AnxietyMUSIC-CATNCT03398525
Musical Intervention and Patient's Anxiety During Central Venous Catheter Insertion in the Intensive Care Unit
A study testing Musical intervention in people with Anxiety and Pain, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
Trial summary
Intensive care unit patients who have to undergo central venous catheter insertion and are able to hear explanations and to gave consent, will be randomized to either usual care during catheter insertion or to a musical intervention added to usual care. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Musical intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteFrance
- Study dates
- 2 Feb 2018to 7 Feb 2019
- 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
- patient hospitalized in the intensive care unit or high-dependency unit
- patient for whom a central venous catheter insertion is envisaged
- patient capable of hearing and understanding explanations and able to consent
Who cannot join
- severe hearing loss
- allergy to local anesthetic drug
- pregnancy
- lack of social security number
- patient under guardianship
- previous participation to the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a Musical Intervention in the Intensive Care Unit During the Implantation of a Central Venous Access or a Dialysis Catheter: A Prospective, Randomized Pilot Study
Intensive care unit patients who have to undergo central venous catheter insertion and are able to hear explanations and to gave consent, will be randomized to either usual care during catheter insertion or to a musical intervention added to usual care.
The primary objective will be to assess the patient's anxiety just after catheter insertion. Secondary outcome measures will be the patient-reported pain, the duration of catheter insertion, and the need for additional anxiolytic or sedative drugs during catheter insertion.
Read the detailed description
Patient informed consent will be obtained before any other study specific procedure.
Computer-generated randomization with 1:1 allocation ratio will be stratified by the site of catheter insertion (superior vena cava or femoral), and by the ventilatory status (patient mechanically ventilated or not). Block size, not known by the investigators, of 4 or 6 will be used. Randomization group for each patient will be kept concealed into sealed opaque envelops until inclusion once consent obtained.
Anxiety, the primary outcome measure, and pain related to the catheter insertion will be assessed using two distinct Visual Analogic Scales.
In the usual care group, the catheter will be inserted using the Seldinger method, under local anesthesia with 2% lidocaine, with ultrasound guidance, after proper skin antisepsis, surgical operator's hand washing and antisepsis, and use of sterile drapes, gowns and gloves.
In the intervention group, in addition to the usual care procedures as described above, a musical U-shaped session will be delivered to the patient through headphones, using a tablet computer and the "MUSIC CARE" music program, a validated program for use in health care.
- Being tested
- usual care, Musical intervention
- Keywords
- central venous catheter, intensive care, music therapy
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
usual careOther
usual care following local standard operational procedures
Musical interventionOther
Musical intervention using a marketed music program validated for music therapy
| Study group | Role | What they receive |
|---|---|---|
| Usual care | Active comparator | After patient information, appropriate skin antisepsis according to local procedures, surgical hand antisepsis by the operator, use of sterile drapes, gowns and gloves, insertion of a central venous catheter after after local anesthesia with 2% lidocaine, using ultrasound guidance. Receives: Other: usual care |
| Musical intervention | Experimental | After patient information, appropriate skin antisepsis according to local procedures, surgical hand antisepsis by the operator, use of sterile drapes, gowns and gloves, insertion of a central venous catheter after after local anesthesia with 2% lidocaine, using ultrasound guidance.
In addition, a U-shaped music program (MUSIC CARE, trade mark) will be delivered to the patient through headphones throughout the catheter insertion procedure beginning with the operator's hand washing and ending once the dressing is put on the catheter insertion site. Receives: Other: usual care; Other: Musical intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
anxiety assessed using a visual analog scale (VAS)
self-reported patient's anxiety assessed using a 100mm-visual analog scale, extending from 0 mm ("no anxiety") to 100 mm ("worst anxiety ever experienced")
Measured: 30 minutes
Secondary outcomes (2)
pain assessed using a visual analog scale (VAS)
self-reported patient's pain assessed using a 100mm-visual analog scale, extending from 0 mm ("no pain") to 100 mm ("the worst pain possible")
Measured: 30 minutes
duration of the catheter insertion
started with local anesthesia and ending with the application of the dressing on catheter insertion site.
Measured: 10-30 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2018
- Study start2 Feb 2018
- Primary completion7 Feb 2019
- Study completion7 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomization with 1:1 allocation ratio
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional d'Orléans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mai-Ahn Nay, MD, Principal investigator, CHR Orléans, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03398525
- Sponsor's protocol ID
- CHRO-2017-11
- Other IDs
- IDRCB number: 2017-A02536-47
- Acronym
- MUSIC-CAT
- Status last verified
- May 2019
- First submitted
- 8 Jan 2018
- Last updated
- 6 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jacquier S, Nay MA, Muller G, Muller L, Mathonnet A, Lefevre-Benzekri D, Bretagnol A, Barbier F, Kamel T, Runge I, Skarzynski M, Sauvage B, Boulain T. Effect of a Musical Intervention During the Implantation of a Central Venous Catheter or a Dialysis Catheter in the Intensive Care Unit: A Prospective Randomized Pilot Study. Anesth Analg. 2022 Apr 1;134(4):781-790. doi: 10.1213/ANE.0000000000005696.
PubMed 35299213
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Musical Intervention in the Intensive Care Unit During the Implantation of a Central Venous Access or a Dialysis Catheter: A Prospective, Randomized Pilot Study
- ClinicalTrials.gov ID
- NCT03398525
- Acronym / sponsor ID
- MUSIC-CAT / CHRO-2017-11
- Keywords
- central venous catheter, intensive care, music therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional d'OrléansUniversity, hospital or other
- Study start
- 2 Feb 2018 (actual)
- Primary completion
- 7 Feb 2019 (actual)
- Study completion
- 7 Feb 2019 (actual)
- First posted
- 12 Jan 2018 (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.
Intensive care unit patients who have to undergo central venous catheter insertion and are able to hear explanations and to gave consent, will be randomized to either usual care during catheter insertion or to a musical intervention added to usual care.
The primary objective will be to assess the patient's anxiety just after catheter insertion. Secondary outcome measures will be the patient-reported pain, the duration of catheter insertion, and the need for additional anxiolytic or sedative drugs during catheter insertion.
Detailed description
Patient informed consent will be obtained before any other study specific procedure.
Computer-generated randomization with 1:1 allocation ratio will be stratified by the site of catheter insertion (superior vena cava or femoral), and by the ventilatory status (patient mechanically ventilated or not). Block size, not known by the investigators, of 4 or 6 will be used. Randomization group for each patient will be kept concealed into sealed opaque envelops until inclusion once consent obtained.
Anxiety, the primary outcome measure, and pain related to the catheter insertion will be assessed using two distinct Visual Analogic Scales.
In the usual care group, the catheter will be inserted using the Seldinger method, under local anesthesia with 2% lidocaine, with ultrasound guidance, after proper skin antisepsis, surgical operator's hand washing and antisepsis, and use of sterile drapes, gowns and gloves.
In the intervention group, in addition to the usual care procedures as described above, a musical U-shaped session will be delivered to the patient through headphones, using a tablet computer and the "MUSIC CARE" music program, a validated program for use in health care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomization with 1:1 allocation ratio
| Arm | Type | Receives |
|---|---|---|
| Usual care | Active comparator | Other: usual careAfter patient information, appropriate skin antisepsis according to local procedures, surgical hand antisepsis by the operator, use of sterile drapes, gowns and gloves, insertion of a central venous catheter after after local anesthesia with 2% lidocaine, using ultrasound guidance. |
| Musical intervention | Experimental | Other: usual care, Other: Musical interventionAfter patient information, appropriate skin antisepsis according to local procedures, surgical hand antisepsis by the operator, use of sterile drapes, gowns and gloves, insertion of a central venous catheter after after local anesthesia with 2% lidocaine, using ultrasound guidance. In addition, a U-shaped music program (MUSIC CARE, trade mark) will be delivered to the patient through headphones throughout the catheter insertion procedure beginning with the operator's hand washing and ending once the dressing is put on the catheter insertion site. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patient hospitalized in the intensive care unit or high-dependency unit
- patient for whom a central venous catheter insertion is envisaged
- patient capable of hearing and understanding explanations and able to consent
Key exclusion criteria (6 listed)
- severe hearing loss
- allergy to local anesthetic drug
- pregnancy
- lack of social security number
- patient under guardianship
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 |
|---|---|---|
| usual careusual care following local standard operational procedures | Other | Musical intervention, Usual care |
| Musical interventionMusical intervention using a marketed music program validated for music therapy | Other | Musical intervention |
Primary outcome
anxiety assessed using a visual analog scale (VAS)
Time frame: 30 minutes
self-reported patient's anxiety assessed using a 100mm-visual analog scale, extending from 0 mm ("no anxiety") to 100 mm ("worst anxiety ever experienced")
2 secondary outcomes
pain assessed using a visual analog scale (VAS)
Time frame: 30 minutes
duration of the catheter insertion
Time frame: 10-30 min
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 6 May 2019.
- Derived from this study: PubMed 35299213Jacquier S, Nay MA, Muller G, Muller L, Mathonnet A, Lefevre-Benzekri D, Bretagnol A, Barbier F, Kamel T, Runge I, Skarzynski M, Sauvage B, Boulain T. Effect of a Musical Intervention During the Implantation of a Central Venous Catheter or a Dialysis Catheter in the Intensive Care Unit: A Prospective Randomized Pilot Study. Anesth Analg. 2022 Apr 1;134(4):781-790. doi: 10.1213/ANE.0000000000005696.
- Individual participant dataSharing planned: No
Related trials for Anxiety
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
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.
Mai-Ahn Nay, MD principal investigator
CHR Orléans, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Musical intervention in people with Anxiety and Pain, run by Centre Hospitalier Régional d'Orléans 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 3 inclusion and 6 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 6 May 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?
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?
anxiety assessed using a visual analog scale (VAS) (time frame: 30 minutes). 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 NCT03398525, which also lists 1 linked publication.
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 6 May 2019.