NCT04598217

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2020

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

October 6, 2020

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 22, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

January 26, 2021

Status Verified

January 1, 2021

Enrollment Period

3 months

First QC Date

October 6, 2020

Last Update Submit

January 24, 2021

Conditions

Anxiety

Keywords

Virtual RealityAnxietyPremedication

Outcome Measures

Primary Outcomes (1)

  • to reduce preoperative anxiety

    Investigation of the effect of virtual reality applications on preoperative anxiety

    through study completion, an average of 3 months

Interventions

anesthesiologistOTHER

non-interventional observational

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zonguldak Bülent Ecevit University Medicine Faculty

Zonguldak, Kozlu, 67600, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Anesthesiologists

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

AnesthetistsHealth PersonnelHealth Care Facilities Workforce and ServicesPhysicians

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

October 6, 2020

First Posted

October 22, 2020

Study Start

October 1, 2020

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

January 26, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)