Opioid UseNCT05098561
Music Therapy for Post-cardiac Surgery Pain Management
A study testing Music Treatment in people with Opioid Use, run by Steward St. Elizabeth's Medical Center of Boston, Inc. at 1 site in United States.
Trial summary
Music therapy as a supplement to post surgery pain management in cardiac surgery patients following median sternotomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use
- What is being tested?
- Music Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2018to 15 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Patients undergoing cardiac surgery via median sternotomy
Who cannot join
- Emergency cases.
- Patients with hearing impairment.
- Patients with dementia or other mental status changes.
- Patients who are clinically unstable postoperatively.
- Patients who develop postoperative complications.
- Patients who are non-English speaking.
Trial locations and contacts
1 site in 1 country.
United States1 site
Steward St. Elizabeth medical Center
Brighton, Massachusetts, 02135
About this study
Official title: Music Therapy as a Supplement to Post Surgery Pain Management in Cardiac Surgery Patient Following Median Sternotomy
Music therapy as a supplement to post surgery pain management in cardiac surgery patients following median sternotomy.
Read the detailed description
- Specific Aims:
- Primary Aim: To assess whether music therapy can decrease the amount of opioid type pain medications used. Hypothesis: Music therapy reduces the amount of opioid type pain medication used in management of post-operative pain and discomfort.
- Secondary Aims:
- To identify the gender and age groups of patients who can benefit from music therapy as a supplement to post-operative pain management.
Hypothesis: Majority of the population of patient benefits from music therapy as a supplement to postoperative pain management.
ii. To assess whether music therapy can increase patient satisfaction.
Hypothesis: Music therapy increases patient satisfaction.
- Conditions
- Opioid Use
- Being tested
- Music Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music TreatmentOther
The nurse will set up the appropriate music genre for the each music treatment patient, based on patient's preference obtained from the pre-operative questionnaire, by using the bedside computer and using Pandora, the internet music streaming service.
| Study group | Role | What they receive |
|---|---|---|
| Music treatment group | Experimental | The nurse will set up the appropriate music genre for the each music treatment patient, based on patient's preference obtained from the pre-operative questionnaire, by using the bedside computer and using Pandora, the internet music streaming service. Receives: Other: Music Treatment |
| Control Group | No intervention | No music treatment will be used. Standard pain and comfort measure only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The amount of Opioid type pain medication used
To assess whether the use of music therapy can decrease the amount of opioid type pain medications used.
Measured: In the immediate post operative period, while patient still in the ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2021
- Study start15 Oct 2018
- Primary completion15 Sep 2024
- Study completion15 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid UseStudies 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
- Single group
- Model description
- Randomize patients into music treatment group and non-music treatment control group. 30 patients per group. Patients will be enrolled into each group on an alternate bases.
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Steward St. Elizabeth's Medical Center of Boston, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stanley Tam, Principal investigator, Steward St Elizabeth Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05098561
- Sponsor's protocol ID
- 00770
- Status last verified
- Mar 2026
- First submitted
- 18 Sep 2021
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Music Therapy as a Supplement to Post Surgery Pain Management in Cardiac Surgery Patient Following Median Sternotomy
- ClinicalTrials.gov ID
- NCT05098561
- Acronym / sponsor ID
- 00770
- Conditions
- Opioid Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Steward St. Elizabeth's Medical Center of Boston, Inc.University, hospital or other
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 15 Sep 2024 (actual)
- Study completion
- 15 Sep 2024 (actual)
- First posted
- 28 Oct 2021 (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.
Music therapy as a supplement to post surgery pain management in cardiac surgery patients following median sternotomy.
Detailed description
- Specific Aims:
- Primary Aim: To assess whether music therapy can decrease the amount of opioid type pain medications used. Hypothesis: Music therapy reduces the amount of opioid type pain medication used in management of post-operative pain and discomfort.
- Secondary Aims:
- To identify the gender and age groups of patients who can benefit from music therapy as a supplement to post-operative pain management.
Hypothesis: Majority of the population of patient benefits from music therapy as a supplement to postoperative pain management.
ii. To assess whether music therapy can increase patient satisfaction.
Hypothesis: Music therapy increases patient satisfaction.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomize patients into music treatment group and non-music treatment control group. 30 patients per group. Patients will be enrolled into each group on an alternate bases.
| Arm | Type | Receives |
|---|---|---|
| Music treatment group | Experimental | Other: Music TreatmentThe nurse will set up the appropriate music genre for the each music treatment patient, based on patient's preference obtained from the pre-operative questionnaire, by using the bedside computer and using Pandora, the internet music streaming service. |
| Control Group | No intervention | –No music treatment will be used. Standard pain and comfort measure only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing cardiac surgery via median sternotomy
Key exclusion criteria (6 listed)
- Emergency cases.
- Patients with hearing impairment.
- Patients with dementia or other mental status changes.
- Patients who are clinically unstable postoperatively.
- Patients who develop postoperative complications.
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 TreatmentThe nurse will set up the appropriate music genre for the each music treatment patient, based on patient's preference obtained from the pre-operative questionnaire, by using the bedside computer and using Pandora, the internet music streaming service. | Other | Music treatment group |
Primary outcome
The amount of Opioid type pain medication used
Time frame: In the immediate post operative period, while patient still in the ICU
To assess whether the use of music therapy can decrease the amount of opioid type pain medications used.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Stanley Tam principal investigator
Steward St Elizabeth Medical 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 Music Treatment in people with Opioid Use, run by Steward St. Elizabeth's Medical Center of Boston, Inc. 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: finished, as of the sponsor's last update on 9 Mar 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The amount of Opioid type pain medication used (time frame: In the immediate post operative period, while patient still in the ICU). 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 9 Mar 2026.