The Effect of Virtual Reality Headset on Anxiety, Sedation Need

NCT05472246 | Completed

• 1 other identifier: VRsedation
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety Postoperative; Anesthesia; Patient Satisfaction

Keywords

VR; Anxiety; PortCatheter

Outcome Measures

Primary Outcomes (2)

• additional anesthetics

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

  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).

  15 minutes before operatian and after 1 hour of operation

Secondary Outcomes (8)

• blood pressure change

  Peroperative

• heart rate change

  Peroperative

• SpO2 change

  Peroperative

• patient satisfaction

  after 1 hour of operation

• time to put on and adjust VR headsets

  Preoperative

Study Arms (2)

VR group

EXPERIMENTAL

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

Device: Wearing a virtual reality headset

Control group

NO INTERVENTION

Control group will undergo the routine anesthesia procedure.

Interventions

Wearing a virtual reality headset DEVICE

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

VR group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mesut Aslan: lead

Study Sites (1)

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

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Patient Satisfaction; Anxiety Disorders

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior; Mental Disorders

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Asistant Doctor

Model Details: 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.

Study Record Dates

• First Submitted: July 19, 2022
• First Posted: July 25, 2022
• Study Start: May 18, 2022
• Primary Completion: October 18, 2022
• Study Completion: January 18, 2023
• Last Updated: April 17, 2024

Record last verified: 2024-04

Locations

TU (1)