Ignite Creation Date:
2025-12-24 @ 4:55 PM
Ignite Modification Date:
2025-12-28 @ 10:07 AM
Study NCT ID:
NCT04649450
Status:
UNKNOWN
Last Update Posted:
2020-12-02
First Post:
2020-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MusiC to Prevent deliriUm During neuroSurgerY
Sponsor:
Erasmus Medical Center
Organization:
Study Overview
Official Title:
MusiC to Prevent deliriUm During neuroSurgerY: A Single Centered Prospective Randomized Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2020-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MUSYC
Brief 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. 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.
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).
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: