VR for the Reduction of Perioperative Anxiety

NCT06393556 | Completed

• 1 other identifier: VRPERIOP1
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The study, set to take place at Gold Coast University Hospital in Australia, will be conducted as a randomized controlled trial. Patients preparing for gynecological cancer surgery will be recruited and randomly assigned to one of two groups: those who will receive standard care plus a virtual reality (VR) intervention, and those who will receive only standard care. Standard care encompasses the usual pre-operative procedures and support provided by the hospital staff. We hypothesize that immersing patients in a preparatory virtual environment that shows them what they are to expect during their upcoming hospital stay for surgery, could help reduce their anxiety levels.

Conditions

Anxiety State

Keywords

anxiety; virtual reality; gynecologic-oncological surgery

Outcome Measures

Primary Outcomes (1)

• Anxiety

  Anxiety level measured by a 6-item visual scale (1 .. least anxiety, 6 ... highest anxiety)

  T0 (before randomization), T1 (same day as T0, but after care as usual +/- VR; usually inside 1 hour), T2 (days/weeks later, before surgical procedure - exact gap is unknown; expected: >3 days, median around 4-7 weeks)

Study Arms (2)

Virtual reality

EXPERIMENTAL

Care-as-usual + virtual reality intervention during a pre-operative visit

Other: Virtual reality experience

Control

NO INTERVENTION

Care-as-usual during a pre-operative visit

Interventions

Virtual reality experience OTHER

An immersive VR experience, delivered using a VR head-mounted display, of the real-world environment at the hospital, featuring the pre-operative admission suite, pre-anesthetic bay, operating theatre, postoperative recovery room, and medical staff.

Virtual reality

Eligibility Criteria

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

You may qualify if:

• Gynecological oncology patients with scheduled surgery

You may not qualify if:

• Language barrier
• Inability to provide consent
• Having undergone any procedure at the operating theatre in the previous 5 years

Sponsors & Collaborators

• Ruhr University of Bochum: lead
• Gold Coast Hospital and Health Service: collaborator

Study Sites (1)

Gold Coast University Hospital

Southport, Queensland, 4215, Australia

Location

Related Publications (2)

• Cao X, Yumul R, Elvir Lazo OL, Friedman J, Durra O, Zhang X, White PF. A novel visual facial anxiety scale for assessing preoperative anxiety. PLoS One. 2017 Feb 14;12(2):e0171233. doi: 10.1371/journal.pone.0171233. eCollection 2017.

  PMID: 28196099 BACKGROUND

• Schmid BC, Marsland D, Jacobs E, Rezniczek GA. A Preparatory Virtual Reality Experience Reduces Anxiety before Surgery in Gynecologic Oncology Patients: A Randomized Controlled Trial. Cancers (Basel). 2024 May 17;16(10):1913. doi: 10.3390/cancers16101913.

  PMID: 38791991 RESULT

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Bernd C Schmid, MD

  Gold Coast University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Care provider measuring the primary outcome scale at T2 was not aware of the intervention given at T0/1. Statistical data analysis initially was prepared not knowing which group was the intervention group.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Ob/Gyn Research Lab (MHH)

Model Details: 1:1 randomization

Study Record Dates

• First Submitted: April 26, 2024
• First Posted: May 1, 2024
• Study Start: May 10, 2019
• Primary Completion: February 4, 2022
• Study Completion: February 4, 2022
• Last Updated: May 31, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: After publication
• Access Criteria: Reasonable request; approval of intended use by an Institutional Review Board

Locations

AU (1)