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Completed

NCT Number: NCT06693583

Mind Over Cervix: Using Virtual Reality to Reduce Colposcopy Anxiety

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.

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Key information

Conditions

Anxiety Anxiety Disorders Colposcopy Mental Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Queen Elizabeth Hospital

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Anxiety level

    Time frame: Before colposcopy and within 15 minutes after the procedure

    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.

Secondary outcomes

  1. Pain level

    Time frame: Within 15 minutes following the procedure

    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.

Sponsors and collaborators

Lead sponsor

University of Ulster

Other

Collaborators

  • Gateshead Health NHS Foundation Trust
  • Queen's University, Belfast

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 18, 2024
Registry last updated
Nov 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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