Tokyo, Aug. 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062576) titled 'Virtual Reality Dental Hypnosis for Dental Anxiety: EEG and Salivary Cortisol Responses' on Aug. 14.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Self control

Primary Sponsor: Institute - Faculty of Dentistry, Universitas Padjadjaran

Condition: Condition - Dental Anxiety During Tooth Extraction Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To investigate short term neurophysiological and neuroendocrine responses following a single session of Virtual Reality Dental Hypnosis (VRDH) in dental patients with moderate dental anxiety undergoing tooth extraction, using electroencephalography (EEG) spectral power and salivary cortisol as objective biomarkers. Basic objectives2 - Others

Intervention: Interventions/Control_1 - Single-arm intervention. Participants receive a standardized Virtual Reality Dental Hypnosis (VRDH) session delivered through a custom virtual reality headset. The intervention consists of a 10-minute prerecorded audiovisual hypnodontic program combining natural landscape scenes and verbal hypnotic suggestions. After completion of the initial session, the audiovisual content is automatically replayed throughout the tooth extraction procedure for approximately 30 minutes. Total VRDH exposure is approximately 40 minutes. EEG is recorded continuously and salivary cortisol is collected before and after the intervention.

Eligibility: Age-lower limit - 20 years-old = Gender - Male and Female Key inclusion criteria - 1. Active-duty Indonesian Navy personnel aged 20 to 58 years. 2. Scheduled to undergo routine tooth extraction. 3. Moderate dental anxiety defined as a Modified Dental Anxiety Scale (MDAS) score of 9 to 14. 4. Presence of teeth indicated for routine extraction without severe periodontal abnormalities. 5. Able and willing to provide written informed consent. Key exclusion criteria - 1. Severe dental phobia. 2. Pregnancy, oral contraceptive use, or menstruation at the time of saliva collection. 3. History of systemic, endocrine, metabolic, hematological, neurological, or psychiatric disorders. 4. Use of corticosteroids, hormonal therapy, inhaled corticosteroids, or medications affecting salivary gland function. 5. Xerostomia. 6. Smoking, alcohol abuse, or substance abuse. 7. Psychological or psychiatric conditions that could interfere with study participation or physiological measurements. Target Size - 11

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2023 Year 03 Month 01 Day Date of IRB - 2023 Year 04 Month 01 Day Anticipated trial start date - 2023 Year 06 Month 01 Day Last follow-up date - 2023 Year 07 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071627

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