Effect of Intra-procedure Music on Anxiety

NCT03665662 | Completed

• 1 other identifier: 18-01156
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Heart rate

  Up to 12 months

• Respiration rate

  Up to 12 months

• Blood pressure

  Up to 12 months

• Amount of sedation required

  Up to 12 months

• Pain score

  Up to 12 months

Study Arms (2)

Intervention

EXPERIMENTAL

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

Other: Music

Control

NO INTERVENTION

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.

Interventions

Music OTHER

Intra-procedure music through headphones

Intervention

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Not a moderate sedation candidate (hemodynamically unfit, not optimized for procedure, pregnant)

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

Institutional Review Board Operations (IRB)

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Leora Horwitz, MD, MHS

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2018
• First Posted: September 11, 2018
• Study Start: October 8, 2018
• Primary Completion: February 28, 2020
• Study Completion: February 28, 2020
• Last Updated: July 9, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)