AnxietyNCT07591922
Intraoperative Music Therapy in TAVR Patients
A study testing Music in people with Anxiety, run by Rhode Island Hospital at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effect of intraoperative music on patient anxiety and comfort during transcatheter aortic valve replacement (TAVR) procedures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety
- What is being tested?
- Music
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 26 May 2026to May 2027
- 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
- Scheduled to undergo elective transfemoral TAVR under MAC (Monitored Anesthesia Care) at Rhode Island Hospital
- Able to answer questions about anxiety
Who cannot join
- Transfemoral TAVR procedures requiring general anesthesia
- Emergent TAVR procedures
- Significant hearing impairment that would preclude ability to hear music via headphones
- Documented severe claustrophobia or inability to tolerate headphones
- Inability to complete questionnaires
- Inability or unwillingness to provide informed consent
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
The Rhode Island Hospital
Providence, Rhode Island, 02903
Stephanie Farias, 1 (401) 444-4943, Stephanie.Farias@brownhealth.org
Mark Kendall, M.D., 401-444-4722, mark.kendall@brownhealth.org
About this study
Official title: Intraoperative Music Therapy in TAVR Patients: A Randomized Controlled Trial to Reduce Anxiety and Improve Patient Experience
The purpose of this study is to evaluate the effect of intraoperative music on patient anxiety and comfort during transcatheter aortic valve replacement (TAVR) procedures.
Read the detailed description
This study is exploring whether listening to music during a minimally invasive heart valve procedure called transcatheter aortic valve replacement (TAVR) can help reduce patient anxiety. TAVR is often done with light sedation, so patients may be awake and aware during parts of the procedure, which can sometimes feel stressful. In this study, patients will be randomly assigned to either listen to relaxing music through headphones during the procedure or to wear headphones without music.
- Conditions
- Anxiety
- Being tested
- Music, Control Group (no music)
- Keywords
- Anxiety, Music, Heart valve surgery, Intraoperative
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MusicBehavioural
Music will be selected from a standardized playlist and initiated by a member of the research team.
Control Group (no music)Behavioural
Headphones will be worn without audio; no music will be played.
| Study group | Role | What they receive |
|---|---|---|
| Music Group | Active comparator | Open ear headphones will be placed on the patient in the operating room and will remain in place for a minimum of 45 minutes. Headphones will be removed at the conclusion of surgery when standard monitoring is discontinued. Receives: Behavioral: Music |
| Control Group (No music) | Sham comparator | Open ear headphones will be placed on the patient in the operating room and will remain in place for a minimum of 45 minutes. Headphones will be removed at the conclusion of surgery when standard monitoring is discontinued. Receives: Behavioral: Control Group (no music) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety
Anxiety will be assessed using the State-Trait Anxiety Inventory (STAI-6), a validated 6-item questionnaire. Scores will be subsequently transformed to the full STAI-S scale (range 20-80) for reporting. Higher scores indicate greater anxiety.
Measured: Preoperative (baseline, prior to intervention), intraoperative (after valve deployment), postoperatively upon arrival to the post-anesthesia care unit (PACU) when the patient is alert and able to respond, and 24 hours after surgery.
Secondary outcomes (1)
Participant satisfaction
A questionnaire comprising multiple items to assess participants' overall intraoperative experience and satisfaction. Each item is scored on a numeric rating scale from 0 to 10, where 0 indicates "extremely dissatisfied" and 10 indicates "extremely satisfied."
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start26 May 2026
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies 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
- Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shyamal Asher, MD, Rhode Island Hospital
- Investigators
- Shyamal Asher, MD, Principal investigator, Brown University Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07591922
- Sponsor's protocol ID
- 2401855
- Status last verified
- May 2026
- First submitted
- 27 Apr 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Julian LJ. Measures of anxiety: State-Trait Anxiety Inventory (STAI), Beck Anxiety Inventory (BAI), and Hospital Anxiety and Depression Scale-Anxiety (HADS-A). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11(0 11):S467-72. doi: 10.1002/acr.20561. No abstract available.
PubMed 22588767Cruise CJ, Chung F, Yogendran S, Little D. Music increases satisfaction in elderly outpatients undergoing cataract surgery. Can J Anaesth. 1997 Jan;44(1):43-8. doi: 10.1007/BF03014323.
PubMed 8988823Bae J, Yoo S, Kim H, Kim Y, Kim JT, Lim YJ, Kim HS. Effect of real-time binaural music on sedation with dexmedetomidine during spinal anesthesia: A triple-arm, assessor-blind, randomized controlled trial. J Clin Anesth. 2023 Feb;84:110997. doi: 10.1016/j.jclinane.2022.110997. Epub 2022 Nov 10.
PubMed 36371942Ebrahimi R, Tan W. Role of Music for Conscious Sedation During Invasive Cardiac Catheterization. Am J Cardiol. 2018 Sep 15;122(6):1095-1097. doi: 10.1016/j.amjcard.2018.05.039. Epub 2018 Jun 20.
PubMed 30072130
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Music Therapy in TAVR Patients: A Randomized Controlled Trial to Reduce Anxiety and Improve Patient Experience
- ClinicalTrials.gov ID
- NCT07591922
- Acronym / sponsor ID
- 2401855
- Conditions
- Anxiety
- Keywords
- Anxiety, Music, Heart valve surgery, Intraoperative
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Study start
- 26 May 2026 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 18 May 2026 (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 purpose of this study is to evaluate the effect of intraoperative music on patient anxiety and comfort during transcatheter aortic valve replacement (TAVR) procedures.
Detailed description
This study is exploring whether listening to music during a minimally invasive heart valve procedure called transcatheter aortic valve replacement (TAVR) can help reduce patient anxiety. TAVR is often done with light sedation, so patients may be awake and aware during parts of the procedure, which can sometimes feel stressful. In this study, patients will be randomly assigned to either listen to relaxing music through headphones during the procedure or to wear headphones without music.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music Group | Active comparator | Behavioral: MusicOpen ear headphones will be placed on the patient in the operating room and will remain in place for a minimum of 45 minutes. Headphones will be removed at the conclusion of surgery when standard monitoring is discontinued. |
| Control Group (No music) | Sham comparator | Behavioral: Control Group (no music)Open ear headphones will be placed on the patient in the operating room and will remain in place for a minimum of 45 minutes. Headphones will be removed at the conclusion of surgery when standard monitoring is discontinued. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Scheduled to undergo elective transfemoral TAVR under MAC (Monitored Anesthesia Care) at Rhode Island Hospital
- Able to answer questions about anxiety
Key exclusion criteria (6 listed)
- Transfemoral TAVR procedures requiring general anesthesia
- Emergent TAVR procedures
- Significant hearing impairment that would preclude ability to hear music via headphones
- Documented severe claustrophobia or inability to tolerate headphones
- Inability to complete questionnaires
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 |
|---|---|---|
| MusicMusic will be selected from a standardized playlist and initiated by a member of the research team. | Behavioural | Music Group |
| Control Group (no music)Headphones will be worn without audio; no music will be played. | Behavioural | Control Group (No music) |
Primary outcome
Anxiety
Time frame: Preoperative (baseline, prior to intervention), intraoperative (after valve deployment), postoperatively upon arrival to the post-anesthesia care unit (PACU) when the patient is alert and able to respond, and 24 hours after surgery.
Anxiety will be assessed using the State-Trait Anxiety Inventory (STAI-6), a validated 6-item questionnaire. Scores will be subsequently transformed to the full STAI-S scale (range 20-80) for reporting. Higher scores indicate greater anxiety.
1 secondary outcome
Participant satisfaction
Time frame: 24 hours after surgery
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 20 Jul 2026.
- Background: PubMed 22588767Julian LJ. Measures of anxiety: State-Trait Anxiety Inventory (STAI), Beck Anxiety Inventory (BAI), and Hospital Anxiety and Depression Scale-Anxiety (HADS-A). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11(0 11):S467-72. doi: 10.1002/acr.20561. No abstract available.
- Background: PubMed 8988823Cruise CJ, Chung F, Yogendran S, Little D. Music increases satisfaction in elderly outpatients undergoing cataract surgery. Can J Anaesth. 1997 Jan;44(1):43-8. doi: 10.1007/BF03014323.
- Background: PubMed 36371942Bae J, Yoo S, Kim H, Kim Y, Kim JT, Lim YJ, Kim HS. Effect of real-time binaural music on sedation with dexmedetomidine during spinal anesthesia: A triple-arm, assessor-blind, randomized controlled trial. J Clin Anesth. 2023 Feb;84:110997. doi: 10.1016/j.jclinane.2022.110997. Epub 2022 Nov 10.
- Background: PubMed 30072130Ebrahimi R, Tan W. Role of Music for Conscious Sedation During Invasive Cardiac Catheterization. Am J Cardiol. 2018 Sep 15;122(6):1095-1097. doi: 10.1016/j.amjcard.2018.05.039. Epub 2018 Jun 20.
- 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.
Shyamal Asher, MD principal investigator
Brown University Health
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 in people with Anxiety, run by Rhode Island Hospital 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 2 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 20 Jul 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. Some participants in this study may receive a placebo. 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 Shyamal Asher, M.D. (401-444-5172, SAsher@brownhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety (time frame: Preoperative (baseline, prior to intervention), intraoperative (after valve deployment), postoperatively upon arrival to the post-anesthesia care unit (PACU) when the patient is alert and able to respond, and 24 hours after surgery.). 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 NCT07591922, which also lists 4 linked publications.
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 20 Jul 2026.