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

NCT04579354 | Completed

• 2 other identifiers: EK037/20CTC-A 20-026
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Anaesthesia; Anxiety; Postoperative Pain

Keywords

virtual reality (VR); anxiety preoperative; opearting theater

Outcome Measures

Primary Outcomes (1)

• STOA State T1

  Questinaire STOA State T1 before anaesthesia

  before anaesthesia

Secondary Outcomes (1)

• STOA State T2

  within 48 hours after anaesthesia

Study Arms (2)

Standardized Anaesthesia briefing

NO INTERVENTION

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.

Virtual reality (VR) tour

EXPERIMENTAL

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

Interventions

virtual reality tour OTHER

Patients will be guided via VR on their way through the hospital to the operating theater

Virtual reality (VR) tour

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

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

Sponsors & Collaborators

• RWTH Aachen University: lead

Study Sites (1)

RWTH Aachen University

Aachen, North Rhine-Westphalia, 52074, Germany

Location

Related Publications (1)

• 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.

  PMID: 34252034 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Pain, Postoperative

Condition Hierarchy (Ancestors)

Mental Disorders; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2020
• First Posted: October 8, 2020
• Study Start: September 7, 2020
• Primary Completion: October 30, 2020
• Study Completion: January 1, 2021
• Last Updated: March 15, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)