Anxiety, Colposcopy
Conditions
Keywords
Colposcopy, Anxiety Reduction, Cervical screening, Virtual Reality, Pain reduction
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.
Interventions
DEVICEVirtual 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.
Sponsors
Gateshead Health NHS Foundation Trust
Queen's University, Belfast
University of Ulster
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety level | 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
| Measure | Time frame | Description |
|---|---|---|
| Pain level | 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. |
Countries
United Kingdom
Outcome results
None listed