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

Primary Purpose

Anaesthesia, Anxiety, Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
virtual reality tour
Sponsored by
RWTH Aachen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anaesthesia focused on measuring virtual reality (VR), anxiety preoperative, opearting theater

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • all patient undergoing anaesthesia without the following exclusion criteria

Exclusion Criteria:

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

Sites / Locations

  • RWTH Aachen University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standardized Anaesthesia briefing

Virtual reality (VR) tour

Arm Description

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.

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

Outcomes

Primary Outcome Measures

STOA State T1
Questinaire STOA State T1 before anaesthesia

Secondary Outcome Measures

STOA State T2
Questionaire STOA State T2 after anaesthesia

Full Information

First Posted
October 1, 2020
Last Updated
March 11, 2021
Sponsor
RWTH Aachen University
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1. Study Identification

Unique Protocol Identification Number
NCT04579354
Brief Title
Virtual Reality (VR) Tour to Reduce Preoperative Anxiety Before Anaesthesia
Acronym
VR OP- tour
Official Title
Virtual Reality (VR) Tour to Reduce Preoperative Anxiety Before Anaesthesia in an Operating Setting: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
September 7, 2020 (Actual)
Primary Completion Date
October 30, 2020 (Actual)
Study Completion Date
January 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RWTH Aachen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anaesthesia, Anxiety, Postoperative Pain
Keywords
virtual reality (VR), anxiety preoperative, opearting theater

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standardized Anaesthesia briefing
Arm Type
No Intervention
Arm Description
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.
Arm Title
Virtual reality (VR) tour
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
virtual reality tour
Intervention Description
Patients will be guided via VR on their way through the hospital to the operating theater
Primary Outcome Measure Information:
Title
STOA State T1
Description
Questinaire STOA State T1 before anaesthesia
Time Frame
before anaesthesia
Secondary Outcome Measure Information:
Title
STOA State T2
Description
Questionaire STOA State T2 after anaesthesia
Time Frame
within 48 hours after anaesthesia

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: all patient undergoing anaesthesia without the following exclusion criteria Exclusion Criteria: < 18 years cancer surgery pregnancy postoperative setting ICU neurosurgery Thorax surgery
Facility Information:
Facility Name
RWTH Aachen University
City
Aachen
State/Province
NRW
ZIP/Postal Code
52074
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34252034
Citation
Vogt L, Klasen M, Rossaint R, Goeretz U, Ebus P, Sopka S. Virtual Reality Tour to Reduce Perioperative Anxiety in an Operating Setting Before Anesthesia: Randomized Clinical Trial. J Med Internet Res. 2021 Sep 1;23(9):e28018. doi: 10.2196/28018.
Results Reference
derived

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

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