Tokyo, Nov. 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059704) titled 'Using Virtual Reality to Help Reduce Anxiety Before Oral Surgery' on Nov. 10.

Study Type: Interventional

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

Primary Sponsor: Institute - Universitas Padjadjaran

Condition: Condition - Preoperative anxiety in oral surgery patients Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The objective of this study is to evaluate the effectiveness of virtual reality in reducing preoperative anxiety among patients undergoing minor oral surgery. This will be assessed using changes in salivary alpha-amylase and cortisol levels, as well as the Amsterdam Preoperative Anxiety and Information Scale (APAIS) Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Virtual Reality Relaxation Participants in the intervention group received a 15-minute immersive Virtual Reality (VR) session immediately prior to minor oral surgery under general anesthesia. The VR content featured a relaxing beach environment with calming background sounds. The session was delivered using a head-mounted display (Oculus Go), with the same video and duration used for all participants to ensure standardization. Duratioin 15 minutes, one-time session Interventions/Control_2 - Standard Preoperative Procedure (Control Group)

Eligibility: Age-lower limit - 18 years-old = Gender - Male and Female Key inclusion criteria - Adults aged 18 to 45 years Scheduled for elective minor oral surgery under general anesthesia Able to understand the study procedures and provide informed consent Able to read and complete the APAIS questionnaire No prior exposure to virtual reality Key exclusion criteria - History of psychiatric or neurological disorders Use of medications affecting stress hormones in the last 7 days (e.g., corticosteroids, anxiolytics) Systemic diseases that may affect saliva biomarkers (e.g., diabetes, adrenal disorders) Current or past substance abuse (alcohol, drugs) Pregnant or breastfeeding Visual, vestibular, or balance disorders that interfere with VR usage Allergy to materials used for saliva collection Unwilling or unable to comply with study procedures Target Size - 30

Recruitment Status: Recruitment status - No longer recruiting Date of protocol fixation - 2024 Year 12 Month 01 Day Date of IRB - 2023 Year 12 Month 15 Day Anticipated trial start date - 2025 Year 01 Month 01 Day Last follow-up date - 2025 Year 07 Month 01 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068285

Disclaimer: Curated by HT Syndication.