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The Effect of Virtual Reality Glasses on Anxiety During Surgery Under Spinal Anesthesia

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03475810
Acronym
VR
Enrollment
100
Registered
2018-03-23
Start date
2017-11-07
Completion date
2018-07-01
Last updated
2023-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

VIRTUAL REALITY

Keywords

VIRTUAL REALITY, ANXIETY, SPINAL ANESTHESIA

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.

Interventions

DEVICEVirtual Reality

Patients will wear virtual reality glasses and start watching 3 D video after confirmation of adequate motor and sensorial block.

DRUGMidazolam

1-2 mg midazolam will be administered before spinal punction performed.

Sponsors

Derince Training and Research Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
State Anxiety Testpostoperative 20th min.State Anxiety test will be perform at postop care unit

Secondary

MeasureTime frameDescription
incidence of vomitingintraoperativeincidence of vomiting due to VR glasses
incidence of nauseaintraoperativeincidence of nausea due to VR glasses
incidence of dizzinessintraoperativeincidence of dizziness due to VR glasses
incidence of headacheintraoperativeincidence of headache due to VR glasses
Total tolerance time of Virtual Reality glassesintraoperativeTotal tolerance to VR glasses will be recorded
change in mean arterial pressure5th min. intraoperativeblood pressure of the patient will be measured noninvasively from proper extremity in the operating room
change in heart rate5th min. intraoperativeheart rate of the patient will be monitored and recorded
change in respiratory rate5th min. intraoperativerespiratory rate of the patient will be monitored and recorded
Postoperative Visual Analog Scale Scorepostoperative 20 th min.Patient will be asked his anxiety level by Visual analog scale (VAS) from 0 to 10. 0(= no anxiety), 10(= highest level of anxiety)

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026