Effect of Intra-procedure Music on Anxiety

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03665662
• Other study ID #: 18-01156
• Status: Completed
• Phase: N/A
• Start date: October 8, 2018
• Est. completion date: February 28, 2020

Study information

• Verified date: July 2020
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: February 28, 2020
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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)

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

Other:
• Music
Intra-procedure music through headphones

Locations

Country	Name	City	State
United States	Institutional Review Board Operations (IRB)	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Heart rate	To examine the effects of intra-procedure music on subjects' heart rate in interventional radiology procedures	Up to 12 months
Secondary	Respiration rate	To examine the effects of intra-procedure music on subjects' respiration rate in interventional radiology procedures	Up to 12 months
Secondary	Blood pressure	To examine the effects of intra-procedure music on subjects' blood pressure in interventional radiology procedures	Up to 12 months
Secondary	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
Secondary	Pain score	To examine the effects of intra-procedure music on the subjects' pain scores during interventional radiology procedures	Up to 12 months
Secondary	RASS score	To examine the effects of intra-proceudre music on the subjects' RASS scores during interventional radiology procedures	Up to 12 months