Mind Over Cervix: Using Virtual Reality to Reduce Colposcopy Anxiety

NCT06693583 | Completed

• 1 other identifier: FCNUR-23-098
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 1

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

Keywords

Colposcopy; Anxiety Reduction; Cervical screening; Virtual Reality; Pain reduction

Outcome Measures

Primary Outcomes (1)

• Anxiety level

  Modified State Trait Anxiety Index scores (STAI) will be assessed both prior to colposcopy and afterwards. STAI scores is a validated questionaire for measurement of anxiety. It consists of 5 questions with participants self reporting scores. Questions include "I feel frightened," "I feel jittery," " I feel upset," "I feel nervous" and "I feel confused." Outcomes include "Not at all," "Somewhat," "Moderately so" and "very much so." These are scored 1 -4. Total scores will range from 5 to 20, with high scores indicating a higher state of anxiety.

  Before colposcopy and within 15 minutes after the procedure

Secondary Outcomes (1)

• Pain level

  Within 15 minutes following the procedure

Study Arms (2)

Control Arm : Standard colposcopy care

NO INTERVENTION

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.

Virtual reality headsets as a distraction method

EXPERIMENTAL

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.

Device: Virtual Reality Headsets

Interventions

Virtual Reality Headsets 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.

Virtual reality headsets as a distraction method

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Anyone with a cervix who attends for colposcopy.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Ulster: lead
• Gateshead Health NHS Foundation Trust: collaborator
• Queen's University, Belfast: collaborator

Study Sites (1)

Queen Elizabeth Hospital

Gateshead, Tyne and Wear, NE9 6SX, United Kingdom

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Claire McFeeters, BSc PHd

  Universtiy of Ulster

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Participants will be blindly randomly allocation to the control or intervention arm, however due to the nature of the study it will not be possible to blind the participant or assessor.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2024
• First Posted: November 18, 2024
• Study Start: May 22, 2024
• Primary Completion: August 9, 2024
• Study Completion: August 22, 2024
• Last Updated: November 18, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)