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IRCT20180331039164N1 IRCT 2019-02-05 Ahvaz University of Medical Sciences Effect of virtual reality glasses on intra-operative pain during lithotripsy The effect of virtual reality glasses on intra-operative stress and pain during intra-corporeal lithotripsy under spinal anesthesia 2019-02-04 anticipated 90 Complete https://irct.ir/trial/36597 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Assignment of patients in two groups of test and control will be done by Block Balanced Randomization (BBR) method. The Randomization Sequence will be generated with using the free website at http://www.randomization.com. N/A Calculus of ureter. Intervention 1: Intervention group: Patients in the intervention group use virtual reality glasses (Quilo brand) from the 10 minutes before surgery until the end of the procedure. Intervention 2: Control group: There is no intervention in the control group during surgery. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information.
public Dinyar Khazaeli
Department of Urology, Imam Khomeini Hospital, Azadegan St
Ahvaz Iran (Islamic Republic of) 15794-61357 +98 61 3222 2114 khazaeli-d@ajums.ac.ir Ahvaz University of Medical Sciences scientific Amir Mohammad Papan
Ahvaz Jundishapur University of Medical Sciences., Golestan Highway., Ahvaz Town
Ahvaz Iran (Islamic Republic of) 6193673166 +98 61 3441 1798 amirmohammadpapan@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) From 18 years old to 65 years old Candidate for Trans Ureteral Lithotripsy for ureteral stone 18 years 65 years Both Patients who need complete anesthesia. Patients in need of emergency surgery Significant impairments of the senses of vision and hearing History of epilepsy People who suffer from headache, nausea and vomiting due to using the glasses. N20.1 Calculus of ureter Treatment - Devices N/A Intervention group: Patients in the intervention group use virtual reality glasses (Quilo brand) from the 10 minutes before surgery until the end of the procedure. Control group: There is no intervention in the control group during surgery. The stress level of patients according to State-trait Anxiety Inventory. Timepoint: At the beginning of study (before the surgery) and after the end of surgery. Method of measurement: State-trait Anxiety Inventory. Pain acording to VAS scale. Timepoint: At the beginning of study (before the surgery) and after the end of surgery. Method of measurement: asking the patient acording to VAS scoring system. Patient's Blood Pressure before, every 10 minutes and after surgery. Timepoint: At the beginning of study (before the surgery) and after the end of surgery. Method of measurement: holter monitoring. Patient's pulse rate before, every 10 minutes and after surgery. Timepoint: continues before, during and after surgery. Method of measurement: continues ECG monitoring. Side effects. Timepoint: Every 20 minutes during the surgery and at the end of surgery. Method of measurement: Clinical observations. Ahvaz University of Medical Sciences Approved 2018-03-06 Ethics committee of Ahvaz Jundishapur University of Medical Sciences Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd Ahvaz Khouzestan Iran (Islamic Republic of)