Anxiety
Conditions
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.
Interventions
OTHERMusic
Intra-procedure music through headphones
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| State-Trait Anxiety Inventory (STAI) score | 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
| Measure | Time frame | Description |
|---|---|---|
| Respiration rate | Up to 12 months | To examine the effects of intra-procedure music on subjects' respiration rate in interventional radiology procedures |
| Blood pressure | Up to 12 months | To examine the effects of intra-procedure music on subjects' blood pressure in interventional radiology procedures |
| Heart rate | Up to 12 months | To examine the effects of intra-procedure music on subjects' heart rate in interventional radiology procedures |
| Pain score | Up to 12 months | To examine the effects of intra-procedure music on the subjects' pain scores during interventional radiology procedures |
| RASS score | Up to 12 months | To examine the effects of intra-proceudre music on the subjects' RASS scores during interventional radiology procedures |
| Amount of sedation required | Up to 12 months | To examine the effects of intra-procedure music on the amount of sedation required for subjects in interventional radiology procedures |
Countries
United States
Outcome results
None listed