NCT05728398

Brief Summary

The use of music as medical therapy for the treatment of mental health conditions like depression and anxiety is well established. Furthermore, music is sometimes played in operating rooms and several small single center studies done during cardiology and interventional radiology procedures have demonstrated that the use of music can decrease in the use of sedation medications, pain, and anxiety during the procedures. These past studies have only looked at the impact on the participants, as the music was delivered to the participants only through headphones. This means that the impact of music on the healthcare team was not studied. However, separate systematic literature reviews on the impact of playing music in operating rooms during surgical procedures have highlighted some positive effects music has on the surgeon and the surgical team. The purpose of this study is to evaluate the effects of playing music during interventional radiology procedures on the participants and the healthcare team. One way of studying this is to compare the responses and experience of participants and healthcare team that hear ambient music during the procedure with those who did not.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2022

Completed
7 months until next milestone

First Posted

Study publicly available on registry

February 15, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
Last Updated

February 15, 2023

Status Verified

February 1, 2023

Enrollment Period

9 months

First QC Date

July 12, 2022

Last Update Submit

February 13, 2023

Conditions

Keywords

Interventional radiologyMusicprocedure sedationpatient experience

Outcome Measures

Primary Outcomes (1)

  • Procedural Sedation required

    Dosage of Fentanyl and Midazolam required during interventional radiology procedure

    Intra-procedure

Secondary Outcomes (5)

  • Participant intra-procedural anxiety

    Intra-procedure

  • Participant procedural pain

    Immediately post-procedure

  • Participant Procedural Experience

    Immediately post-procedure

  • Interventional radiology procedure length

    Intra-procedure

  • Healthcare team experience

    Immediately post-procedure

Study Arms (2)

Music Intervention Group

ACTIVE COMPARATOR

Participants randomized to receive music intervention during interventional radiology procedure.

Other: Music

No Music Comparator Group

SHAM COMPARATOR

Participants randomized to have no music played during interventional radiology procedure.

Other: No Music

Interventions

MusicOTHER

Music played within the fluoroscopy suite during an interventional radiology procedure.

Music Intervention Group

No music played within the fluoroscopy suite during an interventional radiology procedure.

No Music Comparator Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Undergoing an out-patient or non-emergent in-patient interventional radiology procedure

You may not qualify if:

  • Participants unable to consent or complete survey information
  • Participants receiving procedures under general anesthesia
  • Participants unable to receive IV conscious sedation
  • Emergent cases or those performed outside of routine hospital hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Patient Satisfaction

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Central Study Contacts

Derek W Cool, MD, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2022

First Posted

February 15, 2023

Study Start

April 1, 2023

Primary Completion

December 31, 2023

Study Completion

January 31, 2024

Last Updated

February 15, 2023

Record last verified: 2023-02