The Effect of Virtual Reality Headset on Anxiety, Sedation Need

NCT ID: NCT05472246

Last Updated: 2024-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-18
• Study Completion Date: 2023-01-18

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.

Conditions

Anxiety Postoperative; Anesthesia; Patient Satisfaction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

VR group

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

Group Type: EXPERIMENTAL

Wearing a virtual reality headset

Intervention Type: DEVICE

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

Control group

Control group will undergo the routine anesthesia procedure.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Wearing a virtual reality headset

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mesut Aslan

OTHER

Sponsor Role: lead

Responsible Party

Mesut Aslan

Asistant Doctor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Hilal Yavuzel

Role: PRINCIPAL_INVESTIGATOR

Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital

Tülin Satılmış

Role: PRINCIPAL_INVESTIGATOR

Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital

Mesut Aslan

Role: PRINCIPAL_INVESTIGATOR

Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital

Locations

Dr.Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

VRsedation

Identifier Type: -

Identifier Source: org_study_id