Mind Over Cervix: Using Virtual Reality to Reduce Colposcopy Anxiety

Ulster University

Status: Completed

Conditions: Colposcopy; Anxiety

Treatments: Device: Virtual Reality Headsets

Study type: Interventional

Funder types: Other

Identifiers

NCT06693583

FCNUR-23-098

Details and patient eligibility

About

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.

Enrollment: 141 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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141 participants in 2 patient groups

Control Arm : Standard colposcopy care

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Device: Virtual Reality Headsets