C.Surgical ProcedureMATHNCT04172662
Music Therapy as an Adjunct in CIED Lead Extraction Procedures
A study testing Facilitated Music Listening in people with C.Surgical Procedure and Stress, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The study will investigate possible effects of music therapy as an adjunct in an invasive cardiac procedure where infected or broken pacemaker leads, or leads from implantable cardioverter-defibrillators are removed from inside the heart through the vein. Read more about this study
- Who is it for?
- Ages 25 to 80 years
- Conditions the study is for
- C.Surgical Procedure, Stress, Pain, Procedural
- What is being tested?
- Facilitated Music Listening
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteNorway
- Study dates
- 1 Mar 2018to 27 Sep 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 25 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Planned pacemaker or intracardiac defibrillator (ICD) lead extraction performed in local anaesthesia.
- Lead implanted > 12 months ago
- Able to speak and read Norwegian
- Willing to participate All inclusion criteria must be fulfilled.
Who cannot join
- Significant hearing impairment
- Previous and/or acute psychiatric diagnosis
- Cognitive and mental deficits or impaired functioning
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Music Therapy as an Adjunct in Cardiac Implantable Electronic Device (CIED) Lead Extraction Procedures
The study will investigate possible effects of music therapy as an adjunct in an invasive cardiac procedure where infected or broken pacemaker leads, or leads from implantable cardioverter-defibrillators are removed from inside the heart through the vein. The procedure is performed in local anaesthesia with the patient awake. Analgesic and anxiolytic drugs are given at the start of the procedure, and repeated if needed. In spite of the drugs, most patients will experience som degree of pain and/or anxiety and increased stress during the procedure. The music therapy intervention contains individually facilitated music listening and coping techniques, aiming to regulate stress responses. The music listening and guidance is provided by a certified music therapist before, during and after the invasive procedure.
Read the detailed description
See study protocol
- Conditions
- C.Surgical Procedure, Stress, Pain, Procedural, Anxiety
- Being tested
- Facilitated Music Listening
- Medical subject headings
- Pain, Procedural, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Facilitated Music ListeningBehavioural
Also called Music therapy
The patient gets a preparatory session with the music therapist one day before the invasive procedure, where individual assessment is made based on a biopsychosocial approach. Sequences of facilitated Music listening is provided during the pre-, peri and postoperative phase, and a closing dialog performed postoperatively. Patient-preferred music is chosen from a limited set of playlists provided on the app The Music Star.
| Study group | Role | What they receive |
|---|---|---|
| Music therapy group | Experimental | Receive Music therapy in addition to standard treatment Receives: Behavioral: Facilitated Music Listening |
| Control group | No intervention | Receive standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction with pain management during the procedure
10-point visual numeric scale, previously used in comparable studies. One represented very dissatisfied and 10 very satisfied
Measured: 1 hour after completion of the procedure
Patient experience of pain intensity during the procedure
Numeric Rating Scale (NRS, 0-10)
Measured: Mean pain intensity during the procedure
Secondary outcomes (3)
Patient experience of anxiety level during the procedure
Numeric Rating Scale (NRS, 0-10)
Measured: Mean anxiety level during the procedure
Effect on vital sign
Mean arterial blood pressure during the procedure
Measured: Mean arterial blood pressure during the procedure
Consumption of analgetic drugs during the procedure
Total need for fentanyl during the procedure, measured in mg
Measured: Total amount of analgesic drug (fentanyl) given throughout the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start1 Mar 2018
- Primary completion27 Sep 2019
- Study completion27 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for C.Surgical ProcedureStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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
- Model description
- Randomized Controlled trial
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Academy of Music
- Responsible party
- Principal investigator, Sigrun Halvorsen, Oslo University Hospital
- Investigators
- Sigrun Halvorsen, Prof. MD PhD, Principal investigator, Ullevaal University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04172662
- Sponsor's protocol ID
- 2018/168
- Acronym
- MATH
- Status last verified
- Nov 2019
- First submitted
- 4 Oct 2019
- Last updated
- 21 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Music Therapy as an Adjunct in Cardiac Implantable Electronic Device (CIED) Lead Extraction Procedures
- ClinicalTrials.gov ID
- NCT04172662
- Acronym / sponsor ID
- MATH / 2018/168
- Conditions
- C.Surgical Procedure, Stress, Pain, Procedural, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Norwegian Academy of Music
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 27 Sep 2019 (actual)
- Study completion
- 27 Sep 2019 (actual)
- First posted
- 21 Nov 2019 (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 study will investigate possible effects of music therapy as an adjunct in an invasive cardiac procedure where infected or broken pacemaker leads, or leads from implantable cardioverter-defibrillators are removed from inside the heart through the vein. The procedure is performed in local anaesthesia with the patient awake. Analgesic and anxiolytic drugs are given at the start of the procedure, and repeated if needed. In spite of the drugs, most patients will experience som degree of pain and/or anxiety and increased stress during the procedure. The music therapy intervention contains individually facilitated music listening and coping techniques, aiming to regulate stress responses. The music listening and guidance is provided by a certified music therapist before, during and after the invasive procedure.
Detailed description
See study protocol
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Controlled trial
| Arm | Type | Receives |
|---|---|---|
| Music therapy group | Experimental | Behavioral: Facilitated Music ListeningReceive Music therapy in addition to standard treatment |
| Control group | No intervention | –Receive standard treatment |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Planned pacemaker or intracardiac defibrillator (ICD) lead extraction performed in local anaesthesia.
- Lead implanted > 12 months ago
- Able to speak and read Norwegian
- Willing to participate All inclusion criteria must be fulfilled.
Key exclusion criteria (3 listed)
- Significant hearing impairment
- Previous and/or acute psychiatric diagnosis
- Cognitive and mental deficits or impaired functioning
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 |
|---|---|---|
| Facilitated Music ListeningAlso: Music therapyThe patient gets a preparatory session with the music therapist one day before the invasive procedure, where individual assessment is made based on a biopsychosocial approach. Sequences of facilitated Music listening is provided during the pre-, peri and postoperative phase, and a closing dialog performed postoperatively. Patient-preferred music is chosen from a limited set of playlists provided on the app The Music Star. | Behavioural | Music therapy group |
Primary outcome
Patient satisfaction with pain management during the procedure
Time frame: 1 hour after completion of the procedure
10-point visual numeric scale, previously used in comparable studies. One represented very dissatisfied and 10 very satisfied
Patient experience of pain intensity during the procedure
Time frame: Mean pain intensity during the procedure
Numeric Rating Scale (NRS, 0-10)
3 secondary outcomes
Patient experience of anxiety level during the procedure
Time frame: Mean anxiety level during the procedure
Effect on vital sign
Time frame: Mean arterial blood pressure during the procedure
Consumption of analgetic drugs during the procedure
Time frame: Total amount of analgesic drug (fentanyl) given throughout the procedure
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 21 Nov 2019.
- Individual participant dataSharing planned: No
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Acute Normovolemic Hemodilution in High Risk Cardiac Surgery Patients.
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Recruiting
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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.
Sigrun Halvorsen, Prof. MD PhD principal investigator
Ullevaal University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Facilitated Music Listening in people with C.Surgical Procedure and Stress, run by Oslo University Hospital at 1 site in Norway.
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 4 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 21 Nov 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 Norway. 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?
Patient satisfaction with pain management during the procedure (time frame: 1 hour after completion of the procedure). The study lists 2 primary outcomes in all. 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 21 Nov 2019.