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IRCT20230219057451N1 IRCT 2023-02-21 Diponegoro University Effects of Immersive Virtual Reality on patient anxiety during surgery : A randomized clinical trial Effects of Immersive Virtual Reality on patient anxiety during surgery under regional anesthesia: A randomized clinical trial 2021-10-14 anticipated 30 Complete https://irct.ir/trial/68651 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Method of randomization that we used was simple random sampling procedure. The randomization process was performed using numbers randomized by an internet-based computer program (www.randomization.com). The numbers were placed in a sealed envelope. The sealed envelope was opened when the patient arrived at the pre-operation room; then, the patient asked to take one of the papers containing a number. The intervention was given to the subjects selected through randomization based on number in the sealed envelope. Odd numbers were the intervention group, even numbers were the control group, Blinding description: This was single blind clinical trial. The surgeons who reported their satisfaction scores were blinded to the group assignment because the patient was covered with surgical drape. Outcome assessors also blinded to group assignment because anxiety level assessed after the intervention was over, the head mounted device has already removed from patient. So, the outcome assessor didn’t know which one is the intervention group or control group. 3 Healthy Subject. Intervention 1: Intervention group:. Intervention 2: Control group:. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Taufan Pramadika
No 32, Mintojiwo Dalam 3
Semarang Indonesia 50149 +62 622 47611196 taufanpramadika@ymail.com Diponegoro University scientific Johan Arifin
No 11, Perum Jati Indah Raya
Semarang Indonesia 50268 +62 622 47078679 totud@ymail.com Diponegoro University Indonesia Male and female aged 18-50 years Graduated from high school/equivalent American Society of Anesthesiologists (ASA) physical status I-II Patients who are going to have lower abdominal or lower extremity surgery under regional anesthesia combined with spinal epidural neuraxial block No previous surgery history No history of epilepsy, psychiatric disorders, or claustrophobia and having visual acuity > 6/60 Patients with moderate to severe anxiety scores (Spielberger state-trait anxiety inventory [STAI] score > 38) 18 years 50 years Both Patients with shock or other major anesthetic or surgical complications during the procedure Patients who refused to participate in the study Regional anesthetic needle insertion >2 times VR device (Oculus Quest VR) that is damaged or error during the surgery process Patients who dropped out of this study Treatment - Devices Treatment - Drugs Intervention group: Control group: Anxiety score. Timepoint: Before intervention, after intervention, after surgery. Method of measurement: Patient's anxiety measured using Spielberger State-Trait Anxiety Inventory 6 (STAI-6), which is a shortened version of the original STAI (known as the Indonesian version of STAI). Blood Pressure, Heart Rate, Patient and Surgeon Satisfaction. Timepoint: Blood Pressure and heart rate measured every 10 minutes during the surgical procedure . Patient and Surgeon satisfaction measured after the surgery ended. Method of measurement: Blood pressure measured using automated sphygmomonometer. Heart rate measured using electrocardiograph. Patient and Surgeon satisfaction measured using questionnaire based on likert scale 1 - 10. Diponegoro University Approved 2021-10-14 Health Research Ethic Committee RSUP dr. Kariadi Semarang No. 16, dr Sutomo Street Semarang Central Java Indonesia