Mind Over Cervix: Using Virtual Reality to Reduce Colposcopy Anxiety

NCT ID: NCT06693583

Last Updated: 2024-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 141 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-22
• Study Completion Date: 2024-08-22

Brief Summary

Colposcopy is an extremely important part of womens healthcare in the prevention of cervical cancer. Women report feeling extremely anxious attending colposcopy, due to the association with cancer and the intimate nature of the examination.

The goal of this clinical trial is to investigate where the use of virtual reality headsets during outpatient colposcopy appointments has any effect on womens' experience. The main question[s] it aims to answer are:

• Does the use of virtual reality headsets reduce anxiety in patients attending colposcopy
• Does the use of virtual reality headsets reduce pain in patients attending colposcopy

Patients will offered to enroll in the trial when they attend for their colposcopy appointment.

Participants will fill out a questionnaire to measure their anxiety beforehand and collect patient demographics.

They will be randomly allocated into the intervention arm or the control arm. This means they will either use virtual reality headset in addition to the standard care, or have standard colposcopy care only After their colposcopy, they will then be asked to to fill out another questionnaire to measure anxiety and pain levels.

If there is a comparison group: Researchers will compare the results from the women who had colposcopy while using the virtual reality headsets to women to see if there is any meaningful difference in anxiety while using the virtual reality headsets.

Conditions

Anxiety; Colposcopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Control Arm : Standard colposcopy care

Women in the control arm will be offered all aspects of standard colposcopy care for their pain relief. This includes : nursing support, local anaesthetic and gas and air as required.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Virtual reality headsets as a distraction method

The patient will attend for colposcopy at which the consultation will begin as normal. When the time comes for examination +/- biopsy +/- treatment, the patient will be offered the virtual reality headset as a form of immersive therapy to distract them during the procedure. This will be continued until cessation of examination. All other standard forms of pain relief will also be provided for the patient.

Group Type: EXPERIMENTAL

Virtual Reality Headsets

Intervention Type: DEVICE

Virtual reality (VR) headsets are used as a form of distraction technique widely throughout healthcare. Women will be assisted to apply the VR prior to their colposcopy examination beginning. They will be shown an immersive video of walking through a forest that reminds them to breath deeply. The aim is that this will relax them during the colposcopy examination.

Interventions

Virtual Reality Headsets

Virtual reality (VR) headsets are used as a form of distraction technique widely throughout healthcare. Women will be assisted to apply the VR prior to their colposcopy examination beginning. They will be shown an immersive video of walking through a forest that reminds them to breath deeply. The aim is that this will relax them during the colposcopy examination.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patients
• women over 18 years of age who attend for outpatient colposcopy and provide informed written consent
• Staff
• Have completed colposcopy training and be a registered member of the British Society of Colposcopy and Cervical Pathology (BSCCP)
• Informed written consent to take part in the trial.

Exclusion Criteria

• Patients :
• Significant hearing or visual impairments that may effect communication
• Any known characteristics that may make the office procedure more difficult (eg. previous LLETZ, previous cervical conisation, uterine didelphis)
• Inability to provide consent.
• Denial or withdrawal of informed consent orally

Staff :

• The denial or withdrawal of informed consent.
• Trainee colposcopist performing clinic.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Gateshead Health NHS Foundation Trust

OTHER

Sponsor Role: collaborator

Queen's University, Belfast

OTHER

Sponsor Role: collaborator

University of Ulster

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Claire McFeeters, BSc PHd

Role: STUDY_CHAIR

Universtiy of Ulster

Locations

Queen Elizabeth Hospital

Gateshead, Tyne and Wear, United Kingdom

Countries

United Kingdom

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

FCNUR-23-098

Identifier Type: -

Identifier Source: org_study_id