AnxietyNCT03665662
Effect of Intra-procedure Music on Anxiety
A study testing Music in people with Anxiety, run by NYU Langone Health at 1 site in United States.
Trial summary
The purpose of this study is to examine the effects of intra-procedure music intervention on procedural anxiety, physiological stress and sedation requirements in patients undergoing moderate sedation procedures. Study participants will be randomly assigned into two groups: 1. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- Music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Oct 2018to 28 Feb 2020
- 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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult (>18 years old) patients
- Scheduled for moderate sedation procedures in the Interventional Radiology department at Tisch Hospital, NYU Langone Health in New York, New York
- Able to read and write in English at a sixth grade level (STAI is written at sixth grade comprehension level)
Who cannot join
- Not a moderate sedation candidate (hemodynamically unfit, not optimized for procedure, pregnant)
Trial locations and contacts
1 site in 1 country.
United States1 site
Institutional Review Board Operations (IRB)
New York, New York, 10016
About this study
Official title: Effect of Intra-procedure Music on Anxiety for Interventional Radiology Procedures
The purpose of this study is to examine the effects of intra-procedure music intervention on procedural anxiety, physiological stress and sedation requirements in patients undergoing moderate sedation procedures. Study participants will be randomly assigned into two groups: 1. Control - standard care without music intervention. 2. Intervention - standard of care plus music intervention. The State-Trait Anxiety Inventory questionnaire will be provided pre, intra and post procedure to all subjects in addition to an exit survey.
- Conditions
- Anxiety
- Being tested
- Music
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MusicOther
Intra-procedure music through headphones
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Patients in this arm will receive patient-selected music through headphones throughout their procedure. Receives: Other: Music |
| Control | No intervention | Patients will be wearing headphones during their procedure (for the purpose of blinding the care team), but will not receive any music, sounds or sound-cancelling effects through the headphones. |
What is being measured
The primary outcome is the main question the study is designed to answer.
State-Trait Anxiety Inventory (STAI) score
To examine the effects of intra-procedure music on subjects' anxiety surrounding (pre, during, post) procedures in interventional radiology. Anxiety will be measured by a validated questionnaire called the State-Trait Anxiety Inventory (STAI)
Measured: Up to 12 months
Secondary outcomes (6)
Heart rate
To examine the effects of intra-procedure music on subjects' heart rate in interventional radiology procedures
Measured: Up to 12 months
Respiration rate
To examine the effects of intra-procedure music on subjects' respiration rate in interventional radiology procedures
Measured: Up to 12 months
Blood pressure
To examine the effects of intra-procedure music on subjects' blood pressure in interventional radiology procedures
Measured: Up to 12 months
Amount of sedation required
To examine the effects of intra-procedure music on the amount of sedation required for subjects in interventional radiology procedures
Measured: Up to 12 months
Pain score
To examine the effects of intra-procedure music on the subjects' pain scores during interventional radiology procedures
Measured: Up to 12 months
RASS score
To examine the effects of intra-proceudre music on the subjects' RASS scores during interventional radiology procedures
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2018
- Study start8 Oct 2018
- Primary completion28 Feb 2020
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leora Horwitz, MD, MHS, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03665662
- Sponsor's protocol ID
- 18-01156
- Status last verified
- Jul 2020
- First submitted
- 22 Aug 2018
- Last updated
- 9 Jul 2020
- 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 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intra-procedure Music on Anxiety for Interventional Radiology Procedures
- ClinicalTrials.gov ID
- NCT03665662
- Acronym / sponsor ID
- 18-01156
- Conditions
- Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 8 Oct 2018 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 11 Sep 2018 (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 examine the effects of intra-procedure music intervention on procedural anxiety, physiological stress and sedation requirements in patients undergoing moderate sedation procedures. Study participants will be randomly assigned into two groups: 1. Control - standard care without music intervention. 2. Intervention - standard of care plus music intervention. The State-Trait Anxiety Inventory questionnaire will be provided pre, intra and post procedure to all subjects in addition to an exit survey.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: MusicPatients in this arm will receive patient-selected music through headphones throughout their procedure. |
| Control | No intervention | –Patients will be wearing headphones during their procedure (for the purpose of blinding the care team), but will not receive any music, sounds or sound-cancelling effects through the headphones. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult (>18 years old) patients
- Scheduled for moderate sedation procedures in the Interventional Radiology department at Tisch Hospital, NYU Langone Health in New York, New York
- Able to read and write in English at a sixth grade level (STAI is written at sixth grade comprehension level)
Key exclusion criteria (1 listed)
- Not a moderate sedation candidate (hemodynamically unfit, not optimized for procedure, pregnant)
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 |
|---|---|---|
| MusicIntra-procedure music through headphones | Other | Intervention |
Primary outcome
State-Trait Anxiety Inventory (STAI) score
Time frame: Up to 12 months
To examine the effects of intra-procedure music on subjects' anxiety surrounding (pre, during, post) procedures in interventional radiology. Anxiety will be measured by a validated questionnaire called the State-Trait Anxiety Inventory (STAI)
6 secondary outcomes
Heart rate
Time frame: Up to 12 months
Respiration rate
Time frame: Up to 12 months
Blood pressure
Time frame: Up to 12 months
Amount of sedation required
Time frame: Up to 12 months
Pain score
Time frame: Up to 12 months
RASS score
Time frame: Up to 12 months
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 Jul 2020.
- 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.
Leora Horwitz, MD, MHS principal investigator
NYU Langone 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 NYU Langone Health 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 3 inclusion and 1 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 Jul 2020. 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?
State-Trait Anxiety Inventory (STAI) score (time frame: Up to 12 months). 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 Jul 2020.