Effect of Intra-procedure Music on Anxiety

Not Applicable

Completed

• Conditions: Anxiety
• Interventions: Other: Music

• Registration Number: NCT03665662
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-22
• Study First Submitted QC: 2018-09-07
• Study First Posted: 2018-09-11
• Study Start: 2018-10-08
• Primary Completion: 2020-02-28
• Study Completion: 2020-02-28
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-07
• Last Update Posted: 2020-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 139

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)

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Exclusion Criteria

• Not a moderate sedation candidate (hemodynamically unfit, not optimized for procedure, pregnant)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Heart rate	Up to 12 months	To examine the effects of intra-procedure music on subjects' heart rate in 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
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
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

Trial Locations

Locations (1)

Institutional Review Board Operations (IRB); 🇺🇸 New York, New York, United States