Skip to main content
OpenTrials
Completed

NCT Number: NCT05472246

The Effect of Virtual Reality Headset on Anxiety, Sedation Need

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. additional anesthetics

    Time frame: peroperative

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

  2. 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).

Secondary outcomes

  1. blood pressure change

    Time frame: Peroperative

    Mean arterial blood pressure:mm Hg will be recorded every 10 minutes

  2. heart rate change

    Time frame: Peroperative

    heart rate: beat/minute will be recorded every 10 minutes

  3. SpO2 change

    Time frame: Peroperative

    SpO2:%0-100 will be recorded every 10 minutes

  4. 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)

  5. time to put on and adjust VR headsets

    Time frame: Preoperative

    minute

  6. number of patients who refuse VR headsets

    Time frame: preoperative

    number

  7. number of patients who remove VR headsets before the procedure ends

    Time frame: Peroperative

    number

  8. duration of surgery and anesthesia

    Time frame: Peroperative

    minute

Sponsors and collaborators

Lead sponsor

Mesut Aslan

Other

Registry information

Official study title

The Effect of Virtual Reality Headset on Anxiety, Sedation Need and Patient Satisfaction in Oncological Patients Scheduled for Port Catheter Implantation

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Jul 25, 2022
Registry last updated
Apr 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.