Coronary AngioplastyNCT03817775
Effect of Music on the Sedative Use During Coronary Angioplasty
A study testing Music therapy in people with Coronary Angioplasty, run by Association de Musicothérapie Applications et Recherches Cliniques at 1 site in France.
Trial summary
This is a non-blinded, non-randomized controlled pilot study with no follow-up. Patients will be recruited from the coronary angiography patient pool of the American Hospital of Paris and assigned to one of 2 groups in a non-randomized manner. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Angioplasty
- What is being tested?
- Music therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteFrance
- Study dates
- 31 Jan 2019to 3 Apr 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patient needs a coronary angiography
- Patient gives verbal consent to participation in the study.
Who cannot join
- Patient aged less than 18 years at time of enrollment
- Patient doesn't like music for cultural reason
- Patient with serious psychiatric disorders
- Patient with not paired deafness or paired one with devices that are incompatible with wearing a headset.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Music on the Reduction of the Sedative Dose During Coronary Angioplasty: A Control-case Comparison Clinical Study
This is a non-blinded, non-randomized controlled pilot study with no follow-up. Patients will be recruited from the coronary angiography patient pool of the American Hospital of Paris and assigned to one of 2 groups in a non-randomized manner.
Read the detailed description
This is a non-blinded, non-randomized controlled pilot study with patients who will be followed during their coronary angiography procedure and with no follow-up. Patients will be recruited from the coronary angiography patient pool of the American Hospital of Paris and assigned to one of 2 groups in a non-randomized manner. It is expected to enroll around 100 patients and this is estimated to be obtained in a period of 2 months approximately. Patients will be placed in the control group, without music intervention, or assigned to the music group. Assignment will be done in this manner due to limited availability of the hardware and software to the investigation team. Patients in both groups will be matched based on age, sex, weight, height, American Society of Anesthesiology (ASA) score, and prior medical history, including diabetes, hypertension, chronic kidney disease and stroke. Each patient will receive a standardized sedation in the traditional manner and at the discretion of the investigator to reach Bispectral index (BIS) score below 90 and sedation score ≤ 1. The primary study end points will be the consumptions in analgesics and hypnotics. Secondary study end points will be pain and anxiety scores as measured the Numeric Rating Scale (NRS), the Visual Analog Scale (VAS) and the Amsterdam Preoperative Anxiety and Information Scale (APAIS).
- Conditions
- Coronary Angioplasty
- Being tested
- Music therapy
- Keywords
- Music therapy, sedation, coronary angioplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music therapyOther
The intervention group will administer "U" sequence between 10 minutes prior to the beginning of the procedure until its end.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | The control group will undergo coronary angiography without music intervention. |
| Music therapy | Experimental | The intervention group will also undergo coronary angiography and will administer music therapy between 10 minutes prior to the beginning of the procedure until its end. Receives: Other: Music therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Use of Midazolam Medication (mg)
The consumption in Midazolam medication was reported during the coronary angioplasty. Dose was in mg.
Measured: Between 10 minutes prior to the beginning of the procedure up to 45 minutes.
Dose Use of Propofol Medication (mg)
The consumption in Propofol medication was reported during the coronary angioplasty. Dose was in mg.
Measured: Between 10 minutes prior to the beginning of the procedure up to 45 minutes.
Dose Use of Sufentanil Medication (ug)
The consumption in Sufentanil medication was reported during the coronary angioplasty. Dose was in ug.
Measured: Between 10 minutes prior to the beginning of the procedure up to 45 minutes.
Secondary outcomes (7)
Pain Score
Pain score was measured using the Visual Analog Scale (VAS). This scale ranged from 0 (no pain) to 10 (very high pain), and collected the maximum pain the patient had during the procedure. This was collected right after the end of the procedure in the recovery room.
Measured: From 0 up to 45 minutes.
Anxiety Score (NRS)
Anxiety score was measured using the Numeric Rating Scale (NRS). This scale ranged from 0 (no anxiety) to 10 (very high anxiety), and collected the maximum anxiety the patient had during the procedure. This was collected right after the end of the procedure in the recovery room.
Measured: From 0 up to 45 minutes.
Satisfaction of the Patient
Satisfaction was measured using a scale from 0 to 5, with a higher score for a high satisfaction.
Measured: Right after the end of the procedure in the recovery room.
Effect on Physiological Parameters: BIS
Bispectral index (BIS) score at baseline which corresponds to 10 minutes before the beginning of the procedure.
The BIS monitor provides a single dimensionless number which ranges from 0 (equivalent to EEG silence) to 100. Higher is the score, better it is.
Measured: 10 minutes prior to the beginning of the procedure
Effect on Physiological Parameters: Heart Rate
Heart rate at Baseline which corresponds to 10 minutes before the beginning of the procedure.
Measured: 10 minutes prior to the beginning of the procedure.
Effect on Physiological Parameters: SpO2%
SpO2 at Baseline which corresponds to 10 minutes before the beginning of the procedure..
Measured: 10 minutes prior to the beginning of the procedure.
Effect on Physiological Parameters: Mean Arterial Blood Pressure
Mean arterial blood pressure at Baseline which corresponds to 10 minutes before the beginning of the procedure.
Measured: 10 minutes prior to the beginning of the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2019
- Study start31 Jan 2019
- Primary completion3 Apr 2019
- Study completion3 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Coronary AngioplastyStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be recruited from the coronary angiography patient pool of the American Hospital of Paris and assigned to one of 2 groups in a non-randomized manner: Control or music intervention.
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association de Musicothérapie Applications et Recherches Cliniques
- Sponsor type
- University, hospital or other
- Collaborators
- American Hospital of Paris
- Responsible party
- Sponsor
- Investigators
- Gilles BOCCARA, PhD, Principal investigator, Department of Anaesthesia and Intensive Care, American Hospital of Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03817775
- Sponsor's protocol ID
- MusicSeda
- Status last verified
- Oct 2019
- First submitted
- 12 Jan 2019
- Last updated
- 21 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jaber S, Bahloul H, Guetin S, Chanques G, Sebbane M, Eledjam JJ. [Effects of music therapy in intensive care unit without sedation in weaning patients versus non-ventilated patients]. Ann Fr Anesth Reanim. 2007 Jan;26(1):30-8. doi: 10.1016/j.annfar.2006.09.002. Epub 2006 Nov 3. French.
PubMed 17085009Guetin S, Ginies P, Siou DK, Picot MC, Pommie C, Guldner E, Gosp AM, Ostyn K, Coudeyre E, Touchon J. The effects of music intervention in the management of chronic pain: a single-blind, randomized, controlled trial. Clin J Pain. 2012 May;28(4):329-37. doi: 10.1097/AJP.0b013e31822be973.
PubMed 22001666Messika J, Hajage D, Panneckoucke N, Villard S, Martin Y, Renard E, Blivet A, Reignier J, Maquigneau N, Stoclin A, Puechberty C, Guetin S, Dechanet A, Fauquembergue A, Gaudry S, Dreyfuss D, Ricard JD. Effect of a musical intervention on tolerance and efficacy of non-invasive ventilation in the ICU: study protocol for a randomized controlled trial (MUSique pour l'Insuffisance Respiratoire Aigue - Mus-IRA). Trials. 2016 Sep 13;17(1):450. doi: 10.1186/s13063-016-1574-z.
PubMed 27618935Guetin S, Brun L, Deniaud M, Clerc JM, Thayer JF, Koenig J. Smartphone-based Music Listening to Reduce Pain and Anxiety Before Coronarography: A Focus on Sex Differences. Altern Ther Health Med. 2016 Jul;22(4):60-3.
PubMed 27548494
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Music on the Reduction of the Sedative Dose During Coronary Angioplasty: A Control-case Comparison Clinical Study
- ClinicalTrials.gov ID
- NCT03817775
- Acronym / sponsor ID
- MusicSeda
- Conditions
- Coronary Angioplasty
- Keywords
- Music therapy, sedation, coronary angioplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Association de Musicothérapie Applications et Recherches CliniquesUniversity, hospital or other
- Collaborators
- American Hospital of Paris
- Study start
- 31 Jan 2019 (actual)
- Primary completion
- 3 Apr 2019 (actual)
- Study completion
- 3 Apr 2019 (actual)
- First posted
- 25 Jan 2019 (actual)
- Results
- Posted 2 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a non-blinded, non-randomized controlled pilot study with no follow-up. Patients will be recruited from the coronary angiography patient pool of the American Hospital of Paris and assigned to one of 2 groups in a non-randomized manner.
Detailed description
This is a non-blinded, non-randomized controlled pilot study with patients who will be followed during their coronary angiography procedure and with no follow-up. Patients will be recruited from the coronary angiography patient pool of the American Hospital of Paris and assigned to one of 2 groups in a non-randomized manner. It is expected to enroll around 100 patients and this is estimated to be obtained in a period of 2 months approximately. Patients will be placed in the control group, without music intervention, or assigned to the music group. Assignment will be done in this manner due to limited availability of the hardware and software to the investigation team. Patients in both groups will be matched based on age, sex, weight, height, American Society of Anesthesiology (ASA) score, and prior medical history, including diabetes, hypertension, chronic kidney disease and stroke. Each patient will receive a standardized sedation in the traditional manner and at the discretion of the investigator to reach Bispectral index (BIS) score below 90 and sedation score ≤ 1. The primary study end points will be the consumptions in analgesics and hypnotics. Secondary study end points will be pain and anxiety scores as measured the Numeric Rating Scale (NRS), the Visual Analog Scale (VAS) and the Amsterdam Preoperative Anxiety and Information Scale (APAIS).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be recruited from the coronary angiography patient pool of the American Hospital of Paris and assigned to one of 2 groups in a non-randomized manner: Control or music intervention.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –The control group will undergo coronary angiography without music intervention. |
| Music therapy | Experimental | Other: Music therapyThe intervention group will also undergo coronary angiography and will administer music therapy between 10 minutes prior to the beginning of the procedure until its end. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient needs a coronary angiography
- Patient gives verbal consent to participation in the study.
Key exclusion criteria (4 listed)
- Patient aged less than 18 years at time of enrollment
- Patient doesn't like music for cultural reason
- Patient with serious psychiatric disorders
- Patient with not paired deafness or paired one with devices that are incompatible with wearing a headset.
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 therapyThe intervention group will administer "U" sequence between 10 minutes prior to the beginning of the procedure until its end. | Other | Music therapy |
Primary outcome
Dose Use of Midazolam Medication (mg)
Time frame: Between 10 minutes prior to the beginning of the procedure up to 45 minutes.
The consumption in Midazolam medication was reported during the coronary angioplasty. Dose was in mg.
Dose Use of Propofol Medication (mg)
Time frame: Between 10 minutes prior to the beginning of the procedure up to 45 minutes.
The consumption in Propofol medication was reported during the coronary angioplasty. Dose was in mg.
Dose Use of Sufentanil Medication (ug)
Time frame: Between 10 minutes prior to the beginning of the procedure up to 45 minutes.
The consumption in Sufentanil medication was reported during the coronary angioplasty. Dose was in ug.
7 secondary outcomes
Pain Score
Time frame: From 0 up to 45 minutes.
Anxiety Score (NRS)
Time frame: From 0 up to 45 minutes.
Satisfaction of the Patient
Time frame: Right after the end of the procedure in the recovery room.
Effect on Physiological Parameters: BIS
Time frame: 10 minutes prior to the beginning of the procedure
Effect on Physiological Parameters: Heart Rate
Time frame: 10 minutes prior to the beginning of the procedure.
Effect on Physiological Parameters: SpO2%
Time frame: 10 minutes prior to the beginning of the procedure.
Effect on Physiological Parameters: Mean Arterial Blood Pressure
Time frame: 10 minutes prior to the beginning of the procedure.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17085009Jaber S, Bahloul H, Guetin S, Chanques G, Sebbane M, Eledjam JJ. [Effects of music therapy in intensive care unit without sedation in weaning patients versus non-ventilated patients]. Ann Fr Anesth Reanim. 2007 Jan;26(1):30-8. doi: 10.1016/j.annfar.2006.09.002. Epub 2006 Nov 3. French.
- Background: PubMed 22001666Guetin S, Ginies P, Siou DK, Picot MC, Pommie C, Guldner E, Gosp AM, Ostyn K, Coudeyre E, Touchon J. The effects of music intervention in the management of chronic pain: a single-blind, randomized, controlled trial. Clin J Pain. 2012 May;28(4):329-37. doi: 10.1097/AJP.0b013e31822be973.
- Background: PubMed 27618935Messika J, Hajage D, Panneckoucke N, Villard S, Martin Y, Renard E, Blivet A, Reignier J, Maquigneau N, Stoclin A, Puechberty C, Guetin S, Dechanet A, Fauquembergue A, Gaudry S, Dreyfuss D, Ricard JD. Effect of a musical intervention on tolerance and efficacy of non-invasive ventilation in the ICU: study protocol for a randomized controlled trial (MUSique pour l'Insuffisance Respiratoire Aigue - Mus-IRA). Trials. 2016 Sep 13;17(1):450. doi: 10.1186/s13063-016-1574-z.
- Background: PubMed 27548494Guetin S, Brun L, Deniaud M, Clerc JM, Thayer JF, Koenig J. Smartphone-based Music Listening to Reduce Pain and Anxiety Before Coronarography: A Focus on Sex Differences. Altern Ther Health Med. 2016 Jul;22(4):60-3.
- Individual participant dataSharing planned: No
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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.
Gilles BOCCARA, PhD principal investigator
Department of Anaesthesia and Intensive Care, American Hospital of Paris
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 therapy in people with Coronary Angioplasty, run by Association de Musicothérapie Applications et Recherches Cliniques at 1 site in France.
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 2 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: finished, as of the sponsor's last update on 21 Oct 2019. 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 France. 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?
Yes. Results are posted in the registry (first posted 2 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Dose Use of Midazolam Medication (mg) (time frame: Between 10 minutes prior to the beginning of the procedure up to 45 minutes.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03817775, which also lists 4 linked publications.
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 21 Oct 2019.