AnxietyNCT04598217
Is Virtual Reality a Non-pharmacological Premedication?
An observational study of Anxiety, run by Zonguldak Bulent Ecevit University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- anesthesiologist
- How many people
- 1 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2020to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients between the ages of 18-65 who will undergo septorhinoplasty surgery
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Zonguldak Bülent Ecevit University Medicine Faculty
Zonguldak, Kozlu, 67600
About this study
Official title: The Effect of Virtual Reality on Preoperative Anxiety in Septorhinoplasty Patients
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.
- Conditions
- Anxiety
- Being tested
- anesthesiologist
- Keywords
- Virtual Reality, Anxiety, Premedication
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anesthesiologistOther
non-interventional observational
What is being measured
The primary outcome is the main question the study is designed to answer.
to reduce preoperative anxiety
Investigation of the effect of virtual reality applications on preoperative anxiety
Measured: through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start1 Oct 2020
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zonguldak Bulent Ecevit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Çağdaş Baytar, Zonguldak Bulent Ecevit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04598217
- Sponsor's protocol ID
- 2020/19
- Status last verified
- Jan 2021
- First submitted
- 6 Oct 2020
- Last updated
- 26 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality on Preoperative Anxiety in Septorhinoplasty Patients
- ClinicalTrials.gov ID
- NCT04598217
- Acronym / sponsor ID
- 2020/19
- Conditions
- Anxiety
- Keywords
- Virtual Reality, Anxiety, Premedication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Zonguldak Bulent Ecevit UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 22 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients between the ages of 18-65 who will undergo septorhinoplasty surgery
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anesthesiologistnon-interventional observational | Other | – |
Primary outcome
to reduce preoperative anxiety
Time frame: through study completion, an average of 3 months
Investigation of the effect of virtual reality applications on preoperative anxiety
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety, run by Zonguldak Bulent Ecevit University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to reduce preoperative anxiety (time frame: through study completion, an average of 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2021.