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

NCT ID: NCT03475810

Last Updated: 2023-09-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-07
• Study Completion Date: 2018-07-01

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.

Conditions

VIRTUAL REALITY

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

VR GROUP

Patients watches 3D documentary videos on virtual reality glasses

Group Type: EXPERIMENTAL

Virtual Reality

Intervention Type: DEVICE

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

Midazolam

Intervention Type: DRUG

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

midazolam

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

Group Type: ACTIVE_COMPARATOR

Midazolam

Intervention Type: DRUG

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

Interventions

Virtual Reality

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

Intervention Type: DEVICE

Midazolam

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

Intervention Type: DRUG

Other Intervention Names

VR; Demizolam

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Derince Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ayse Zeynep Turan

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ayse Zeynep Turan, MD

Role: PRINCIPAL_INVESTIGATOR

Derince Research and Training Hospital

Locations

Derince Research and Training Hospital

Kocaeli, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

DerinceTRH-02

Identifier Type: -

Identifier Source: org_study_id