🇨🇳 Guangzhou, Guangdong, China