Effect of Intra-procedure Music on Anxiety

NYU Langone Health

Status: Completed

Conditions: Anxiety

Treatments: Other: Music

Study type: Interventional

Funder types: Other

Identifiers

NCT03665662

18-01156

Details and patient eligibility

About

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.

Enrollment: 139 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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139 participants in 2 patient groups

Intervention

Experimental group

Description:

Patients in this arm will receive patient-selected music through headphones throughout their procedure.

Treatment:

Other: Music

Control

No Intervention group

Description:

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.