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

Psycho-Oncology Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06282887
• Other study ID #: 2021-IIT-002
• Status: Recruiting
• Phase: N/A
• Start date: November 9, 2021
• Est. completion date: November 10, 2024

Study information

• Verified date: February 2024
• Source: Guangzhou Concord Cancer Center
• Contact: Yinglan He
• Phone: 18320739030
• Email: wing_____5[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: November 10, 2024
• Est. primary completion date: November 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasms
• Psycho-Oncology

Intervention

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.

Locations

Country	Name	City	State
China	GuangZhou Concord Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou Concord Cancer Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety	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
Primary	Symptom distress	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
Primary	Relaxation	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	Pulse rates	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
Secondary	Respiration rate	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
Secondary	Scanning efficiency	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
Secondary	Patient satisfaction level	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
Secondary	Patient attention to music (only for the music therapy group)	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