Psycho-OncologyNCT06282887
Effects of Music Therapy on Psychological States Among Cancer Patients Undergoing MRI Scans and a Relevant Mediator
A study testing Music therapy in people with Psycho-Oncology, run by Guangzhou Concord Cancer Center at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Psycho-Oncology
- What is being tested?
- Music therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 9 Nov 2021to 10 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
GuangZhou Concord Cancer Center
Guangzhou, Guangdong, 510700
Juan Nie, Masters
About this study
Official title: The Effects of Music Therapy on Improving Psychological States of Cancer Patients Undergoing MRI Scans and a Relevant Mediator
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.
Read the 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
- Being tested
- Music therapy
- Keywords
- MRI, Anxiety, Symptom distress, Relaxation, Music therapy
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Music therapy |
| Control Group | No intervention | Participants in the Control Group will receive standard care throughout the awaiting period and the scanning process. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety
Self-rating scale (VAS 0-10) to rate patient anxiety, with 0 being no anxiety and 10 being extreme anxious
Measured: 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.
Measured: 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.
Measured: 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
The change of pulse rates during MRI scanning
Measured: 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
The change of respiration rate during MRI scanning
Measured: 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
Duration of actual scans require, duration of the whole process, and the frequency of pause due to patient in-compliance
Measured: 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
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
Measured: 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)
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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start9 Nov 2021
- Primary completion10 Nov 2025 (estimated)
- Study completion10 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psycho-OncologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Concord Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06282887
- Sponsor's protocol ID
- 2021-IIT-002
- Status last verified
- Nov 2024
- First submitted
- 5 Nov 2023
- Last updated
- 1 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Music Therapy on Improving Psychological States of Cancer Patients Undergoing MRI Scans and a Relevant Mediator
- ClinicalTrials.gov ID
- NCT06282887
- Acronym / sponsor ID
- 2021-IIT-002
- Conditions
- Psycho-Oncology
- Keywords
- MRI, Anxiety, Symptom distress, Relaxation, Music therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Guangzhou Concord Cancer CenterUniversity, hospital or other
- Study start
- 9 Nov 2021 (actual)
- Primary completion
- 10 Nov 2025 (estimated)
- Study completion
- 10 Jan 2026 (estimated)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music Therapy Group | Experimental | Other: Music therapyParticipants 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. |
| Control Group | No intervention | –Participants in the Control Group will receive standard care throughout the awaiting period and the scanning process. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music therapyThe 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. | Other | Music Therapy Group |
Primary outcome
Anxiety
Time frame: 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
Symptom distress
Time frame: 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
Time frame: 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.
5 secondary outcomes
Pulse rates
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music therapy in people with Psycho-Oncology, run by Guangzhou Concord Cancer Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yinglan He (18320739030, wing_____5@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety (time frame: 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jan 2025.