Effect of Intra-procedure Music on Anxiety for Interventional Radiology Procedures
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- NYU Langone Health
- Enrollment
- 139
- Locations
- 1
- Primary Endpoint
- State-Trait Anxiety Inventory (STAI) score
Study Overview
Brief 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. 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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Single (Care Provider)
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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)
Exclusion Criteria
- •Not a moderate sedation candidate (hemodynamically unfit, not optimized for procedure, pregnant)
Arms & Interventions
Intervention
Patients in this arm will receive patient-selected music through headphones throughout their procedure.
Intervention: Music (Other)
Control
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.
Outcomes
Primary Outcomes
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)
Secondary Outcomes
- Heart rate(Up to 12 months)
- Amount of sedation required(Up to 12 months)
- Respiration rate(Up to 12 months)
- Blood pressure(Up to 12 months)
- Pain score(Up to 12 months)
- RASS score(Up to 12 months)