StressNCT06536504
A Randomized Controlled Trial to Assess the Impact of Live and Recorded Music-Based Interventions on Pre-operative Stress, Mood, Pain and Biomarkers, in Neurosurgical Patients (Music-STAR Trial)
A study testing Steinway Spirio M recording/player piano in people with Stress and Pain, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The study plans to enroll a total of 132 patients. The goal of this study is to measure pre-and post-music intervention changes in patients' vital signs, serum- and plasma-level biomarkers by broad-spectrum proteomics analysis, metabolic analysis, and perceived pain, anxiety, and mood states as measured by validated… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Steinway Spirio M recording/player piano
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Dec 2024to 1 Mar 2029
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) Patients undergoing neurosurgical procedures will be eligible to enroll in this study.
Who cannot join
- Patient is unable or unwilling to provide informed consent.
- Patient is deaf or hearing-disabled.
- Patient is less than 18 years in age.
- Patient was previously enrolled in the study.
- Non-English-speaking patients (patient must be fluent in English and not require translation services per MDACC institutional policy.
- Subjects on contact isolation precautions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Mei Rui, DMA, 713-745-4243, mrui@mdanderson.org
About this study
The study plans to enroll a total of 132 patients. The goal of this study is to measure pre-and post-music intervention changes in patients' vital signs, serum- and plasma-level biomarkers by broad-spectrum proteomics analysis, metabolic analysis, and perceived pain, anxiety, and mood states as measured by validated questionnaires (STAI-S, POMS-SF, and VASP). We will collect demographic information on each participant. Participants will also complete the Brief Musical Experience Questionnaire (BMEQ) to investigate potential links between susceptibility to music-induced anxiolysis and prior musical training, preference and exposure.
Read the detailed description
Primary Objectives:
- To evaluate the effects of the two (live and recorded) prescribed preoperative containing CER on physiologic and perceived stress in patients undergoing Neurosurgery.
- To evaluate the effects of those two music interventions on serum- and plasma-level stress biomarkers and cytokines in those patients.
Secondary Objectives:
- To measure correlative effects of demographic variables, prior musical training, experience, preference, and exposure to music.
- Being tested
- Steinway Spirio M recording/player piano
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Steinway Spirio M recording/player pianoOther
Patients will be equally randomized into one of the three arms (simulated live music, recorded music, or no music) applying the random permutated block. Randomization will be conducted via an approved institutional database with the randomization list generated by the study statistician.
| Study group | Role | What they receive |
|---|---|---|
| Patients: Simulated Live Music | Experimental | Patients will be screened for eligibility, enrolled in the study and randomized 1:1:1. Receives: Other: Steinway Spirio M recording/player piano |
| Patients: Recorded Music | Experimental | Patients will be screened for eligibility, enrolled in the study and randomized 1:1:1. Receives: Other: Steinway Spirio M recording/player piano |
| Patients: Control: No Music | Experimental | Patients will be screened for eligibility, enrolled in the study and randomized 1:1:1. Receives: Other: Steinway Spirio M recording/player piano |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stress and mood changes
Pre-post intervention changes in physiologic and perceived stress and mood changes by BP, STAI-S, VASP and POM-S.
Measured: Through study cmpletion
Stress biomarkers
Proteomic and metabolomic analyses, in stress biomarkers and cytokines including IL-6, cortisol and epinephrine.
Measured: Through study completion
Secondary outcomes (1)
BMEQ (Brief Music Experience Questionnaire)
Approximately 15 minutes to complete each time)
Measured: Through study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start19 Dec 2024
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mei Rui, DMA, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06536504
- Sponsor's protocol ID
- 2024-0082
- Other IDs
- NCI-2024-06549
- Status last verified
- Jun 2026
- First submitted
- 31 Jul 2024
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Anyanwu A, Suki D, Huynh A, Draetta G, Noll K, Lee JJ, Lang FF, Rui M. Music-STAR trial: study protocol for a randomised controlled trial to assess the impact of live and recorded music-based interventions on preoperative stress, mood, pain and biomarkers in neurosurgical patients. BMJ Open. 2026 Oct 5;16(10):e110925. doi: 10.1136/bmjopen-2025-110925.
PubMed 42833720
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Assess the Impact of Live and Recorded Music-Based Interventions on Pre-operative Stress, Mood, Pain and Biomarkers, in Neurosurgical Patients (Music-STAR Trial)
- ClinicalTrials.gov ID
- NCT06536504
- Acronym / sponsor ID
- 2024-0082
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 19 Dec 2024 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2029 (estimated)
- First posted
- 5 Aug 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 study plans to enroll a total of 132 patients. The goal of this study is to measure pre-and post-music intervention changes in patients' vital signs, serum- and plasma-level biomarkers by broad-spectrum proteomics analysis, metabolic analysis, and perceived pain, anxiety, and mood states as measured by validated questionnaires (STAI-S, POMS-SF, and VASP). We will collect demographic information on each participant. Participants will also complete the Brief Musical Experience Questionnaire (BMEQ) to investigate potential links between susceptibility to music-induced anxiolysis and prior musical training, preference and exposure.
Detailed description
Primary Objectives:
- To evaluate the effects of the two (live and recorded) prescribed preoperative containing CER on physiologic and perceived stress in patients undergoing Neurosurgery.
- To evaluate the effects of those two music interventions on serum- and plasma-level stress biomarkers and cytokines in those patients.
Secondary Objectives:
- To measure correlative effects of demographic variables, prior musical training, experience, preference, and exposure to music.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients: Simulated Live Music | Experimental | Other: Steinway Spirio M recording/player pianoPatients will be screened for eligibility, enrolled in the study and randomized 1:1:1. |
| Patients: Recorded Music | Experimental | Other: Steinway Spirio M recording/player pianoPatients will be screened for eligibility, enrolled in the study and randomized 1:1:1. |
| Patients: Control: No Music | Experimental | Other: Steinway Spirio M recording/player pianoPatients will be screened for eligibility, enrolled in the study and randomized 1:1:1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1) Patients undergoing neurosurgical procedures will be eligible to enroll in this study.
Key exclusion criteria (6 listed)
- Patient is unable or unwilling to provide informed consent.
- Patient is deaf or hearing-disabled.
- Patient is less than 18 years in age.
- Patient was previously enrolled in the study.
- Non-English-speaking patients (patient must be fluent in English and not require translation services per MDACC institutional policy.
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 |
|---|---|---|
| Steinway Spirio M recording/player pianoPatients will be equally randomized into one of the three arms (simulated live music, recorded music, or no music) applying the random permutated block. Randomization will be conducted via an approved institutional database with the randomization list generated by the study statistician. | Other | Patients: Control: No Music, Patients: Recorded Music, Patients: Simulated Live Music |
Primary outcome
Stress and mood changes
Time frame: Through study cmpletion
Pre-post intervention changes in physiologic and perceived stress and mood changes by BP, STAI-S, VASP and POM-S.
Stress biomarkers
Time frame: Through study completion
Proteomic and metabolomic analyses, in stress biomarkers and cytokines including IL-6, cortisol and epinephrine.
1 secondary outcome
BMEQ (Brief Music Experience Questionnaire)
Time frame: Through study completion
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 12 Jun 2026.
- Derived from this study: PubMed 42833720Anyanwu A, Suki D, Huynh A, Draetta G, Noll K, Lee JJ, Lang FF, Rui M. Music-STAR trial: study protocol for a randomised controlled trial to assess the impact of live and recorded music-based interventions on preoperative stress, mood, pain and biomarkers in neurosurgical patients. BMJ Open. 2026 Oct 5;16(10):e110925. doi: 10.1136/bmjopen-2025-110925.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Mei Rui, DMA principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Steinway Spirio M recording/player piano in people with Stress and Pain, run by M.D. Anderson Cancer Center at 1 site in United States.
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 1 inclusion and 6 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 12 Jun 2026. 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 United States. 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 Mei Rui, DMA (7137454243, mrui@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stress and mood changes (time frame: Through study cmpletion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06536504, which also lists 1 linked publication.
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 12 Jun 2026.