DeliriumMUSYCNCT04649450
MusiC to Prevent deliriUm During neuroSurgerY
A study testing Music in people with Delirium, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
Rationale: Delirium is a common and severe complication after neurosurgical procedures. Music before, during and after surgical procedures has proven its effectiveness in reducing pain, anxiety, stress and opioid medication in surgical patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delirium
- What is being tested?
- Music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 189 participants
- Where
- 1 siteNetherlands
- Study dates
- 9 Jul 2020to 9 Mar 2023
- 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
- Patients undergoing a craniotomy.
- Adult patients (cq age ≥18 years)
- Sufficient knowledge of the Dutch language to understand the study documents in the judgement of the attending physician or researcher.
- Provision of written informed consent by patient or legal representative.
Who cannot join
- Impaired awareness before surgery (i.e. GCS < M6).
- Planned post-operative ICU admission.
- Suspected delirium (defined as fluctuating awareness).
- Current antipsychotic treatment
- Patients undergoing interventions impeding supply of music (e.g. surgical translabyrinthine approach, awake surgery).
- Severe bilateral hearing impairment, defined as no verbal communication possible.
- Current participation in other clinical trials interfering with results.
Trial locations and contacts
1 site in 1 country.
A. Vincent, MD PHD contact
Netherlands1 site, 1 recruiting
- Recruiting
ErasmusMC
Rotterdam, South Holland, 3015 GD
Pablo R Kappen, MD, +31617226531, p.kappen@erasmusmc.nl
A. Vincent, MD PHD
About this study
Official title: MusiC to Prevent deliriUm During neuroSurgerY: A Single Centered Prospective Randomized Controlled Trial
Rationale: Delirium is a common and severe complication after neurosurgical procedures. Music before, during and after surgical procedures has proven its effectiveness in reducing pain, anxiety, stress and opioid medication in surgical patients. These symptoms belong to the main eliciting factors for developing delirium. Effective preventive therapy for delirium is not available. The investigators hypothesize that music listening, being a sustainable intervention with negligible risk of side effects, can lower delirium incidence among neurosurgical patients, resulting in reduction of in-hospital stays, healthcare costs and post-operative morbidity and mortality.
Objective: To assess the effect of peri-operative music on post-operative delirium in patients undergoing a craniotomy.
Read more
Study design: Single-centre prospective randomized controlled trial.
Study population: Adult patients undergoing a craniotomy at the Erasmus MC in Rotterdam.
Intervention: Recorded music, with headphones or earphones, before, during and after surgery.
Main study parameters/endpoints: Diagnosis of post-operative delirium screened by the DOS score confirmed by the consultant psychiatrist following the DSM-V criteria.
Read the detailed description
Rationale:
Delirium is a common and severe complication after neurosurgical procedures. Music before, during and after surgical procedures has proven its effectiveness in reducing pain, anxiety, stress and opioid medication in surgical patients. These symptoms belong to the main eliciting factors for developing delirium. Effective preventive therapy for delirium is not available. The investigators hypothesize that music listening, being a sustainable intervention with negligible risk of side effects, can lower delirium incidence among neurosurgical patients, resulting in reduction of in-hospital stays, healthcare costs and post-operative morbidity and mortality.
Objective:
To assess the effect of peri-operative music on post-operative delirium in patients undergoing a craniotomy.
Hypothesis effect and sample size:
The investigators expect an incidence of delirium in our control group of 30%. This is based on literature documenting incidence of delirium in neurosurgical patients in a northern European population of 29-33%.The expected effect cannot be based on previous literature since no adequate trials exist on the effect of music on delirium. Other non-pharmacological interventions in delirium prevention mention a relative reduction of 36-77%. The investigators will consider the intervention clinical relevant if a relative reduction of 60% with an absolute reduction of 18% is achieved. Taking into account the incidence of delirium of 30%, a power of 80%, a two-sided significant p-value of <0,05 in a 1:1 randomization leads to a sample size of 90 patients per arm. The investigators expect a loss to follow-up of 5% and will therefore include 189 patients.
Interventions:
Patients will be randomly allocated to either the intervention (music) or control (standard care) group. Participants in the music group will receive headphones with music 30 minutes before surgery. Patients will be able to choose music from a preselected list composed by a team consisting of researchers and dedicated music therapists. The headphones will be removed just before entering the operating room. Once in the operating room they will receive earphones after intubation, compatible with the Mayfield and site of operation. The intraoperative music intervention will be continued during the surgical procedure and discontinued just before detubation. The duration of the intraoperative music intervention depends on the duration of surgery and will be documented. After surgery, during recovery at the post-operative care unit (PACU) another 30 minutes of music through headphones will be given. The following 3 days at the neurosurgical ward they will receive music twice per day for 30 minutes.
Primary outcome: The primary outcome measure is presence or absence of postoperative delirium within the first 5 days after surgery. All participating patients on the ward will be screened using the Delirium Observation Screening (DOS) scale. Additional to the DOS, in case of raised suspicion of delirium, a psychiatrist is consulted to confirm or reject clinical diagnosis of delirium based on the DSM-V criteria.
Secondary outcome:
- Severity and duration of delirium (DRS-R-98)
- Pre-operative anxiety (VAS-A)
- Activation of the parasympathetic nervous system measured with HRV.
- Depth of anaesthesia registered with Bispectral Index (BIS).
- Peri-operative medication use.
- Postoperative pain (NRS).
- Patients with postoperative complications (AE/SAE's).
- Hospital length of stay (days).
- Cognitive function (MoCA).
- Patient functional outcome (KPS).
- Patient functional outcome (mRS).
- Mortality and readmission rate.
- Patient-reported outcome (EORTC-QLQ-C30)
- Patient-reported outcome (EORTC-QLQ-BN20)
- Patient-reported outcome (EQ-5D).
- Patient satisfaction (VAS).
- Economic evaluation / cost-effectiveness (iPCQ).
- Conditions
- Delirium
- Being tested
- Music
- Keywords
- Neurosurgery, Delirium, Music, Randomized Controlled Trial
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MusicOther
Participants in the music group will receive headphones with music 30 minutes before surgery. Patients will be able to choose music from a preselected list composed by a team consisting of researchers and dedicated music therapists. The headphones will be removed just before entering the operating room. Once in the operating room they will receive earphones after intubation, compatible with the Mayfield and site of operation. The intraoperative music intervention will be continued during the surgical procedure and discontinued just before detubation. The duration of the intraoperative music intervention depends on the duration of surgery and will be documented. After surgery, during recovery at the post-operative care unit (PACU) another 30 minutes of music through headphones will be given. The following 3 days at the neurosurgical ward they will receive music twice a day for 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Music | Experimental | Participants in the music group will receive headphones with music 30 minutes before surgery. Patients will be able to choose music from a preselected list composed by a team consisting of researchers and dedicated music therapists. The headphones will be removed before entering the operating room. Once in the operating room they will receive earphones after intubation, compatible with the Mayfield and site of operation. The intraoperative music intervention will be continued during the surgical procedure and discontinued just before detubation. The duration of the intraoperative music intervention depends on the duration of surgery and will be documented. After surgery, during recovery at the post-operative care unit (PACU) another 30 minutes of music through headphones will be given. The following 3 days (post-operative day 1, 2 and 3) at the neurosurgical ward they will receive music twice a day for 30 minutes. All participants will further receive standard of clinical care. Receives: Other: Music |
| Standard of clinical care | No intervention | Standard of clinical care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delirium
All participating patients on the ward will be screened using the Delirium Observation Screening (DOS) scale. The DOS is a score of 1 until 13, in which a score of 3 or higher is suspicious for delirium. Screening is conducted 3 times per day (i.e. during each shift) and maintained until day 5. In case of raised suspicion of delirium by DOS, a psychiatrist is consulted to confirm or reject clinical diagnosis of delirium based on the DSM-V criteria. Presence of delirium is confirmed by the psychiatrist after positive DOS screening, all other patients will be considered as absence of delirium. In case of discharge towards another hospital within 5 days, onset of delirium is evaluated in that hospital. In case of discharge within 5 days towards home without delirium, it will be considered as no delirium.
Measured: First five post-operative days. In case of discharge within 5 days towards home without delirium, it will be considered as no delirium.
Secondary outcomes (1)
Severity and duration of delirium.
In case of positive delirium, its severity will be assessed using the Delirium Rating Scale-revised-98 (DRS-R-98). DSR-98 regards a 13-item score sheet in which 0 represents the lowest and 39 represents the highest severity. It will be assessed by the consultant psychiatrist on the day of onset of delirium. Subsequently, as long as the delirium lasts the severity is assessed once every three days (i.e. Monday, Wednesday and Friday). To assess duration of delirium, the DOS score will be used; a DOS <3 during 24 hours will be considered as a 'faded out' delirium and number of days from onset until end will be documented.
Measured: First five days or discharge. In case of positive delirium until it has 'faded out'.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study start9 Jul 2020
- Primary completion9 Jul 2022 (estimated)
- Study completion9 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomly allocated to either the intervention (music) or control (standard care) group.
- Masking
- None (open label)
- Enrolment
- 189 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, A.J.P.E. VIncent, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04649450
- Sponsor's protocol ID
- MEC-2020-0064
- Acronym
- MUSYC
- Status last verified
- Nov 2020
- First submitted
- 11 Sep 2020
- Last updated
- 2 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dirven TLA, Kappen PR, van der Beek FTH, van der Holt B, Jeekel H, Dirven CMF, Vincent AJPE, Klimek M, Poley MJ. The effect of music interventions compared to standard-of-care on the prevention of delirium in neurosurgical patients: an analysis of costs and cost-effectiveness based on the MUSYC-trial. Acta Neurochir (Wien). 2025 Feb 14;167(1):46. doi: 10.1007/s00701-025-06448-0.
PubMed 39951210Kappen PR, Mos MI, Jeekel J, Dirven CMF, Kushner SA, Osse RJ, Coesmans M, Poley MJ, van Schie MS, van der Holt B, Klimek M, Vincent AJPE. Music to prevent deliriUm during neuroSurgerY (MUSYC): a single-centre, prospective randomised controlled trial. BMJ Open. 2023 Jun 27;13(6):e069957. doi: 10.1136/bmjopen-2022-069957.
PubMed 37369412Kappen P, Jeekel J, Dirven CMF, Klimek M, Kushner SA, Osse RJ, Coesmans M, Poley MJ, Vincent AJPE. Music to prevent deliriUm during neuroSurgerY (MUSYC) Clinical trial: a study protocol for a randomised controlled trial. BMJ Open. 2021 Oct 1;11(10):e048270. doi: 10.1136/bmjopen-2020-048270.
PubMed 34598983
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MusiC to Prevent deliriUm During neuroSurgerY: A Single Centered Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04649450
- Acronym / sponsor ID
- MUSYC / MEC-2020-0064
- Conditions
- Delirium
- Keywords
- Neurosurgery, Delirium, Music, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 189 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 9 Jul 2020 (actual)
- Primary completion
- 9 Jul 2022 (estimated)
- Study completion
- 9 Mar 2023 (estimated)
- First posted
- 2 Dec 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.
Rationale: Delirium is a common and severe complication after neurosurgical procedures. Music before, during and after surgical procedures has proven its effectiveness in reducing pain, anxiety, stress and opioid medication in surgical patients. These symptoms belong to the main eliciting factors for developing delirium. Effective preventive therapy for delirium is not available. The investigators hypothesize that music listening, being a sustainable intervention with negligible risk of side effects, can lower delirium incidence among neurosurgical patients, resulting in reduction of in-hospital stays, healthcare costs and post-operative morbidity and mortality.
Objective: To assess the effect of peri-operative music on post-operative delirium in patients undergoing a craniotomy.
Study design: Single-centre prospective randomized controlled trial.
Study population: Adult patients undergoing a craniotomy at the Erasmus MC in Rotterdam.
Intervention: Recorded music, with headphones or earphones, before, during and after surgery.
Main study parameters/endpoints: Diagnosis of post-operative delirium screened by the DOS score confirmed by the consultant psychiatrist following the DSM-V criteria.
Detailed description
Rationale:
Delirium is a common and severe complication after neurosurgical procedures. Music before, during and after surgical procedures has proven its effectiveness in reducing pain, anxiety, stress and opioid medication in surgical patients. These symptoms belong to the main eliciting factors for developing delirium. Effective preventive therapy for delirium is not available. The investigators hypothesize that music listening, being a sustainable intervention with negligible risk of side effects, can lower delirium incidence among neurosurgical patients, resulting in reduction of in-hospital stays, healthcare costs and post-operative morbidity and mortality.
Objective:
To assess the effect of peri-operative music on post-operative delirium in patients undergoing a craniotomy.
Hypothesis effect and sample size:
The investigators expect an incidence of delirium in our control group of 30%. This is based on literature documenting incidence of delirium in neurosurgical patients in a northern European population of 29-33%.The expected effect cannot be based on previous literature since no adequate trials exist on the effect of music on delirium. Other non-pharmacological interventions in delirium prevention mention a relative reduction of 36-77%. The investigators will consider the intervention clinical relevant if a relative reduction of 60% with an absolute reduction of 18% is achieved. Taking into account the incidence of delirium of 30%, a power of 80%, a two-sided significant p-value of <0,05 in a 1:1 randomization leads to a sample size of 90 patients per arm. The investigators expect a loss to follow-up of 5% and will therefore include 189 patients.
Interventions:
Patients will be randomly allocated to either the intervention (music) or control (standard care) group. Participants in the music group will receive headphones with music 30 minutes before surgery. Patients will be able to choose music from a preselected list composed by a team consisting of researchers and dedicated music therapists. The headphones will be removed just before entering the operating room. Once in the operating room they will receive earphones after intubation, compatible with the Mayfield and site of operation. The intraoperative music intervention will be continued during the surgical procedure and discontinued just before detubation. The duration of the intraoperative music intervention depends on the duration of surgery and will be documented. After surgery, during recovery at the post-operative care unit (PACU) another 30 minutes of music through headphones will be given. The following 3 days at the neurosurgical ward they will receive music twice per day for 30 minutes.
Primary outcome: The primary outcome measure is presence or absence of postoperative delirium within the first 5 days after surgery. All participating patients on the ward will be screened using the Delirium Observation Screening (DOS) scale. Additional to the DOS, in case of raised suspicion of delirium, a psychiatrist is consulted to confirm or reject clinical diagnosis of delirium based on the DSM-V criteria.
Secondary outcome:
- Severity and duration of delirium (DRS-R-98)
- Pre-operative anxiety (VAS-A)
- Activation of the parasympathetic nervous system measured with HRV.
- Depth of anaesthesia registered with Bispectral Index (BIS).
- Peri-operative medication use.
- Postoperative pain (NRS).
- Patients with postoperative complications (AE/SAE's).
- Hospital length of stay (days).
- Cognitive function (MoCA).
- Patient functional outcome (KPS).
- Patient functional outcome (mRS).
- Mortality and readmission rate.
- Patient-reported outcome (EORTC-QLQ-C30)
- Patient-reported outcome (EORTC-QLQ-BN20)
- Patient-reported outcome (EQ-5D).
- Patient satisfaction (VAS).
- Economic evaluation / cost-effectiveness (iPCQ).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be randomly allocated to either the intervention (music) or control (standard care) group.
| Arm | Type | Receives |
|---|---|---|
| Music | Experimental | Other: MusicParticipants in the music group will receive headphones with music 30 minutes before surgery. Patients will be able to choose music from a preselected list composed by a team consisting of researchers and dedicated music therapists. The headphones will be removed before entering the operating room. Once in the operating room they will receive earphones after intubation, compatible with the Mayfield and site of operation. The intraoperative music intervention will be continued during the surgical procedure and discontinued just before detubation. The duration of the intraoperative music intervention depends on the duration of surgery and will be documented. After surgery, during recovery at the post-operative care unit (PACU) another 30 minutes of music through headphones will be given. The following 3 days (post-operative day 1, 2 and 3) at the neurosurgical ward they will receive music twice a day for 30 minutes. All participants will further receive standard of clinical care. |
| Standard of clinical care | No intervention | –Standard of clinical care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients undergoing a craniotomy.
- Adult patients (cq age ≥18 years)
- Sufficient knowledge of the Dutch language to understand the study documents in the judgement of the attending physician or researcher.
- Provision of written informed consent by patient or legal representative.
Key exclusion criteria (7 listed)
- Impaired awareness before surgery (i.e. GCS < M6).
- Planned post-operative ICU admission.
- Suspected delirium (defined as fluctuating awareness).
- Current antipsychotic treatment
- Patients undergoing interventions impeding supply of music (e.g. surgical translabyrinthine approach, awake surgery).
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 |
|---|---|---|
| MusicParticipants in the music group will receive headphones with music 30 minutes before surgery. Patients will be able to choose music from a preselected list composed by a team consisting of researchers and dedicated music therapists. The headphones will be removed just before entering the operating room. Once in the operating room they will receive earphones after intubation, compatible with the Mayfield and site of operation. The intraoperative music intervention will be continued during the surgical procedure and discontinued just before detubation. The duration of the intraoperative music intervention depends on the duration of surgery and will be documented. After surgery, during recovery at the post-operative care unit (PACU) another 30 minutes of music through headphones will be given. The following 3 days at the neurosurgical ward they will receive music twice a day for 30 minutes. | Other | Music |
Primary outcome
Delirium
Time frame: First five post-operative days. In case of discharge within 5 days towards home without delirium, it will be considered as no delirium.
All participating patients on the ward will be screened using the Delirium Observation Screening (DOS) scale. The DOS is a score of 1 until 13, in which a score of 3 or higher is suspicious for delirium. Screening is conducted 3 times per day (i.e. during each shift) and maintained until day 5. In case of raised suspicion of delirium by DOS, a psychiatrist is consulted to confirm or reject clinical diagnosis of delirium based on the DSM-V criteria. Presence of delirium is confirmed by the psychiatrist after positive DOS screening, all other patients will be considered as absence of delirium. In case of discharge towards another hospital within 5 days, onset of delirium is evaluated in that hospital. In case of discharge within 5 days towards home without delirium, it will be considered as no delirium.
1 secondary outcome
Severity and duration of delirium.
Time frame: First five days or discharge. In case of positive delirium until it has 'faded out'.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2020.
- Derived from this study: PubMed 39951210Dirven TLA, Kappen PR, van der Beek FTH, van der Holt B, Jeekel H, Dirven CMF, Vincent AJPE, Klimek M, Poley MJ. The effect of music interventions compared to standard-of-care on the prevention of delirium in neurosurgical patients: an analysis of costs and cost-effectiveness based on the MUSYC-trial. Acta Neurochir (Wien). 2025 Feb 14;167(1):46. doi: 10.1007/s00701-025-06448-0.
- Derived from this study: PubMed 37369412Kappen PR, Mos MI, Jeekel J, Dirven CMF, Kushner SA, Osse RJ, Coesmans M, Poley MJ, van Schie MS, van der Holt B, Klimek M, Vincent AJPE. Music to prevent deliriUm during neuroSurgerY (MUSYC): a single-centre, prospective randomised controlled trial. BMJ Open. 2023 Jun 27;13(6):e069957. doi: 10.1136/bmjopen-2022-069957.
- Derived from this study: PubMed 34598983Kappen P, Jeekel J, Dirven CMF, Klimek M, Kushner SA, Osse RJ, Coesmans M, Poley MJ, Vincent AJPE. Music to prevent deliriUm during neuroSurgerY (MUSYC) Clinical trial: a study protocol for a randomised controlled trial. BMJ Open. 2021 Oct 1;11(10):e048270. doi: 10.1136/bmjopen-2020-048270.
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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.
A. Vincent, MD PHD contact
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 in people with Delirium, run by Erasmus Medical Center at 1 site in Netherlands.
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 7 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 2 Dec 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 Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pablo R Kappen, MD (+31617226531, p.kappen@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delirium (time frame: First five post-operative days. In case of discharge within 5 days towards home without delirium, it will be considered as no delirium.). 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 NCT04649450, which also lists 3 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 2 Dec 2020.