Clinical trial NCT06282887: Effects of Music Therapy on Psychological States Among Cancer Patients Undergoing MRI Scans and a Relevant Mediator
Official title: The Effects of Music Therapy on Improving Psychological States of Cancer Patients Undergoing MRI Scans and a Relevant Mediator
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Psycho-Oncology
Keywords: MRI
Anxiety
Symptom distress
Relaxation
Music therapy
Lead sponsor: Guangzhou Concord Cancer Center
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Anxiety
timeFrame: 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
measure: Symptom distress
timeFrame: 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
measure: Relaxation
timeFrame: 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:
measure: Pulse rates
timeFrame: 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
measure: Respiration rate
timeFrame: 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
measure: Scanning efficiency
timeFrame: 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
measure: Patient satisfaction level
timeFrame: 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
measure: Patient attention to music (only for the music therapy group)
timeFrame: 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
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: GuangZhou Concord Cancer Center
state: Guangdong
Study officials:
References: