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The Effect of Virtual Reality Headset on Anxiety, Sedation Need

Primary Purpose

Anxiety Postoperative, Anesthesia, Patient Satisfaction

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Wearing a virtual reality headset
Sponsored by
Mesut Aslan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anxiety Postoperative focused on measuring VR, Anxiety, PortCatheter

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Oncological Patients
  2. Patients aged 18-70 years scheduled for port catheter implantation
  3. ASA 1-3 patients

Exclusion Criteria:

  1. Patients under 18 years of age and over 70 years of age.
  2. Patients with open wounds or infections around the face and eyes.
  3. Patients diagnosed with epilepsy or with a history of seizures for any reason.
  4. Patients using a pacemaker or an implanted medical device.
  5. Patients who do not speak Turkish.
  6. Patients with a history of psychiatric and neurological disorders.
  7. Patients with a history of vertigo.
  8. Patients who are allergic to any of the drugs to be used in the study.
  9. Patients who have taken sedatives in the last 24 hours.

Sites / Locations

  • Dr.Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

VR group

Control group

Arm Description

VR group will be shown relaxing videos (nature scenes) by wearing a VR headset in addition to the routine anesthesia procedure.

Control group will undergo the routine anesthesia procedure.

Outcomes

Primary Outcome Measures

additional anesthetics
the need for additional anesthetics (total intraoperative propofol dose in mg, additional opiod dose in mcg)
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).

Secondary Outcome Measures

blood pressure change
Mean arterial blood pressure:mm Hg will be recorded every 10 minutes
heart rate change
heart rate: beat/minute will be recorded every 10 minutes
SpO2 change
SpO2:%0-100 will be recorded every 10 minutes
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)
time to put on and adjust VR headsets
minute
number of patients who refuse VR headsets
number
number of patients who remove VR headsets before the procedure ends
number
duration of surgery and anesthesia
minute

Full Information

First Posted
July 19, 2022
Last Updated
July 22, 2022
Sponsor
Mesut Aslan
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1. Study Identification

Unique Protocol Identification Number
NCT05472246
Brief Title
The Effect of Virtual Reality Headset on Anxiety, Sedation Need
Official Title
The Effect of Virtual Reality Headset on Anxiety, Sedation Need and Patient Satisfaction in Oncological Patients Scheduled for Port Catheter Implantation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 18, 2022 (Actual)
Primary Completion Date
October 18, 2022 (Anticipated)
Study Completion Date
November 18, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mesut Aslan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Postoperative, Anesthesia, Patient Satisfaction
Keywords
VR, Anxiety, PortCatheter

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
VR group
Arm Type
Experimental
Arm Description
VR group will be shown relaxing videos (nature scenes) by wearing a VR headset in addition to the routine anesthesia procedure.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Control group will undergo the routine anesthesia procedure.
Intervention Type
Device
Intervention Name(s)
Wearing a virtual reality headset
Intervention Description
VR group will be shown relaxing videos (nature scenes) by wearing a VR headset in addition to the routine anesthesia procedure
Primary Outcome Measure Information:
Title
additional anesthetics
Description
the need for additional anesthetics (total intraoperative propofol dose in mg, additional opiod dose in mcg)
Time Frame
peroperative
Title
anxiety levels change
Description
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).
Time Frame
15 minutes before operatian and after 1 hour of operation
Secondary Outcome Measure Information:
Title
blood pressure change
Description
Mean arterial blood pressure:mm Hg will be recorded every 10 minutes
Time Frame
Peroperative
Title
heart rate change
Description
heart rate: beat/minute will be recorded every 10 minutes
Time Frame
Peroperative
Title
SpO2 change
Description
SpO2:%0-100 will be recorded every 10 minutes
Time Frame
Peroperative
Title
patient satisfaction
Description
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)
Time Frame
after 1 hour of operation
Title
time to put on and adjust VR headsets
Description
minute
Time Frame
Preoperative
Title
number of patients who refuse VR headsets
Description
number
Time Frame
preoperative
Title
number of patients who remove VR headsets before the procedure ends
Description
number
Time Frame
Peroperative
Title
duration of surgery and anesthesia
Description
minute
Time Frame
Peroperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hilal Yavuzel
Phone
90-505-8689715
Email
hilal.yavuzell@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hilal Yavuzel
Organizational Affiliation
Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tülin Satılmış
Organizational Affiliation
Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mesut Aslan
Organizational Affiliation
Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr.Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hilal Yavuzel, MD
Phone
00905058689715
Email
hilal.yavuzell@gmail.com
First Name & Middle Initial & Last Name & Degree
Tulin Satilmis, Asc. Prof
Phone
00905322034839
Email
drtulinsatilmis@yahoo.com.tr
First Name & Middle Initial & Last Name & Degree
Hilal Yavuzel, MD

12. IPD Sharing Statement

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The Effect of Virtual Reality Headset on Anxiety, Sedation Need

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