MusiC to Prevent deliriUm During neuroSurgerY

  • STATUS
    Recruiting
  • days left to enroll
    31
  • participants needed
    189
  • sponsor
    Erasmus Medical Center
Updated on 26 January 2021

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.

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).

Details
Condition Delirium
Treatment Music
Clinical Study IdentifierNCT04649450
SponsorErasmus Medical Center
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note