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

NCT06282887 | Recruiting DMC

• 1 other identifier: 2021-IIT-002
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Psycho-Oncology

Keywords

MRI; Anxiety; Symptom distress; Relaxation; Music therapy

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (5)

• 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 Arms (2)

Music Therapy Group

EXPERIMENTAL

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.

Other: Music therapy

Control Group

NO INTERVENTION

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

Interventions

Music therapy 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.

Music Therapy Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangzhou Concord Cancer Center: lead

Study Sites (1)

GuangZhou Concord Cancer Center

Guangzhou, Guangdong, 510700, China

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Yinglan He

CONTACT

18320739030; wing_____5@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: All participants will be wearing a headphone, and they will not know if there will be music until they experience and finish the scan process. Radiographers are blinding to avoid biases.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2023
• First Posted: February 28, 2024
• Study Start: November 9, 2021
• Primary Completion: November 10, 2025
• Study Completion: January 10, 2026
• Last Updated: January 1, 2025

Record last verified: 2024-11

Locations

CN (1)