Measuring Stress Reduction in Patients Receiving Multimedia Entertainment During Vascular Surgery Under Regional Anesthesia: Protocol for a Randomized Controlled Study
Bibliographic record
Abstract
BACKGROUND: This study explores the treatment of internal carotid artery stenosis in patients with a high risk for cardiovascular events. The use of regional anesthesia permits ongoing neurological monitoring and enhances patient safety during the procedure. However, the operation can be stressful and lengthy, highlighting the need for strategies to alleviate patient discomfort. This study evaluates audiovisual distractions such as video goggles to potentially improve patient experiences during carotid surgeries, a topic that has not yet been comprehensively researched. OBJECTIVE: We aimed to (1) determine whether there is a benefit for patients regarding stress reduction when using video goggles during vascular surgery of the carotid artery and (2) determine whether any parameters can effectively measure such a potential benefit. METHODS: This prospective, randomized study at the University Hospital Augsburg is evaluating the use of HappyMed video goggles by patients undergoing carotid endarterectomy under regional anesthesia. Participants are randomized into either the intervention group, which receives the video goggles, or the control group, which does not. The surgical and anesthetic procedures remain consistent across both groups. Patients are eligible if they meet the surgical criteria, are able to lie supine, and are cooperative. Patients are excluded if they are receiving corticosteroids, have dementia, or have a language barrier. The study uses questionnaires and vital/laboratory parameters, including cortisol levels and heart rate, to assess stress and anxiety. To monitor potential motion sickness, the occurrence of nausea or vomiting is documented. Both patients and surgical staff will evaluate the experience postoperatively to determine the goggles' impact on patient experience and stress management during surgery. RESULTS: The study has been approved by the local ethics committee and is registered at ClinicalTrials.gov. Patient inclusion started in September 2022 and should be completed within 3 to 4 years. This paper presents a study protocol that was finalized and approved by the local ethics committee in September 2022. At the time of this protocol's final submission for publication, approximately 90% of the recruitment had been completed. Following completion of recruitment and data acquisition, the results are intended to be published within one year. CONCLUSIONS: This study aims to improve patient comfort and perioperative care during vascular surgery. Therefore, our study aims to investigate if the use of video goggles during surgery is feasible and if there are parameters that indicate a benefit for patients. This study is being conducted as a pilot trial to provide a foundation for future research aimed at improving patient comfort during carotid artery surgery under local anesthesia. TRIAL REGISTRATION: ClinicalTrials.gov NCT06704230; https://clinicaltrials.gov/study/NCT06704230. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/70597.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.028 | 0.026 |
| Meta-epidemiology (narrow) | 0.005 | 0.002 |
| Meta-epidemiology (broad) | 0.011 | 0.005 |
| Bibliometrics | 0.003 | 0.004 |
| Science and technology studies | 0.004 | 0.003 |
| Scholarly communication | 0.003 | 0.002 |
| Open science | 0.003 | 0.002 |
| Research integrity | 0.007 | 0.007 |
| Insufficient payload (model declined to judge) | 0.046 | 0.007 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".