Effect of Intra-procedure Music on Anxiety

• Sponsor: NYU Langone Health (Other)
• Overall Status: Completed
• CT.gov ID: NCT03665662
• Collaborator: (none)
• Enrollment: 139
• Location: 1
• Arms: 2
• Actual Duration (Months): 16.7
• Patients Per Site Per Month: 8.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Anxiety	Other: Music	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 139 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Care Provider)
• Primary Purpose: Health Services Research
• Official Title: Effect of Intra-procedure Music on Anxiety for Interventional Radiology Procedures
• Actual Study Start Date: Oct 8, 2018
• Actual Primary Completion Date: Feb 28, 2020
• Actual Study Completion Date: Feb 28, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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

1. Heart rate [Up to 12 months]

   To examine the effects of intra-procedure music on subjects' heart rate in interventional radiology procedures

2. Respiration rate [Up to 12 months]

   To examine the effects of intra-procedure music on subjects' respiration rate in interventional radiology procedures

3. Blood pressure [Up to 12 months]

   To examine the effects of intra-procedure music on subjects' blood pressure in interventional radiology procedures

4. 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

5. Pain score [Up to 12 months]

   To examine the effects of intra-procedure music on the subjects' pain scores during interventional radiology procedures

6. RASS score [Up to 12 months]

   To examine the effects of intra-proceudre music on the subjects' RASS scores during interventional radiology procedures

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institutional Review Board Operations (IRB)	New York	New York	United States	10016

Sponsors and Collaborators

• NYU Langone Health

Investigators

• Principal Investigator: Leora Horwitz, MD, MHS, NYU Langone Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT03665662
• Other Study ID Numbers: 18-01156
• First Posted: Sep 11, 2018
• Last Update Posted: Jul 9, 2020
• Last Verified: Jul 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Anxiety Disorders

Study Results

No Results Posted as of Jul 9, 2020