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Clinical trial

The Effect of Virtual Reality Glasses on Anxiety During Surgery Under Spinal Anesthesia: A Randomize Controlled Study

ID
Name
DerinceTRH-02
Description
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.
Trial arms
Trial start
2017-11-07
Estimated PCD
2018-07-01
Trial end
2018-07-01
Status
Completed
Treatment
Virtual Reality
Patients will wear virtual reality glasses and start watching 3 D video after confirmation of adequate motor and sensorial block.
Arms:
VR GROUP
Other names:
VR
Midazolam
1-2 mg midazolam will be administered before spinal punction performed.
Arms:
VR GROUP, midazolam
Other names:
Demizolam
Size
100
Primary endpoint
State Anxiety Test
postoperative 20th min.
Eligibility criteria
Inclusion Criteria: * Age \>18 * Patients who undergo surgery under spinal anesthesia * American Society of Anesthesiologists (ASA) physical status classification I-III Exclusion Criteria: * patients undergo urgent operations * patients have psychiatric disorders
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 100, 'type': 'ACTUAL'}}
Updated at
2023-09-07

1 organization

1 product

1 indication

Organization
Derince Training and Research Hospital
Product
Midazolam
Indication
virtual reality