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

NCT03475810 | Completed

• 1 other identifier: DerinceTRH-02
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

VIRTUAL REALITY

Keywords

VIRTUAL REALITY; ANXIETY; SPINAL ANESTHESIA

Outcome Measures

Primary Outcomes (1)

• State Anxiety Test

  State Anxiety test will be perform at postop care unit

  postoperative 20th min.

Secondary Outcomes (18)

• Total tolerance time of Virtual Reality glasses

  intraoperative

• incidence of vomiting

  intraoperative

• incidence of nausea

  intraoperative

• incidence of dizziness

  intraoperative

• incidence of headache

  intraoperative

Study Arms (2)

VR GROUP

EXPERIMENTAL

Patients watches 3D documentary videos on virtual reality glasses

Device: Virtual Reality; Drug: Midazolam

midazolam

ACTIVE COMPARATOR

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

Drug: Midazolam

Interventions

Virtual Reality DEVICE

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

Also known as: VR

VR GROUP

Midazolam DRUG

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

Also known as: Demizolam

VR GROUP; midazolam

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18
• Patients who undergo surgery under spinal anesthesia
• American Society of Anesthesiologists (ASA) physical status classification I-III

You may not qualify if:

• patients undergo urgent operations
• patients have psychiatric disorders

Sponsors & Collaborators

• Derince Training and Research Hospital: lead

Study Sites (1)

Derince Research and Training Hospital

Kocaeli, 41900, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Midazolam

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Ayse Zeynep Turan, MD

  Derince Research and Training Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: March 17, 2018
• First Posted: March 23, 2018
• Study Start: November 7, 2017
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: September 7, 2023

Record last verified: 2023-09

Locations

TU (1)