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OpenTrials
Completed

NCT Number: NCT03665662

Effect of Intra-procedure Music on Anxiety

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.

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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institutional Review Board Operations (IRB)

New York, 10016, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Music

Other

Intra-procedure music through headphones

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 11, 2018
Registry last updated
Jul 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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