An interventional study of Virtual Reality and Midazolam in VIRTUAL REALITY, sponsored by Derince Training and Research Hospital. Completed at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-07.
Sponsored by Derince Training and Research Hospital · Not applicable, Interventional, and Treatment
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The aim of the study is to evaluate the efficacy of virtual reality glasses on anxiety of the patients who underwent operations under spinal anesthesia during peroperative period. Both control group and VR group will be carry out STAI- Traıt anxiety test before operation and trait test after operation. Patients will be perform spinal anesthesia after standard sedation administration. After block reach adequate level for operation patients in VR group will wear the glasses and started to watch a documentary about birds and a sedative music by the headset. Patients in Control group will take standard anesthesia care. Hemodynamic changes (systemic blood pressure, heart rate, respiration rate and pSPO2) will be record in both groups.
The ASA score I-III Patients undergoing operation in OR under spinal anesthesia will be included in the study. Patients randomly assigned to VR group or Control Group. Patients will be carry out STAI-Trait Anxiety test preoperatively and second STAI test postoperatively. Spinal anesthesia will be performed after standard iv midazolam administration in both groups. After block reach adequate level for operation patient will wear the glasses and started to watch a documentary about birds and a sedative music by the headset in VR group and patient will take standard anesthesia care in Control group. The hemodynamic variables will be recorded during operation.
7,207 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.
This study's enrollment of 100 is above the median of 80 across 6,062 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Derince Training and Research Hospital is the lead sponsor of 39 studies on the registry; none are open to participants now.
Compared within Anxiety Disorders, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients watches 3D documentary videos on virtual reality glasses
Device: Virtual Reality · Drug: Midazolam
Patients do not watch virtual reality videos but will be administered iv sedative drugs before spinal attempt.
Drug: Midazolam
Patients will wear virtual reality glasses and start watching 3 D video after confirmation of adequate motor and sensorial block.
Also known as: VR
1-2 mg midazolam will be administered before spinal punction performed.
Also known as: Demizolam
State Anxiety Test
State Anxiety test will be perform at postop care unit
Time frame: postoperative 20th min.
Total tolerance time of Virtual Reality glasses
Total tolerance to VR glasses will be recorded
Time frame: intraoperative
incidence of vomiting
incidence of vomiting due to VR glasses
Time frame: intraoperative
incidence of nausea
incidence of nausea due to VR glasses
Time frame: intraoperative
incidence of dizziness
incidence of dizziness due to VR glasses
Time frame: intraoperative
incidence of headache
incidence of headache due to VR glasses
Time frame: intraoperative
Postoperative Visual Analog Scale Score
Patient will be asked his anxiety level by Visual analog scale (VAS) from 0 to 10. 0(= no anxiety), 10(= highest level of anxiety)
Time frame: postoperative 20 th min.
change in mean arterial pressure
blood pressure of the patient will be measured noninvasively from proper extremity in the operating room
Time frame: 5th min. intraoperative
change in mean arterial pressure
blood pressure of the patient will be measured noninvasively from proper extremity in the operating room
Time frame: 10th min. intraoperative
change in mean arterial pressure
blood pressure of the patient will be measured noninvasively from proper extremity in the operating room
Time frame: 15th min. intraoperative
change in mean arterial pressure
blood pressure of the patient will be measured noninvasively from proper extremity in the operating room
Time frame: 20th min. intraoperative
change in heart rate
heart rate of the patient will be monitored and recorded
Time frame: 5th min. intraoperative
change in heart rate
heart rate of the patient will be monitored and recorded
Time frame: 10th min. intraoperative
change in heart rate
heart rate of the patient will be monitored and recorded
Time frame: 15th min. intraoperative
change in heart rate
heart rate of the patient will be monitored and recorded
Time frame: 20th min. intraoperative
change in respiratory rate
respiratory rate of the patient will be monitored and recorded
Time frame: 5th min. intraoperative
change in respiratory rate
respiratory rate of the patient will be monitored and recorded
Time frame: 10th min. intraoperative
change in respiratory rate
respiratory rate of the patient will be monitored and recorded
Time frame: 15th min. intraoperative
change in respiratory rate
respiratory rate of the patient will be monitored and recorded
Time frame: 20th min. intraoperative
Ran from Nov 2017 to primary completion in Jul 2018, 7 months.
Of 3,841 non-industry interventional studies with no phase under Anxiety Disorders, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 28. This study's 7 months is below that.
Counting every sponsor, half of 3,943 studies reached it within 12 months; a quarter within 5 and three quarters within 28.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Derince Training and Research Hospital