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

NCT ID: NCT06282887

Last Updated: 2025-01-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-09
• Study Completion Date: 2026-01-10

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.

Conditions

Psycho-Oncology

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Music therapy

Intervention Type: OTHER

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.

Control Group

Participants in the Control Group will receive standard care throughout the awaiting period and the scanning process.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangzhou Concord Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

GuangZhou Concord Cancer Center

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yinglan He

Role: CONTACT

wing_____5@hotmail.com

18320739030

Facility Contacts

Juan Nie, Masters

Role: primary

Other Identifiers

2021-IIT-002

Identifier Type: -

Identifier Source: org_study_id