UrolithiasisNCT04338451
Music During ESWL for Half Treatment
A study testing Music during the first part of ESWL and Music during the second part of ESWL in people with Urolithiasis, run by A.O.U. Città della Salute e della Scienza at 1 site in Italy.
Trial summary
The aim of this study is to evaluate if music listening relieves pain and discomfort during Extracorporeal Shock-Waves Lithotripsy (ESWL). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Urolithiasis
- What is being tested?
- Music during the first part of ESWL and Music during the second part of ESWL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteItaly
- Study dates
- 2 Feb 2017to 25 Oct 2017
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients undergoing ESWL from February 2011 to October 2012 and interested in music listening
Who cannot join
- Contraindication to ESWL
- No interest in music listening
- < 18 years and > 80 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Music Listening to Decrease Pain and Discomfort During Extracorporeal Shock Wave Lithotripsy (SWL): a Prospective Randomized Trial.
The aim of this study is to evaluate if music listening relieves pain and discomfort during Extracorporeal Shock-Waves Lithotripsy (ESWL).
Read the detailed description
Patients undergoing ESWL and interested in music listening are randomly divided in two groups: patients in group A listen to music during the first part of the treatment (first 1800 SW), patients in group B during the second part.
At the end of the treatment patients are asked to fill in a questionnaire. They are asked if they were pleased to have had the opportunity to listen to music during ESWL, if they would like to listen to music again in case of further treatments, if they consider music helpful in relieving pain and discomfort during ESWL. Patients are also asked to mark their level of pain during each part of the treatment on a visual analogue scale (VAS) for pain.
- Conditions
- Urolithiasis
- Being tested
- Music during the first part of ESWL, Music during the second part of ESWL
- Keywords
- Urolithiasis, Kidney Calculi, Lithotripsy, Pain Management, Music
- Medical subject headings
- Urolithiasis, Kidney Calculi, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music during the first part of ESWLOther
Music listening during first part of ESWL
Music during the second part of ESWLOther
Music listening during second part of ESWL
| Study group | Role | What they receive |
|---|---|---|
| Music during the first part of ESWL | Active comparator | Patients listen to music during the first part of ESWL treatment (first 1800 SW). Receives: Other: Music during the first part of ESWL |
| Music during the second part of ESWL | Active comparator | Patients listen to music during the second part of ESWL treatment. Receives: Other: Music during the second part of ESWL |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of patients who appreciated music listening during SWL without anesthesia
patients were asked if they appreciated music listening during swl
Measured: 10 mins after SWL treatment completed
Secondary outcomes (6)
percentage of patients who considered music useful to relieve pain
patients were asked if they considered music useful to relieve pain during swl
Measured: 10 mins after SWL treatment completed
change in SW voltage (kV)
change in SW voltage (kV)
Measured: 10 mins after SWL treatment completed
change in VAS score
Visual analogue scale (VAS) - 0 to 10, higher values, worse pain
Measured: 10 mins after SWL treatment completed
change in analgesic request
change in analgesic request
Measured: 10 mins after SWL treatment completed
change in requested interruptions
change in requested interruptions
Measured: 10 mins after SWL treatment completed
change on VAS scores separately measured in each part of the treatment
Visual analogue scale (VAS) - 0 to 10, higher values, worse pain
Measured: 10 mins after SWL treatment completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2020
- Study start2 Feb 2017
- Primary completion25 Oct 2017
- Study completion25 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UrolithiasisStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- A.O.U. Città della Salute e della Scienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Bosio, A.O.U. Città della Salute e della Scienza
- Investigators
- Andrea MD Bosio, MD, Study chair, AOU città dellaSalute e della Scienza, TorinoAndrea MD Bosio, MD, Principal investigator, AOU città dellaSalute e della Scienza, TorinoAndrea MD Bosio, MD, Study director, AOU città dellaSalute e della Scienza, Torino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04338451
- Sponsor's protocol ID
- AOUCSSTURAB001
- Status last verified
- Apr 2020
- First submitted
- 4 Dec 2015
- Last updated
- 8 Apr 2020
- 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 8 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Music Listening to Decrease Pain and Discomfort During Extracorporeal Shock Wave Lithotripsy (SWL): a Prospective Randomized Trial.
- ClinicalTrials.gov ID
- NCT04338451
- Acronym / sponsor ID
- AOUCSSTURAB001
- Conditions
- Urolithiasis
- Keywords
- Urolithiasis, Kidney Calculi, Lithotripsy, Pain Management, Music
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- A.O.U. Città della Salute e della ScienzaUniversity, hospital or other
- Study start
- 2 Feb 2017 (actual)
- Primary completion
- 25 Oct 2017 (actual)
- Study completion
- 25 Oct 2017 (actual)
- First posted
- 8 Apr 2020 (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 aim of this study is to evaluate if music listening relieves pain and discomfort during Extracorporeal Shock-Waves Lithotripsy (ESWL).
Detailed description
Patients undergoing ESWL and interested in music listening are randomly divided in two groups: patients in group A listen to music during the first part of the treatment (first 1800 SW), patients in group B during the second part.
At the end of the treatment patients are asked to fill in a questionnaire. They are asked if they were pleased to have had the opportunity to listen to music during ESWL, if they would like to listen to music again in case of further treatments, if they consider music helpful in relieving pain and discomfort during ESWL. Patients are also asked to mark their level of pain during each part of the treatment on a visual analogue scale (VAS) for pain.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music during the first part of ESWL | Active comparator | Other: Music during the first part of ESWLPatients listen to music during the first part of ESWL treatment (first 1800 SW). |
| Music during the second part of ESWL | Active comparator | Other: Music during the second part of ESWLPatients listen to music during the second part of ESWL treatment. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients undergoing ESWL from February 2011 to October 2012 and interested in music listening
Key exclusion criteria (3 listed)
- Contraindication to ESWL
- No interest in music listening
- < 18 years and > 80 years
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 |
|---|---|---|
| Music during the first part of ESWLMusic listening during first part of ESWL | Other | Music during the first part of ESWL |
| Music during the second part of ESWLMusic listening during second part of ESWL | Other | Music during the second part of ESWL |
Primary outcome
percentage of patients who appreciated music listening during SWL without anesthesia
Time frame: 10 mins after SWL treatment completed
patients were asked if they appreciated music listening during swl
6 secondary outcomes
percentage of patients who considered music useful to relieve pain
Time frame: 10 mins after SWL treatment completed
change in SW voltage (kV)
Time frame: 10 mins after SWL treatment completed
change in VAS score
Time frame: 10 mins after SWL treatment completed
change in analgesic request
Time frame: 10 mins after SWL treatment completed
change in requested interruptions
Time frame: 10 mins after SWL treatment completed
change on VAS scores separately measured in each part of the treatment
Time frame: 10 mins after SWL treatment completed
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2020.
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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.
Andrea MD Bosio, MD study chair
AOU città dellaSalute e della Scienza, Torino
Andrea MD Bosio, MD principal investigator
AOU città dellaSalute e della Scienza, Torino
Andrea MD Bosio, MD study director
AOU città dellaSalute e della Scienza, Torino
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music during the first part of ESWL and Music during the second part of ESWL in people with Urolithiasis, run by A.O.U. Città della Salute e della Scienza at 1 site in Italy.
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 3 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: finished, as of the sponsor's last update on 8 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of patients who appreciated music listening during SWL without anesthesia (time frame: 10 mins after SWL treatment completed). 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 8 Apr 2020.