Patient SatisfactionNCT05728398
Music in Interventional Radiology Procedures
A study testing Music and No Music in people with Patient Satisfaction, run by Western University, Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Satisfaction
- What is being tested?
- Music and No Music
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2023to 31 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing an out-patient or non-emergent in-patient interventional radiology procedure
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Music in Interventional Radiology Procedures: Effect on Patient and Staff Experience
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.
- Conditions
- Patient Satisfaction
- Being tested
- Music, No Music
- Keywords
- Interventional radiology, Music, procedure sedation, patient experience
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MusicOther
Music played within the fluoroscopy suite during an interventional radiology procedure.
No MusicOther
No music played within the fluoroscopy suite during an interventional radiology procedure.
| Study group | Role | What they receive |
|---|---|---|
| Music Intervention Group | Active comparator | Participants randomized to receive music intervention during interventional radiology procedure. Receives: Other: Music |
| No Music Comparator Group | Sham comparator | Participants randomized to have no music played during interventional radiology procedure. Receives: Other: No Music |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural Sedation required
Dosage of Fentanyl and Midazolam required during interventional radiology procedure
Measured: Intra-procedure
Secondary outcomes (5)
Participant intra-procedural anxiety
Assess peri-procedural anxiety using State-Trait Anxiety Inventory scale
Measured: Intra-procedure
Participant procedural pain
Participant qualitative assessment of procedural pain using Visual Analog Scale (VAS)
Measured: Immediately post-procedure
Participant Procedural Experience
Participant Experience qualitative assessment using Likert scale
Measured: Immediately post-procedure
Interventional radiology procedure length
Measure the total time required to perform the IR procedure
Measured: Intra-procedure
Healthcare team experience
Assess procedural healthcare team's (physician, IR nurse, \& IR technologist) perceived impact of music on the procedure experience (Likert scale)
Measured: Immediately post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start1 Apr 2023 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient SatisfactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05728398
- Sponsor's protocol ID
- WESTERNU_IR 001
- Status last verified
- Feb 2023
- First submitted
- 12 Jul 2022
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Music in Interventional Radiology Procedures: Effect on Patient and Staff Experience
- ClinicalTrials.gov ID
- NCT05728398
- Acronym / sponsor ID
- WESTERNU_IR 001
- Conditions
- Patient Satisfaction
- Keywords
- Interventional radiology, Music, procedure sedation, patient experience
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 15 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music Intervention Group | Active comparator | Other: MusicParticipants randomized to receive music intervention during interventional radiology procedure. |
| No Music Comparator Group | Sham comparator | Other: No MusicParticipants randomized to have no music played during interventional radiology procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Undergoing an out-patient or non-emergent in-patient interventional radiology procedure
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MusicMusic played within the fluoroscopy suite during an interventional radiology procedure. | Other | Music Intervention Group |
| No MusicNo music played within the fluoroscopy suite during an interventional radiology procedure. | Other | No Music Comparator Group |
Primary outcome
Procedural Sedation required
Time frame: Intra-procedure
Dosage of Fentanyl and Midazolam required during interventional radiology procedure
5 secondary outcomes
Participant intra-procedural anxiety
Time frame: Intra-procedure
Participant procedural pain
Time frame: Immediately post-procedure
Participant Procedural Experience
Time frame: Immediately post-procedure
Interventional radiology procedure length
Time frame: Intra-procedure
Healthcare team experience
Time frame: Immediately post-procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Music and No Music in people with Patient Satisfaction, run by Western University, Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Derek W Cool, MD, PhD (5196858500 ext. 54965, derek.cool@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedural Sedation required (time frame: Intra-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2023; AzTrials last refreshed its copy on 30 Oct 2026.