Virtual Reality (VR) Tour to Reduce Preoperative Anxiety Before Anaesthesia (VR OP- tour)

March 11, 2021 updated by: RWTH Aachen University

Virtual Reality (VR) Tour to Reduce Preoperative Anxiety Before Anaesthesia in an Operating Setting: A Randomized Clinical Trial

Anxiety and apprehension are common among patients prior to surgery. This anxiety can lead to additional discomfort, increased pain sensation and increased stress symptoms. Virtual exposure has proven to be successful in exposure therapy for the treatment of the narrowest patients. Patients are not confronted with the real stimuli or situations that trigger the branches, but with virtual representations of them. Virtual reality (VR) makes it possible to create scenarios that would not be possible in reality because of the organisational, time or financial expenditure involved.The effectiveness of virtual stimulus exposure is well documented, especially in the case of object or situation-related fears in the context of specific phobias. It is therefore obvious that virtual stimulus exposure could also be suitable for minimising operation-associated fears.The research project described is designed to investigate the effect of virtual stimulus exposure on perioperative anxiety. For this purpose, a virtual tour of the operating setting has been created, which enables patients to explore the surroundings in detail by means of VR glasses.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Anxiety and apprehension are common among patients prior to surgery. This anxiety can lead to additional discomfort, increased pain sensation and increased stress symptoms. Virtual exposure has proven to be successful in exposure therapy for the treatment of the narrowest patients. Patients are not confronted with the real stimuli or situations that trigger the branches, but with virtual representations of them. Virtual reality (VR) makes it possible to create scenarios that would not be possible in reality because of the organisational, time or financial expenditure involved.The effectiveness of virtual stimulus exposure is well documented, especially in the case of object or situation-related fears in the context of specific phobias. It is therefore obvious that virtual stimulus exposure could also be suitable for minimising operation-associated fears.The research project described is designed to investigate the effect of virtual stimulus exposure on perioperative anxiety. For this purpose, a virtual tour of the operating setting has been created, which enables patients to explore the surroundings in detail by means of VR glasses.

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • NRW
      • Aachen, NRW, Germany, 52074
        • RWTH Aachen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • all patient undergoing anaesthesia without the following exclusion criteria

Exclusion Criteria:

  • < 18 years
  • cancer surgery
  • pregnancy
  • postoperative setting ICU
  • neurosurgery
  • Thorax surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standardized Anaesthesia briefing
standardised anaesthesia information sessions, consisting of a detailed explanation of the anaesthesia procedure by the anaesthetist A specific information sheet is used to explain the procedure and the form of anaesthesia. This corresponds to the current procedure before an operation.
Experimental: Virtual reality (VR) tour
standardised anaesthesia information sessions, consisting of a detailed explanation of the anaesthesia procedure by the anaesthetist A specific information sheet is used to explain the procedure and the form of anaesthesia.Subsequently, the patients are shown a virtual tour of the operation using VR glasses. This includes the way through the clinic to the operating theatre: Admission -> inpatient preparation for the operation -> administration of premedication -> way to the operating theater -> OP preparation (holding) -> safe surgery
Other: virtual reality tour
Patients will be guided via VR on their way through the hospital to the operating theater

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
STOA State T1
Time Frame: before anaesthesia
Questinaire STOA State T1 before anaesthesia
before anaesthesia

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
STOA State T2
Time Frame: within 48 hours after anaesthesia
Questionaire STOA State T2 after anaesthesia
within 48 hours after anaesthesia

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RWTH Aachen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 7, 2020

Primary Completion (Actual)

October 30, 2020

Study Completion (Actual)

January 1, 2021

Study Registration Dates

First Submitted

October 1, 2020

First Submitted That Met QC Criteria

October 1, 2020

First Posted (Actual)

October 8, 2020

Study Record Updates

Last Update Posted (Actual)

March 15, 2021

Last Update Submitted That Met QC Criteria

March 11, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EK037/20
  • CTC-A 20-026 (Other Identifier: RWTH Aachen)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Anaesthesia

Clinical Trials on virtual reality tour

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Brazil

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe