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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Patients 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Music | Other | Intra-procedure music through headphones |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Heart rate | To examine the effects of intra-procedure music on subjects' heart rate in interventional radiology procedures | Up to 12 months |
| Respiration rate | To examine the effects of intra-procedure music on subjects' respiration rate in interventional radiology procedures |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leora Horwitz, MD, MHS | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institutional Review Board Operations (IRB) | New York | New York | 10016 | United States |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D009147 | Music Therapy |
| ID | Term |
|---|---|
| D026421 | Sensory Art Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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| Up to 12 months |
| Blood pressure | To examine the effects of intra-procedure music on subjects' blood pressure in interventional radiology procedures | 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 | Up to 12 months |
| Pain score | To examine the effects of intra-procedure music on the subjects' pain scores during interventional radiology procedures | Up to 12 months |
| RASS score | To examine the effects of intra-proceudre music on the subjects' RASS scores during interventional radiology procedures | Up to 12 months |
| D000359 |
| Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |