Mind Over Cervix: Using Virtual Reality to Reduce Colposcopy Anxiety

VR as a Distraction Technique for Management of Acute Anxiety and Pain During Outpatient Colposcopy Procedures - a Single Centre Randomised Control Trial

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.

Study Overview

• Status: Completed
• Conditions: Anxiety; Colposcopy
• Intervention / Treatment: Device: Virtual Reality Headsets

• Study Type: Interventional
• Enrollment (Actual): 141
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Tyne And Wear
    • Gateshead, Tyne And Wear, United Kingdom, NE9 6SX
      • Queen Elizabeth Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: 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.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain level	A numerical rating score from 0-10 will be assess following the procedure for both maximum pain felt and average pain felt. Participants will be asked following the colposcopy to rate both the "maximum pain felt, if even for a second," and "average pain felt." This will be measured using a validated Likert scale from 0-10 with 0 indicated no pain, and 10 indicating the worst pain ever felt.	Within 15 minutes following the procedure

Collaborators and Investigators

• Sponsor: University of Ulster
• Collaborators: Queen's University, Belfast; Gateshead Health NHS Foundation Trust
• Investigators: Study Chair: Claire McFeeters, BSc PHd, Universtiy of Ulster

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2024
• Primary Completion (Actual): August 9, 2024
• Study Completion (Actual): August 22, 2024

Study Registration Dates

• First Submitted: February 2, 2024
• First Submitted That Met QC Criteria: November 14, 2024
• First Posted (Estimated): November 18, 2024

Study Record Updates

• Last Update Posted (Estimated): November 18, 2024
• Last Update Submitted That Met QC Criteria: November 14, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Virtual Reality; Colposcopy; Pain reduction; Cervical screening; Anxiety Reduction
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: FCNUR-23-098

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: All data will be anonymised so no patient identifiable factors will be included in any publications.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No