Tokyo, Sept. 7 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062814) titled 'A Study on Whether Watching an Explanatory Video Before Knee Replacement Surgery Reduces Anxiety and Improves Understanding' on Sept. 7.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - Zenshukai Hospital

Condition: Condition - knee osteoarthritis Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - Total knee arthroplasty (TKA) for knee osteoarthritis is increasing with population aging. However, about 20% of patients report dissatisfaction after surgery, attributed largely to the gap between preoperative expectations and actual outcomes. Providing appropriate preoperative information and aligning patients' understanding and expectations with reality is therefore key to improving satisfaction.

Patients undergoing TKA are prone to anxiety about postoperative pain and functional recovery, yet how much insufficient preoperative information and anxiety affect satisfaction remains unclear. Studies using the Amsterdam Preoperative Anxiety and Information Scale (APAIS) have shown a strong correlation between preoperative information requirement and anxiety, and APAIS has also been used to evaluate nurse-led patient education in TKA. Appropriate perioperative education is an important nursing role.

At our institution, preoperative explanation is given mainly verbally, and patients often express uncertainty about what they do not understand, suggesting that tension and anxiety may prevent adequate comprehension. Video-based preoperative orientation reportedly helps patients visualize the perioperative course, but evidence on how much it improves information needs and anxiety, and how this affects satisfaction, is limited. Advances in large language models (LLM) now allow staff without specialized skills to produce patient education material, but no study has examined the effect of a preoperative explanation video created using an LLM.

This study therefore aims to determine whether introducing an institution-produced, repeatedly viewable preoperative explanation video created using an LLM, covering the surgical procedure, postoperative rehabilitation, and pre- and postoperative precautions, improves comprehension, preoperative anxiety, and postoperative satisfaction in elderly patients undergoing TKA. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Standard preoperative explanation given verbally by physicians and nurses in accordance with the institution's usual practice, delivered at the preoperative examination visit. Interventions/Control_2 - The same standard verbal explanation, plus a preoperative explanation video (approximately 10 minutes) produced by our institution and supervised by our orthopedic surgeons. At the time surgery is scheduled, patients receive a printed sheet with a QR code linking to the video, which can be viewed repeatedly on the patient's own smartphone or similar device. Patients unable to view the video by themselves watch it in the outpatient clinic on the day of the preoperative examination.

Eligibility: Age-lower limit - 65 years-old = Gender - Male and Female Key inclusion criteria - Patients undergoing total knee arthroplasty for the first time at our institution, aged 65 to 89 years, who provide written informed consent. Key exclusion criteria - 1.Patients who are unable to complete the questionnaires. 2.Patients undergoing simultaneous bilateral TKA. 3.Patients who cannot follow the standard perioperative schedule because of comorbidities or complications unrelated to the surgery itself. Target Size - 140

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2026 Year 09 Month 02 Day Date of IRB - 2026 Year 09 Month 02 Day Anticipated trial start date - 2026 Year 09 Month 14 Day Last follow-up date - 2028 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071907

Disclaimer: Curated by HT Syndication.