Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:55 PM
Ignite Modification Date:
2025-12-24 @ 4:55 PM
NCT ID:
NCT04649450
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04649450
Study Brief:
Protocol Section:
NCT04649450