MusiC to Prevent deliriUm During neuroSurgerY

NCT04649450 | Unknown

• 1 other identifier: MEC-2020-0064
• Study Type: interventional
• Target: 189
• Locations: 1 country
• Sites: 1

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.

Conditions

Delirium

Keywords

Neurosurgery; Delirium; Music; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Delirium

  All participating patients on the ward will be screened using the Delirium Observation Screening (DOS) scale. The DOS is a score of 1 until 13, in which a score of 3 or higher is suspicious for delirium. Screening is conducted 3 times per day (i.e. during each shift) and maintained until day 5. In case of raised suspicion of delirium by DOS, a psychiatrist is consulted to confirm or reject clinical diagnosis of delirium based on the DSM-V criteria. Presence of delirium is confirmed by the psychiatrist after positive DOS screening, all other patients will be considered as absence of delirium. In case of discharge towards another hospital within 5 days, onset of delirium is evaluated in that hospital. In case of discharge within 5 days towards home without delirium, it will be considered as no delirium.

  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 (1)

• Severity and duration of delirium.

  First five days or discharge. In case of positive delirium until it has 'faded out'.

Other Outcomes (16)

• Pre-operative anxiety.

  Day before surgery only

• Activation of the parasympathetic nervous system.

  The day of surgery (day 0) before and after surgery

• Depth of anesthesia with Bispectral Index.

  During surgery

Study Arms (2)

Music

EXPERIMENTAL

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 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 (post-operative day 1, 2 and 3) at the neurosurgical ward they will receive music twice a day for 30 minutes. All participants will further receive standard of clinical care.

Other: Music

Standard of clinical care

NO INTERVENTION

Standard of clinical care.

Interventions

Music OTHER

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.

Music

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

ErasmusMC

Rotterdam, South Holland, 3015 GD, Netherlands

RECRUITING

Related Publications (3)

• Dirven TLA, Kappen PR, van der Beek FTH, van der Holt B, Jeekel H, Dirven CMF, Vincent AJPE, Klimek M, Poley MJ. The effect of music interventions compared to standard-of-care on the prevention of delirium in neurosurgical patients: an analysis of costs and cost-effectiveness based on the MUSYC-trial. Acta Neurochir (Wien). 2025 Feb 14;167(1):46. doi: 10.1007/s00701-025-06448-0.

  PMID: 39951210 DERIVED

• Kappen PR, Mos MI, Jeekel J, Dirven CMF, Kushner SA, Osse RJ, Coesmans M, Poley MJ, van Schie MS, van der Holt B, Klimek M, Vincent AJPE. Music to prevent deliriUm during neuroSurgerY (MUSYC): a single-centre, prospective randomised controlled trial. BMJ Open. 2023 Jun 27;13(6):e069957. doi: 10.1136/bmjopen-2022-069957.

  PMID: 37369412 DERIVED

• 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.

  PMID: 34598983 DERIVED

MeSH Terms

Conditions

Delirium

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Pablo R Kappen, MD

CONTACT

+31617226531; p.kappen@erasmusmc.nl

A. Vincent, MD PHD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Music vs. standard clinical care. No blinding of treatment was conducted.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Patients will be randomly allocated to either the intervention (music) or control (standard care) group.

Study Record Dates

• First Submitted: September 11, 2020
• First Posted: December 2, 2020
• Study Start: July 9, 2020
• Primary Completion: July 9, 2022
• Study Completion: March 9, 2023
• Last Updated: December 2, 2020

Record last verified: 2020-11

Locations

NL (1)