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MusiC to Prevent deliriUm During neuroSurgerY

NCT04649450 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 189

Last updated 2020-12-02

No results posted yet for this study

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.

Conditions

  • Delirium

Interventions

OTHER

Music

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.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-09
Primary Completion
2022-07-09
Completion
2023-03-09

Countries

  • Netherlands

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04649450 on ClinicalTrials.gov