Comparing augmented reality glasses with a physical brain model to help patients and families understand the risks of planned brain surgery
| ISRCTN | ISRCTN11483487 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11483487 |
| Sponsor | First Affiliated Hospital of Xiamen University |
| Funder | First Affiliated Hospital of Xiamen University |
- Submission date
- 16/01/2026
- Registration date
- 13/02/2026
- Last edited
- 12/02/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Zhanxiang Wang
Public, Principal investigator
Public, Principal investigator
The First Affiliated Hospital of Xiamen University
School of Medicine
Xiamen University
No. 55 Zhenhai Road
Siming District
Xiamen
361001
China
 ORCID ID |
0000-0003-0405-6194 |
|---|---|
| Phone | +86 (0)15587331975 |
| WangZX@xmu.edu.cn |
Dr Zhengbo Yuan
Scientific
Scientific
The First Affiliated Hospital of Xiamen University
School of Medicine
Xiamen University
No. 55 Zhenhai Road, Siming District
Xiamen
361001
China
| ORCID ID |
0000-0002-9337-9544 |
|---|---|
| Phone | +86 (0)15154608303 |
| 24520240157824@stu.xmu.edu.cn |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Randomized controlled trial |
| Masking | Open (masking not used) |
| Control | Active |
| Assignment | Parallel |
| Purpose | Device feasibility |
| Scientific title | Comparing augmented reality glasses with a physical brain model to help patients and families understand the risks of planned brain surgery |
| Study objectives | To determine whether head-mounted augmented reality visualization using individualized three-dimensional models during routine preoperative counseling improves objective and self-reported understanding of surgical risks in patients (and/or legally authorized representatives) scheduled for elective cranial neurosurgery for intracranial space-occupying lesions, compared with counseling aided by a physical anatomical model. Secondary objectives are to compare post-counseling anxiety, communication satisfaction, consultation duration, and clinician communication performance assessed using the SEGUE framework based on video-recorded consultations. |
| Ethics approval(s) |
Approved 13/11/2025, Ethics Committee of the First Affiliated Hospital of Xiamen University (No. 55 Zhenhai Road, Siming District, Xiamen, 361003, China; +86 (0)592-2132222, +86 (0)15154608303; 1125073977@qq.com), ref: XMYY-2025KYSB353 |
| Health condition(s) or problem(s) studied | Preoperative risk communication in patients scheduled for elective cranial neurosurgery for intracranial space-occupying lesions |
| Intervention | 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. Ultimately, the 62 communication participants who engaged in the communication all completed the State-Trait Anxiety Inventory (STAI-Form Y-Chinese Version, https://scales.arabpsychology.com/Ch/state-trait-anxiety-inventory-stai-form-y-chinese-version/), which was used to evaluate the participants' state anxiety (State Anxiety Inventory, STAI Y-1) and trait anxiety (Trait Anxiety Inventory, STAI Y-2), with higher scores indicating higher levels of anxiety. To evaluate the comprehension abilities of the communication participants, the researchers assessed their cognitive function using the Montreal Cognitive Assessment (MOCA, Chinese 7.1-Beijing) (https://mocacognition.com). Randomization was then performed within three strata. In the experimental group (AR group), the communication participants wore the SeerLens® AR device when necessary, and the doctor superimposed the digital 3D model presented by the AR device onto the patient's real head, showing the corresponding spatial structures based on the patient’s actual lesion location and explaining them to the communication participant. In the control group (physical model group), the doctor provided explanations to the communication participant with the assistance of a physical anatomical model. After the communication, the doctor will perform another evaluation of the communication recipient. This evaluation includes: (1) A medical knowledge comprehension questionnaire: (i) A subjective understanding rating scale (Cronbach's α=0.88) (Supplementary file 2) to assess subjective comprehension. (ii) An objective comprehension assessment (Supplementary file 3): Evaluated using directed multiple-choice questions, which cover the patient’s current diagnosis, initial treatment plan, tumor location, surgical method, intraoperative adverse events, and complications. (2) Anxiety assessment (STAI-Form Y Chinese Version: STAI Y-1 and STAI Y-2). (3) A self-developed communication satisfaction rating scale (Cronbach's α=0.86) (Supplementary file 4). The entire communication process is timed by the physician conducting the conversation. The entire communication process is video recorded for subsequent independent researchers to use the SEGUE scale (Chinese version, https://m.medsci.cn/scale/show.do?id=50cc362ee3)to independently assess the communication skills of the physician. |
| Intervention type | Supplement |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
|
| Completion date | 30/09/2025 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | All |
| Target sample size at registration | 70 |
| Total final enrolment | 62 |
| Key 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. |
| Key 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). |
| Date of first enrolment | 06/01/2025 |
| Date of final enrolment | 08/09/2025 |
Locations
Countries of recruitment
- China
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
Editorial Notes
19/01/2026: Study's existence confirmed by the Ethics Committee of the First Affiliated Hospital of Xiamen University
