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AzTrials

Anxiety PostoperativeNCT05472246

The Effect of Virtual Reality Headset on Anxiety, Sedation Need

A study testing Wearing a virtual reality headset in people with Anxiety Postoperative and Anesthesia, run by Mesut Aslan at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Wearing a virtual reality headset
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteTurkey (Türkiye)
Study dates
18 May 2022to 18 Jan 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.
Show all 9Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Dr.Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital

    Istanbul

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the 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.

Being tested
Wearing a virtual reality headset
Keywords
VR, Anxiety, PortCatheter
Medical subject headings
Patient Satisfaction, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Wearing a virtual reality headsetDevice

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

Study groups in NCT05472246
Study groupRoleWhat they receive
VR groupExperimentalVR group will be shown relaxing videos (nature scenes) by wearing a VR headset in addition to the routine anesthesia procedure.
Receives: Device: Wearing a virtual reality headset
Control groupNo interventionControl group will undergo the routine anesthesia procedure.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. additional anesthetics

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

    Measured: peroperative

  2. 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).

    Measured: 15 minutes before operatian and after 1 hour of operation

Secondary outcomes (8)
  1. blood pressure change

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

    Measured: Peroperative

  2. heart rate change

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

    Measured: Peroperative

  3. SpO2 change

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

    Measured: Peroperative

  4. 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)

    Measured: after 1 hour of operation

  5. time to put on and adjust VR headsets

    minute

    Measured: Preoperative

  6. number of patients who refuse VR headsets

    number

    Measured: preoperative

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

    number

    Measured: Peroperative

  8. duration of surgery and anesthesia

    minute

    Measured: Peroperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2022
  2. Study start18 May 2022
  3. Primary completion18 Oct 2022
  4. Study completion18 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05472246
Sponsor's protocol ID
VRsedation
Status last verified
Apr 2024
First submitted
19 Jul 2022
Last updated
17 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Wearing a virtual reality headset in people with Anxiety Postoperative and Anesthesia, run by Mesut Aslan at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

additional anesthetics (time frame: peroperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024.

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