- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05472246
The Effect of Virtual Reality Headset on Anxiety, Sedation Need
The Effect of Virtual Reality Headset on Anxiety, Sedation Need and Patient Satisfaction in Oncological Patients Scheduled for Port Catheter Implantation
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hilal Yavuzel
- Phone Number: 90-505-8689715
- Email: hilal.yavuzell@gmail.com
Study Locations
-
-
-
Istanbul, Turkey
- Dr.Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Oncological Patients
- Patients aged 18-70 years scheduled for port catheter implantation
- ASA 1-3 patients
Exclusion Criteria:
- 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.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: VR group
VR group will be shown relaxing videos (nature scenes) by wearing a VR headset in addition to the routine anesthesia procedure.
|
VR group will be shown relaxing videos (nature scenes) by wearing a VR headset in addition to the routine anesthesia procedure
|
No Intervention: Control group
Control group will undergo the routine anesthesia procedure.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
additional anesthetics
Time Frame: peroperative
|
the need for additional anesthetics (total intraoperative propofol dose in mg, additional opiod dose in mcg)
|
peroperative
|
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).
|
15 minutes before operatian and after 1 hour of operation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
blood pressure change
Time Frame: Peroperative
|
Mean arterial blood pressure:mm Hg will be recorded every 10 minutes
|
Peroperative
|
heart rate change
Time Frame: Peroperative
|
heart rate: beat/minute will be recorded every 10 minutes
|
Peroperative
|
SpO2 change
Time Frame: Peroperative
|
SpO2:%0-100 will be recorded every 10 minutes
|
Peroperative
|
patient satisfaction
Time Frame: after 1 hour of operation
|
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)
|
after 1 hour of operation
|
time to put on and adjust VR headsets
Time Frame: Preoperative
|
minute
|
Preoperative
|
number of patients who refuse VR headsets
Time Frame: preoperative
|
number
|
preoperative
|
number of patients who remove VR headsets before the procedure ends
Time Frame: Peroperative
|
number
|
Peroperative
|
duration of surgery and anesthesia
Time Frame: Peroperative
|
minute
|
Peroperative
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hilal Yavuzel, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
- Principal Investigator: Tülin Satılmış, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
- Principal Investigator: Mesut Aslan, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- VRsedation
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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