Effect of Intra-procedure Music on Anxiety

NYU Langone Health139 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Enrollment

139

Conditions

Anxiety

Interventions

MusicOTHER

Intra-procedure music through headphones

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Institutional Review Board Operations (IRB)

New York, New York, United States

Outcomes

Primary Outcomes

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)

Time frame: Up to 12 months

Secondary Outcomes

Heart rate

To examine the effects of intra-procedure music on subjects' heart rate in interventional radiology procedures

Time frame: Up to 12 months

Respiration rate

To examine the effects of intra-procedure music on subjects' respiration rate in interventional radiology procedures

Time frame: Up to 12 months

Blood pressure

To examine the effects of intra-procedure music on subjects' blood pressure in interventional radiology procedures

Time frame: 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

Time frame: Up to 12 months

Pain score

To examine the effects of intra-procedure music on the subjects' pain scores during interventional radiology procedures

Time frame: Up to 12 months

RASS score

To examine the effects of intra-proceudre music on the subjects' RASS scores during interventional radiology procedures

Time frame: Up to 12 months

Data from ClinicalTrials.gov

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