Efficacy of Virtual Reality Distraction Technique for Anxiety and Pain Control in Orthopedic Forearm Surgeries Performed Under Supraclavicular Brachial Plexus Block

NCT05512728 | Unknown

• 1 other identifier: MS-389-2020
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

Invistigators hypothesized that using of VR distraction technique during performing peripheral regional anesthesia (supraclavicular block) would lead to better perioperative analgesia and less anxiety.

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

• ● To estimate amount of IV sedation needed for the patient

  (time from block needle entry till the end of the procedure)

Study Arms (2)

midazolam group

PLACEBO COMPARATOR

Drug: Midazolam

VR group

ACTIVE COMPARATOR

Device: VR

Interventions

VR DEVICE

The IVR environment was provided by Shinecon VR (Shinecon, china). Shinecon VR features, have a large field of view and high-quality display; with aspheric lens , lens diameter 40MM, view angle 108 , sharpness 99%, visibility 100%, color .38MM and pupillary distance adjustment 65 MM. The shinecon VR setup was powered by a HUAWEI Y7 prime phone running the freely available IVR software. Shinecon VR provides videos for nature, forest, wind, desert and animals. That included noise-cancelling headphones playing background sound from the IVR simulation.

VR group

Midazolam DRUG

• (titration of 0.05 mg/kg per dose) according to Modified Wilson sedation scale Score to achieve grade 1 (Oriented, eyes may be closed but can respond to 'Can you tell me your name?' 'Can you tell me where you are right now?'

midazolam group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ASA physical status I-II. patients scheduled for elective forearm orthopedic surgeries under ultrasound guided supraclavicular approach for brachial plexus block with good mental function.

You may not qualify if:

• Patient's refusal.
• Known allergy to local anesthetics.
• Bleeding disorders, Use of any anti-coagulants.
• Inability to provide informed consent.
• Patient with psychiatric disorders.
• Sensory impairment (blindness, deafness).
• Any technical problem preventing proper fitting of the glasses to the patient face
• patients with cognitive impairment, epilepsy or with claustrophobia
• patients with suspected eye infection

Sponsors & Collaborators

• Cairo University: lead

Study Sites (2)

Kasr Alainy

Cairo, 11617, Egypt

Location

Kasr Alainy

Cairo, Egypt

Location

MeSH Terms

Interventions

Midazolam

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anasthesia and pain management

Model Details: Categorical variables will be assessed using the chi-square or Fischer's exact test where appropriate. Normally distributed data will be presented as the mean (SD). Midazolam consumption and hemodynamic variables with a normal distribution will be analyzed using two-way analyses of variance with repeated measures and Dennett's post hoc test as appropriate. Data that are not normally distributed (by the Kolmogorov-Smirnov test) are presented as the median (range) and will be analyzed with the Kruskal-Wallis test as appropriate. The software SPSS v15.0 for Windows (SPSS, Inc, Chicago, IL, United States) will be used for statistical analysis

Study Record Dates

• First Submitted: August 20, 2022
• First Posted: August 23, 2022
• Study Start: December 20, 2020
• Primary Completion: December 20, 2022
• Study Completion: December 20, 2022
• Last Updated: August 31, 2022

Record last verified: 2022-08

Locations

EG (2)