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

Derince Training and Research Hospital

Status: Completed

Conditions: VIRTUAL REALITY

Treatments: Device: Virtual Reality; Drug: Midazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT03475810

DerinceTRH-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

VR GROUP

Experimental group

Description:

Patients watches 3D documentary videos on virtual reality glasses

Treatment:

Drug: Midazolam

Device: Virtual Reality

midazolam

Active Comparator group

Description:

Patients do not watch virtual reality videos but will be administered iv sedative drugs before spinal attempt.

Treatment:

Drug: Midazolam