Clinical trial NCT06693583: Mind Over Cervix: Using Virtual Reality to Reduce Colposcopy Anxiety
Official title: VR as a Distraction Technique for Management of Acute Anxiety and Pain During Outpatient Colposcopy Procedures - a Single Centre Randomised Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Colposcopy
Keywords: Colposcopy
Anxiety Reduction
Cervical screening
Virtual Reality
Pain reduction
Lead sponsor: University of Ulster
Sponsor class: OTHER
Collaborators: name: Gateshead Health NHS Foundation Trust
name: Queen's University, Belfast
First posted: 2024-11-18
Enrollment: 141
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Anxiety level
timeFrame: Before colposcopy and within 15 minutes after the procedure
Secondary outcomes:
measure: Pain level
timeFrame: Within 15 minutes following the procedure
Other outcomes:
Locations:
city: Gateshead
country: United Kingdom
facility: Queen Elizabeth Hospital
state: Tyne And Wear
Study officials:
affiliation: Universtiy of Ulster
name: Claire McFeeters, BSc PHd
role: STUDY_CHAIR
References: