Clinical trial NCT03475810: The Effect of Virtual Reality Glasses on Anxiety During Surgery Under Spinal Anesthesia
Official title: The Effect of Virtual Reality Glasses on Anxiety During Surgery Under Spinal Anesthesia: A Randomize Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: VIRTUAL REALITY
Keywords: VIRTUAL REALITY
ANXIETY
SPINAL ANESTHESIA
Lead sponsor: Derince Training and Research Hospital
Sponsor class: OTHER
First posted: 2018-03-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

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

Primary outcomes:
measure: State Anxiety Test
timeFrame: postoperative 20th min.
Secondary outcomes:
measure: Total tolerance time of Virtual Reality glasses
timeFrame: intraoperative
measure: incidence of vomiting
timeFrame: intraoperative
measure: incidence of nausea
timeFrame: intraoperative
measure: incidence of dizziness
timeFrame: intraoperative
measure: incidence of headache
timeFrame: intraoperative
measure: Postoperative Visual Analog Scale Score
timeFrame: postoperative 20 th min.
measure: change in mean arterial pressure
timeFrame: 5th min. intraoperative
measure: change in mean arterial pressure
timeFrame: 10th min. intraoperative
measure: change in mean arterial pressure
timeFrame: 15th min. intraoperative
measure: change in mean arterial pressure
timeFrame: 20th min. intraoperative
measure: change in heart rate
timeFrame: 5th min. intraoperative
measure: change in heart rate
timeFrame: 10th min. intraoperative
measure: change in heart rate
timeFrame: 15th min. intraoperative
measure: change in heart rate
timeFrame: 20th min. intraoperative
measure: change in respiratory rate
timeFrame: 5th min. intraoperative
measure: change in respiratory rate
timeFrame: 10th min. intraoperative
measure: change in respiratory rate
timeFrame: 15th min. intraoperative
measure: change in respiratory rate
timeFrame: 20th min. intraoperative
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Derince Research and Training Hospital
Study officials:
affiliation: Derince Research and Training Hospital
name: Ayse Zeynep Turan, MD
role: PRINCIPAL_INVESTIGATOR
References: