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Trial Title:
Effects of Music Therapy on Psychological States Among Cancer Patients Undergoing MRI Scans and A Relevant Mediator
NCT ID:
NCT06282887
Condition:
Psycho-Oncology
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
MRI
Anxiety
Symptom distress
Relaxation
Music therapy
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Double (Participant, Care Provider)
Masking description:
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.
Intervention:
Intervention type:
Other
Intervention name:
Music therapy
Description:
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.
Arm group label:
Music Therapy Group
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
60 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
GuangZhou Concord Cancer Center
Address:
City:
Guangzhou
Zip:
510700
Country:
China
Status:
Recruiting
Contact:
Last name:
Juan Nie, Masters
Start date:
November 9, 2021
Completion date:
November 10, 2024
Lead sponsor:
Agency:
Guangzhou Concord Cancer Center
Agency class:
Other
Source:
Guangzhou Concord Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06282887
