Preoperative risk communication in patients scheduled for elective cranial neurosurgery for intracranial space-occupying lesions Surgery
Conditions
Interventions
Before randomization, all 67 patients and/or LARs discussed their conditions with the neurosurgeons and signed the relevant informed consent forms. During this process, 5 patients opted out. Ultimatel
Sponsors
First Affiliated Hospital of Xiamen University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Neurosurgery patients eligible for elective or semi-elective surgery with a feasible standard surgical approach. 2. High-quality Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) Digital Imaging and Communications in Medicine (DICOM) format imaging data from the hospital within 3 days before surgery. If needed, updated imaging must be completed before communication. 3. Eligibility of the communication recipient: The recipient has no visual or auditory impairments, no mental illness, and no cognitive disorders. (i) The patient has the ability to provide informed consent and communicate; (ii) or the patient’s LAR is the primary participant in communication and decision-making (when the patient lacks capacity or has delegated authority). 4. Age and language of the communication recipient: Aged between 18 and 70 years; able to complete questionnaires and tests in Chinese (Mandarin); no gender restriction. 5. Cooperation and compliance: Agree to randomization, complete on-site evaluation, and follow-up before discharge; willing to wear AR display devices when necessary (AR group). 6. Ethical consent: Sign the informed consent related to the study (by the patient or LARs), and allow desensitized use of three-dimensional imaging data for demonstration.
Exclusion criteria
Exclusion criteria: 1. Clinical process-related: 1.1. Emergency surgery patients who cannot be given 24 hours or more for preoperative assessment and communication. 1.2. Patients with severe cognitive or consciousness disorders who are unable to complete the assessment and lack a qualified LARs participant (e.g., persistent delirium, severe aphasia, GCS score = 12: E4+V3+M5 or E2+V5+M5). 1.3. Difficulty cooperating with questionnaires and tests: reading/writing disabilities, inability to complete the tests, and inability to provide equivalent alternative methods (oral expression+researcher recording). 1.4. Recently participated in similar intervention studies or communication-related intervention trials in the past 3 months that may affect primary outcomes (e.g., understanding/decision conflict). 2. Contraindications or high risks related to head-mounted AR devices 2.1. History of photosensitive epilepsy or epilepsy clearly induced by visual stimuli. 2.2. Vestibular dysfunction (frequent dizziness attacks in the last 3 months or daily medication to control symptoms). 2.3. Patients with severe migraines who are highly sensitive to bright light/dynamic images and have frequent episodes recently. 2.4. Severe visual impairments or eye diseases affecting AR device usage (e.g., corrected vision = 0.1, poor control of diplopia, post-ocular surgery recovery period). 2.5. Severe hearing impairments and no equivalent alternative communication methods available on-site (e.g., subtitles/hearing aids). 2.6. Limitations on wearing and positioning: Those unable to safely wear head-mounted AR devices due to external head fixation (e.g., Halo brace), large head dressings, or cervical fixation devices (e.g., neck collar). 2.7. Clear history of adverse reactions to AR devices that led to discontinuation (e.g., severe nausea, balance issues) and the subject’s refusal to attempt again. 3. Others: 3.1. Communication or ethical risks deemed inappropriate for inclusion (e.g., family conflict affecting voluntariness). 3.2. Legal restrictions or special populations requiring extra approval that have not been granted (e.g., populations under compulsory supervision).
Countries
China
Contacts
Public ContactZhanxiang Wang
Outcome results
None listed