Clinical trial NCT04649450: MusiC to Prevent deliriUm During neuroSurgerY
Official title: MusiC to Prevent deliriUm During neuroSurgerY: A Single Centered Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Delirium
Keywords: Neurosurgery
Delirium
Music
Randomized Controlled Trial
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2020-12-02
Enrollment: 189
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomly allocated to either the intervention (music) or control (standard care) group.
Primary purpose: PREVENTION

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.

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).

Eligibility criteria: Inclusion Criteria:

1. Patients undergoing a craniotomy.
2. Adult patients (cq age ≥18 years)
3. Sufficient knowledge of the Dutch language to understand the study documents in the judgement of the attending physician or researcher.
4. Provision of written informed consent by patient or legal representative.

Exclusion Criteria:

1. Impaired awareness before surgery (i.e. GCS \< M6).
2. Planned post-operative ICU admission.
3. Suspected delirium (defined as fluctuating awareness).
4. Current antipsychotic treatment
5. Patients undergoing interventions impeding supply of music (e.g. surgical translabyrinthine approach, awake surgery).
6. Severe bilateral hearing impairment, defined as no verbal communication possible.
7. Current participation in other clinical trials interfering with results.

Primary outcomes:
measure: Delirium
timeFrame: 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:
measure: Severity and duration of delirium.
timeFrame: First five days or discharge. In case of positive delirium until it has 'faded out'.
Other outcomes:
measure: Pre-operative anxiety.
timeFrame: Day before surgery only
measure: Activation of the parasympathetic nervous system.
timeFrame: The day of surgery (day 0) before and after surgery
measure: Depth of anesthesia with Bispectral Index.
timeFrame: During surgery
measure: Peri-operative medication.
timeFrame: During admission.
measure: Postoperative pain.
timeFrame: Post-operative day 1 - 3
measure: Patients with postoperative complications.
timeFrame: Within two weeks after surgery.
measure: Hospital length of stay.
timeFrame: From baseline until discharge in the same admission having received the intervention.
measure: Cognitive function.
timeFrame: Baseline, 3 months and 6 months after surgery.
measure: Patient functional outcome.
timeFrame: Baseline, 6 weeks, 3 months and 6 months.
measure: Patient functional outcome.
timeFrame: Baseline, 6 weeks, 3 months and 6 months.
measure: Mortality and readmission rate.
timeFrame: Follow up until 6 months.
measure: Patient reported outcome.
timeFrame: Baseline, 6 weeks, 3 months and 6 months after surgery.
measure: Patient reported outcome.
timeFrame: Baseline, 6 weeks, 3 months and 6 months after surgery.
measure: Patient reported outcome.
timeFrame: Baseline, 6 weeks, 3 months and 6 months after surgery.
measure: Patient satisfaction.
timeFrame: Follow-up 6 weeks
measure: Economic evaluation.
timeFrame: Follow-up at 3 and 6 months
Locations:
city: Rotterdam
country: Netherlands
facility: ErasmusMC
state: Zuid-Holland
Study officials:
References:
citation: Kappen 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.