Is Virtual Reality a Non-pharmacological Premedication? | NCT04598217

Studies
Is Virtual Reality a Non-pharmacological Premedication?

NCT04598217

Sponsor

Zonguldak Bulent Ecevit University

Status

Completed

Last Update Posted

Jan 26, 2021Actual

Enrollment

1Actual

Phase

Not provided

Conditions

Anxiety

Interventions

anesthesiologist

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2020Actual

Primary Completion Date

Dec 31, 2020Actual

Completion Date

Dec 31, 2020Actual

First Submitted Date

Oct 6, 2020

First Submission Date that Met QC Criteria

Oct 15, 2020

First Posted Date

Oct 22, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 24, 2021

Last Update Posted Date

Jan 26, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Çağdaş Baytar, assistant professor, Zonguldak Bulent Ecevit UniversityPrincipal Investigator

Lead Sponsor

Zonguldak Bulent Ecevit UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Preoperative anxiety of patients who will undergo septorhinoplasty surgery will be measured and their hemodynamic parameters will be recorded afterwards. Then, a video will be shown to the patients through virtual reality glasses and the effect of this application on their anxiety will be investigated.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1Actual

Name	Type	Description	Arm Group Labels	Other Names
anesthesiologist	Other	non-interventional observational

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
to reduce preoperative anxiety	Investigation of the effect of virtual reality applications on preoperative anxiety	through study completion, an average of 3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ASA I-II risk group
Will be operated under general anesthesia under elective conditions
Going to undergo surgery for septoplasty / rhinoplasty
Patients whose informed consent was read and approved

Exclusion Criteria:

Those who do not want to participate in the study
ASA III - IV-V patients
Psychiatric-Cognitive dysfunction
Claustrophobia
Patients using sedative and narcotic drugs
Alcohol-drug addicts
Blind or deaf patients
Patients who cannot speak Turkish

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Patients between the ages of 18-65 who will undergo septorhinoplasty surgery

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zonguldak Bülent Ecevit University Medicine Faculty		Zonguldak	Kozlu	67600	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D001008	Anxiety Disorders

ID	Term
D001523	Mental Disorders

Intervention Browse Module

MeSH Terms

ID	Term
D000072080	Anesthesiologists

Ancestor Terms

ID	Term
D000072077	Anesthetists
D006282	Health Personnel
D005159	Health Care Facilities Workforce and Services
D010820	Physicians

Browse Leaves

Not provided

Browse Branches

Not provided