Tokyo, Jan. 25 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060459) titled 'The impact of virtual operating room visits using VR on reducing patient anxiety' on Jan. 25.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Saga University
Condition:
Condition - Not applicable
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Patients preparing for surgery experience a great deal of anxiety and stress before the procedure. In addition to anxiety about the surgery itself, the stress of being in an unfamiliar environment is significant. The aim of this study is to investigate whether it is possible to reduce anxiety and stress by simulating a visit to the operating room using VR prior to surgery.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - VR viewing
Eligibility:
Age-lower limit - 15
years-old
Gender - Male and Female
Key inclusion criteria - Patients admitted to the Department of Oral and Maxillofacial Surgery at Saga University, scheduled for surgery under general anesthesia in the central operating room, and who have given consent to participate in this study.
Key exclusion criteria - (1) Patients under 15 years old or over 80 years old.
(2) Pregnant patients.
(3) Patients with a history of epilepsy.
(4) Patients with claustrophobia.
(5) Patients with a history of mood disorders caused by viewing VR in the past (cyber patients) or patients with vertigo.
(6) Patients with heart disease.
(7) Patients with conditions such as dementia, intellectual disability, post-traumatic stress disorder (PTSD), or psychiatric disorders.
(8) Other patients deemed inappropriate by the investigator.
Target Size - 41
Recruitment Status:
Recruitment status - No longer recruiting
Date of protocol fixation - 2024 Year 11 Month 18 Day
Date of IRB - 2024 Year 11 Month 18 Day
Anticipated trial start date - 2024 Year 11 Month 18 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=R000063811
Disclaimer: Curated by HT Syndication.