Effect of Intra-procedure Music on Anxiety

Effect of Intra-procedure Music on Anxiety for Interventional Radiology Procedures

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 Overview

• Status: Completed
• Conditions: Anxiety
• Intervention / Treatment: Other: Music

• Study Type: Interventional
• Enrollment (Actual): 139
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • Institutional Review Board Operations (IRB)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Patients in this arm will receive patient-selected music through headphones throughout their procedure.	Other: Music; Intra-procedure music through headphones
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2018
• Primary Completion (Actual): February 28, 2020
• Study Completion (Actual): February 28, 2020

Study Registration Dates

• First Submitted: August 22, 2018
• First Submitted That Met QC Criteria: September 7, 2018
• First Posted (Actual): September 11, 2018

Study Record Updates

• Last Update Posted (Actual): July 9, 2020
• Last Update Submitted That Met QC Criteria: July 7, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 18-01156

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No