Tokyo, Oct. 6 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059291) titled 'Virtual Reality Dental Hypnosis for Reducing Dental Anxiety in Military Patients' on Oct. 5.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Single blind -participants are blinded
Control - Active
Primary Sponsor:
Institute - Padjadjaran University
Condition:
Condition - Dental anxiety (ICD-10 F40.2)
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the effectiveness of Virtual Reality Dental Hypnosis (VRDH) in reducing dental anxiety and modulating brain activity measured by EEG compared with conventional VR distraction.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Group 1 received EEG treatment during a Virtual Reality Distraction Hypnosis (VRDH) session. The session was composed of 7 seconds of hypnotic content and 3 seconds of VR presentation.
Interventions/Control_2 - Group 2 was given a VR intervention with no hypnotic content, but of equal length.
Eligibility:
Age-lower limit - 20
years-old
=
Gender - Male and Female
Key inclusion criteria - 1) Navy soldiers (male or female) who will receive tooth extraction.
2) Aged 20 - 58 years old.
3) Have a tooth that meets the indications for regular extraction in the absence of periodontal abnormalities
4) Have a medium (9-12) or high (13-14) SADT score
5) Willing to be a research subject by signing a letter of consent in the informed consent form.
Key exclusion criteria - 1) Patients with dental phobia (SADT > 25)
2) Female patients who are pregnant, using oral contraceptives and in menstrual cycle
3) Patients using inhaled steroids
4) Patients using any medication that can affect the salivary glands (antihypertensive drugs, antidepressant drugs, antipsychotic drugs)
5) Patients with a history of systemic diseases, endocrine and metabolic diseases and blood deficiencies
6) Patients undergoing corticosteroid and hormonal therapy
7) Patients who have habits that can reduce salivary volume, such as smoking.
8) Patients with xerostomia
9) Patients with drug or alcohol abuse
10) Patients with abnormal psychological development
Target Size - 22
Recruitment Status:
Recruitment status - Terminated
Date of protocol fixation - 2023 Year 04 Month 01 Day
Date of IRB - 2023 Year 04 Month 01 Day
Anticipated trial start date - 2023 Year 04 Month 01 Day
Last follow-up date - 2023 Year 12 Month 01 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067776
Disclaimer: Curated by HT Syndication.