Psycho-Oncology
Conditions
Keywords
MRI, Anxiety, Symptom distress, Relaxation, Music therapy
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.
Interventions
OTHERMusic 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.
Sponsors
Guangzhou Concord Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Symptom distress | 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 | Self-rating scale (VAS 0-10) to rate symptom distress, with 0 being no distress and 10 being extreme distressed. |
| Relaxation | 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 | Self-rating scale (VAS 0-10) to rate relaxation, with 0 being unrelaxed and 10 being very relaxed. |
| Anxiety | 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 | Self-rating scale (VAS 0-10) to rate patient anxiety, with 0 being no anxiety and 10 being extreme anxious |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 |
| 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 | The change of pulse rates during MRI scanning |
| 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 | 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 |
| 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 | The change of respiration rate during MRI scanning |
| 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 | Duration of actual scans require, duration of the whole process, and the frequency of pause due to patient in-compliance |
Countries
China
Contacts
Primary ContactYinglan He
Outcome results
None listed