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Effect of Intra-procedure Music on Anxiety

Primary Purpose

Anxiety

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Music
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Anxiety

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts 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)

Sites / Locations

  • Institutional Review Board Operations (IRB)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Heart rate
To examine the effects of intra-procedure music on subjects' heart rate in interventional radiology procedures
Respiration rate
To examine the effects of intra-procedure music on subjects' respiration rate in interventional radiology procedures
Blood pressure
To examine the effects of intra-procedure music on subjects' blood pressure in interventional radiology procedures
Amount of sedation required
To examine the effects of intra-procedure music on the amount of sedation required for subjects in interventional radiology procedures
Pain score
To examine the effects of intra-procedure music on the subjects' pain scores during interventional radiology procedures
RASS score
To examine the effects of intra-proceudre music on the subjects' RASS scores during interventional radiology procedures

Full Information

First Posted
August 22, 2018
Last Updated
July 7, 2020
Sponsor
NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT03665662
Brief Title
Effect of Intra-procedure Music on Anxiety
Official Title
Effect of Intra-procedure Music on Anxiety for Interventional Radiology Procedures
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
October 8, 2018 (Actual)
Primary Completion Date
February 28, 2020 (Actual)
Study Completion Date
February 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
139 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Patients in this arm will receive patient-selected music through headphones throughout their procedure.
Arm Title
Control
Arm Type
No Intervention
Arm 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.
Intervention Type
Other
Intervention Name(s)
Music
Intervention Description
Intra-procedure music through headphones
Primary Outcome Measure Information:
Title
State-Trait Anxiety Inventory (STAI) score
Description
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 Outcome Measure Information:
Title
Heart rate
Description
To examine the effects of intra-procedure music on subjects' heart rate in interventional radiology procedures
Time Frame
Up to 12 months
Title
Respiration rate
Description
To examine the effects of intra-procedure music on subjects' respiration rate in interventional radiology procedures
Time Frame
Up to 12 months
Title
Blood pressure
Description
To examine the effects of intra-procedure music on subjects' blood pressure in interventional radiology procedures
Time Frame
Up to 12 months
Title
Amount of sedation required
Description
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
Title
Pain score
Description
To examine the effects of intra-procedure music on the subjects' pain scores during interventional radiology procedures
Time Frame
Up to 12 months
Title
RASS score
Description
To examine the effects of intra-proceudre music on the subjects' RASS scores during interventional radiology procedures
Time Frame
Up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leora Horwitz, MD, MHS
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institutional Review Board Operations (IRB)
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Intra-procedure Music on Anxiety

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