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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04579354
Other study ID # EK037/20
Secondary ID CTC-A 20-026
Status Completed
Phase N/A
First received
Last updated
Start date September 7, 2020
Est. completion date January 1, 2021

Study information

Verified date March 2021
Source RWTH Aachen University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 84
Est. completion date January 1, 2021
Est. primary completion date October 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
virtual reality tour
Patients will be guided via VR on their way through the hospital to the operating theater

Locations

Country Name City State
Germany RWTH Aachen University Aachen NRW

Sponsors (1)

Lead Sponsor Collaborator
RWTH Aachen University

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary STOA State T1 Questinaire STOA State T1 before anaesthesia before anaesthesia
Secondary STOA State T2 Questionaire STOA State T2 after anaesthesia within 48 hours after anaesthesia
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