MusiC to prevent deliriUm during neuroSurgerY

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. We 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 earbuds, 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.

We 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 mention a relative reduction of 36-77%. We will consider the intervention clinical relevant if a relative reduction of 60% with an absolute reduction of 18% is achieved.

T0: inclusion, T1: intervention during admission, T2: 6 weeks follow-up, T3: 3 months follow-up, T4: 6 months follow-up

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 earbuds 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.