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Effect of Intra-procedure Music on Anxiety

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ClinicalTrials.gov Identifier: NCT03665662
Recruitment Status : Recruiting
First Posted : September 11, 2018
Last Update Posted : January 25, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Anxiety Other: Music Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 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 : October 8, 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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.



Primary Outcome Measures :
  1. State-Trait Anxiety Inventory (STAI) score [ Time Frame: 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 [ Time Frame: Up to 12 months ]
    To examine the effects of intra-procedure music on subjects' heart rate in interventional radiology procedures

  2. Respiration rate [ Time Frame: Up to 12 months ]
    To examine the effects of intra-procedure music on subjects' respiration rate in interventional radiology procedures

  3. Blood pressure [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Up to 12 months ]
    To examine the effects of intra-procedure music on the subjects' pain scores during interventional radiology procedures

  6. RASS score [ Time Frame: Up to 12 months ]
    To examine the effects of intra-proceudre music on the subjects' RASS scores during interventional radiology procedures



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03665662


Contacts
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Contact: Emma Simon, BS 646-501-2917 emma.simon@nyumc.org
Contact: Richard Ehrhardt, BSN, RN 646-887-4893 richard.ehrhardt@nyumc.org

Locations
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United States, New York
Institutional Review Board Operations (IRB) Recruiting
New York, New York, United States, 10016
Contact: Emma Simon    646-501-2685    emma.simon@nyulangone.org   
Principal Investigator: Leora Horwitz, MD         
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Leora Horwitz, MD, MHS NYU Langone Health

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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03665662     History of Changes
Other Study ID Numbers: 18-01156
First Posted: September 11, 2018    Key Record Dates
Last Update Posted: January 25, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders