Anxiety PostoperativeNCT05472246
The Effect of Virtual Reality Headset on Anxiety, Sedation Need
A study testing Wearing a virtual reality headset in people with Anxiety Postoperative and Anesthesia, run by Mesut Aslan at 1 site in Turkey (Türkiye).
Trial summary
In our clinic, our aim is to evaluate the effects of virtual reality technology on pain, anxiety, and additional anesthesia needs in patients undergoing port catheter implantation. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Anxiety Postoperative, Anesthesia, Patient Satisfaction
- What is being tested?
- Wearing a virtual reality headset
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 May 2022to 18 Jan 2023
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Oncological Patients
- Patients aged 18-70 years scheduled for port catheter implantation
- ASA 1-3 patients
Who cannot join
- Patients under 18 years of age and over 70 years of age.
- Patients with open wounds or infections around the face and eyes.
- Patients diagnosed with epilepsy or with a history of seizures for any reason.
- Patients using a pacemaker or an implanted medical device.
- Patients who do not speak Turkish.
- Patients with a history of psychiatric and neurological disorders.
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- Patients with a history of vertigo.
- Patients who are allergic to any of the drugs to be used in the study.
- Patients who have taken sedatives in the last 24 hours.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dr.Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
Istanbul
About this study
Official title: The Effect of Virtual Reality Headset on Anxiety, Sedation Need and Patient Satisfaction in Oncological Patients Scheduled for Port Catheter Implantation
In our clinic, our aim is to evaluate the effects of virtual reality technology on pain, anxiety, and additional anesthesia needs in patients undergoing port catheter implantation.
Read the detailed description
The patients will be randomly divided into 2 groups and one group will be shown relaxing videos (nature scenes) by wearing a VR headset in addition to the routine anesthesia procedure, while the control group will undergo the routine anesthesia procedure.
All patients are taken to the operating room, patients will be informed about the study and VR headsets, informed consent forms will be obtained, and preoperative anxiety levels will be evaluated with the STAI (state-transit anxiety inventory) questionnaire. Patients will be monitored in accordance with American Society of Anesthesiologist (ASA) standards within the routine anesthesia practices and vital signs (ECG: Electrocardiogram, Non-invasive SAP: Systolic arterial pressure, DAP: Diastolic arterial pressure, MAP: mean arterial pressure, HR: heart rate, SpO2: peripheral oxygen saturation) will be monitored and an intravenous cannula will be placed. In the VR group, the patient will wear the VR headset right before the surgical procedure starts and will be removed after the last surgical suture is performed. If the patient initially consents but wishes to remove the VR headset during the procedure or if the anesthesiologist considers it necessary, the headsets can be removed, and these patients will be recorded. An anesthesiologist and a study member will be present in the operating room to adjust VR headsets and help with technical issues. The anesthesiologist will apply routine anesthesia protocols to both groups, administer any additional medications deemed necessary, and any additional medications will be recorded. Each patient will receive midazolam 0.05 mg/kg IV and fentanyl 1 mcg/kg IV immediately after intravenous cannula placement as part of the routine sedation protocol of anesthesia. The sedation level of the patients will be targeted at 2-3 levels according to the Ramsey Sedation Scale and 1-2.5 mg/kg/hr IV propofol infusion will be given. The surgical team will administer local anesthesia. The onset of anesthesia will be recorded when midazolam is administered, the completion will be recorded when the patient awakens, and the duration of anesthesia will be recorded as the time between these two events. The beginning of surgery, the moment the surgeon performs the local anesthesia, the end of the surgery, the end of the last suture and the duration of the surgery will be recorded as the time between these two events. The postoperative anxiety level will be assessed with the STAI (State-Trait Anxiety Inventory) questionnaire 1 hour after the end of surgery (T2) in the post-anesthesia care unit (PACU). In this study, no additional monitoring and drug administration will be performed, except for the procedures included in the routine sedation protocol of anesthesia.
Primary data are the need for additional anesthetics (total intraoperative propofol dose in mg, additional opiod dose in mcg) and anxiety levels. Secondary data are hemodynamic data (MAP, HR, SpO2 will be recorded every 10 minutes), patient satisfaction, time to put on and adjust VR headsets, number of patients who refuse VR headsets, number of patients who remove VR headsets before the procedure ends. Demographic data (age, gender, weight, height, body mass index-BMI), ASA and comorbidities, duration of surgery and anesthesia will also be recorded.
- Conditions
- Anxiety Postoperative, Anesthesia, Patient Satisfaction
- Being tested
- Wearing a virtual reality headset
- Keywords
- VR, Anxiety, PortCatheter
- Medical subject headings
- Patient Satisfaction, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearing a virtual reality headsetDevice
VR group will be shown relaxing videos (nature scenes) by wearing a VR headset in addition to the routine anesthesia procedure
| Study group | Role | What they receive |
|---|---|---|
| VR group | Experimental | VR group will be shown relaxing videos (nature scenes) by wearing a VR headset in addition to the routine anesthesia procedure. Receives: Device: Wearing a virtual reality headset |
| Control group | No intervention | Control group will undergo the routine anesthesia procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
additional anesthetics
the need for additional anesthetics (total intraoperative propofol dose in mg, additional opiod dose in mcg)
Measured: peroperative
anxiety levels change
After all patients are taken to the operating room, patients will be informed about the study and VR headsets, informed consent forms will be obtained, and anxiety levels will be evaluated with the STAI (state-transit anxiety inventory) questionnaire. The postoperative anxiety level will be assessed with the STAI (State-Trait Anxiety Inventory) questionnaire 1 hour after the end of surgery (T2) in the post-anesthesia care unit (PACU).
Measured: 15 minutes before operatian and after 1 hour of operation
Secondary outcomes (8)
blood pressure change
Mean arterial blood pressure:mm Hg will be recorded every 10 minutes
Measured: Peroperative
heart rate change
heart rate: beat/minute will be recorded every 10 minutes
Measured: Peroperative
SpO2 change
SpO2:%0-100 will be recorded every 10 minutes
Measured: Peroperative
patient satisfaction
Patient satisfaction will be assessed and recorded using a 5-point patient satisfaction scale. (1: Extremely dissatisfied, 2: Dissatisfied, 3: Unknown or Uncertain, 4: Satisfied, 5: Extremely satisfied)
Measured: after 1 hour of operation
time to put on and adjust VR headsets
minute
Measured: Preoperative
number of patients who refuse VR headsets
number
Measured: preoperative
number of patients who remove VR headsets before the procedure ends
number
Measured: Peroperative
duration of surgery and anesthesia
minute
Measured: Peroperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study start18 May 2022
- Primary completion18 Oct 2022
- Study completion18 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety PostoperativeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Our study is a prospective, randomized, controlled, single-center study involving 200 patients aged 18-70 years who are scheduled for port catheter implantation procedure in Dr Siyami Ersek Thoracic Heart and Vascular Surgery Training and Research Hospital Thoracic Surgery Clinic. The patients will be randomly divided into 2 groups and one group will be shown relaxing videos (nature scenes) by wearing a VR headset in addition to the routine anesthesia procedure, while the control group will undergo the routine anesthesia procedure.
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mesut Aslan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mesut Aslan, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
- Investigators
- Hilal Yavuzel, Principal investigator, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research HospitalTülin Satılmış, Principal investigator, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research HospitalMesut Aslan, Principal investigator, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05472246
- Sponsor's protocol ID
- VRsedation
- Status last verified
- Apr 2024
- First submitted
- 19 Jul 2022
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality Headset on Anxiety, Sedation Need and Patient Satisfaction in Oncological Patients Scheduled for Port Catheter Implantation
- ClinicalTrials.gov ID
- NCT05472246
- Acronym / sponsor ID
- VRsedation
- Conditions
- Anxiety Postoperative, Anesthesia, Patient Satisfaction
- Keywords
- VR, Anxiety, PortCatheter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Mesut AslanUniversity, hospital or other
- Study start
- 18 May 2022 (actual)
- Primary completion
- 18 Oct 2022 (actual)
- Study completion
- 18 Jan 2023 (actual)
- First posted
- 25 Jul 2022 (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.
In our clinic, our aim is to evaluate the effects of virtual reality technology on pain, anxiety, and additional anesthesia needs in patients undergoing port catheter implantation.
Detailed description
The patients will be randomly divided into 2 groups and one group will be shown relaxing videos (nature scenes) by wearing a VR headset in addition to the routine anesthesia procedure, while the control group will undergo the routine anesthesia procedure.
All patients are taken to the operating room, patients will be informed about the study and VR headsets, informed consent forms will be obtained, and preoperative anxiety levels will be evaluated with the STAI (state-transit anxiety inventory) questionnaire. Patients will be monitored in accordance with American Society of Anesthesiologist (ASA) standards within the routine anesthesia practices and vital signs (ECG: Electrocardiogram, Non-invasive SAP: Systolic arterial pressure, DAP: Diastolic arterial pressure, MAP: mean arterial pressure, HR: heart rate, SpO2: peripheral oxygen saturation) will be monitored and an intravenous cannula will be placed. In the VR group, the patient will wear the VR headset right before the surgical procedure starts and will be removed after the last surgical suture is performed. If the patient initially consents but wishes to remove the VR headset during the procedure or if the anesthesiologist considers it necessary, the headsets can be removed, and these patients will be recorded. An anesthesiologist and a study member will be present in the operating room to adjust VR headsets and help with technical issues. The anesthesiologist will apply routine anesthesia protocols to both groups, administer any additional medications deemed necessary, and any additional medications will be recorded. Each patient will receive midazolam 0.05 mg/kg IV and fentanyl 1 mcg/kg IV immediately after intravenous cannula placement as part of the routine sedation protocol of anesthesia. The sedation level of the patients will be targeted at 2-3 levels according to the Ramsey Sedation Scale and 1-2.5 mg/kg/hr IV propofol infusion will be given. The surgical team will administer local anesthesia. The onset of anesthesia will be recorded when midazolam is administered, the completion will be recorded when the patient awakens, and the duration of anesthesia will be recorded as the time between these two events. The beginning of surgery, the moment the surgeon performs the local anesthesia, the end of the surgery, the end of the last suture and the duration of the surgery will be recorded as the time between these two events. The postoperative anxiety level will be assessed with the STAI (State-Trait Anxiety Inventory) questionnaire 1 hour after the end of surgery (T2) in the post-anesthesia care unit (PACU). In this study, no additional monitoring and drug administration will be performed, except for the procedures included in the routine sedation protocol of anesthesia.
Primary data are the need for additional anesthetics (total intraoperative propofol dose in mg, additional opiod dose in mcg) and anxiety levels. Secondary data are hemodynamic data (MAP, HR, SpO2 will be recorded every 10 minutes), patient satisfaction, time to put on and adjust VR headsets, number of patients who refuse VR headsets, number of patients who remove VR headsets before the procedure ends. Demographic data (age, gender, weight, height, body mass index-BMI), ASA and comorbidities, duration of surgery and anesthesia will also be recorded.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Our study is a prospective, randomized, controlled, single-center study involving 200 patients aged 18-70 years who are scheduled for port catheter implantation procedure in Dr Siyami Ersek Thoracic Heart and Vascular Surgery Training and Research Hospital Thoracic Surgery Clinic. The patients will be randomly divided into 2 groups and one group will be shown relaxing videos (nature scenes) by wearing a VR headset in addition to the routine anesthesia procedure, while the control group will undergo the routine anesthesia procedure.
| Arm | Type | Receives |
|---|---|---|
| VR group | Experimental | Device: Wearing a virtual reality headsetVR group will be shown relaxing videos (nature scenes) by wearing a VR headset in addition to the routine anesthesia procedure. |
| Control group | No intervention | –Control group will undergo the routine anesthesia procedure. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Oncological Patients
- Patients aged 18-70 years scheduled for port catheter implantation
- ASA 1-3 patients
Key exclusion criteria (9 listed)
- Patients under 18 years of age and over 70 years of age.
- Patients with open wounds or infections around the face and eyes.
- Patients diagnosed with epilepsy or with a history of seizures for any reason.
- Patients using a pacemaker or an implanted medical device.
- Patients who do not speak Turkish.
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 |
|---|---|---|
| Wearing a virtual reality headsetVR group will be shown relaxing videos (nature scenes) by wearing a VR headset in addition to the routine anesthesia procedure | Device | VR group |
Primary outcome
additional anesthetics
Time frame: peroperative
the need for additional anesthetics (total intraoperative propofol dose in mg, additional opiod dose in mcg)
anxiety levels change
Time frame: 15 minutes before operatian and after 1 hour of operation
After all patients are taken to the operating room, patients will be informed about the study and VR headsets, informed consent forms will be obtained, and anxiety levels will be evaluated with the STAI (state-transit anxiety inventory) questionnaire. The postoperative anxiety level will be assessed with the STAI (State-Trait Anxiety Inventory) questionnaire 1 hour after the end of surgery (T2) in the post-anesthesia care unit (PACU).
8 secondary outcomes
blood pressure change
Time frame: Peroperative
heart rate change
Time frame: Peroperative
SpO2 change
Time frame: Peroperative
patient satisfaction
Time frame: after 1 hour of operation
time to put on and adjust VR headsets
Time frame: Preoperative
number of patients who refuse VR headsets
Time frame: preoperative
number of patients who remove VR headsets before the procedure ends
Time frame: Peroperative
duration of surgery and anesthesia
Time frame: Peroperative
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 17 Apr 2024.
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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.
Hilal Yavuzel principal investigator
Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
Tülin Satılmış principal investigator
Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
Mesut Aslan principal investigator
Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wearing a virtual reality headset in people with Anxiety Postoperative and Anesthesia, run by Mesut Aslan 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 3 inclusion and 9 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 17 Apr 2024. 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?
additional anesthetics (time frame: peroperative). The study lists 2 primary outcomes in all. 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 17 Apr 2024.