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| Name | Class |
|---|---|
| Gateshead Health NHS Foundation Trust | OTHER |
| Queen's University, Belfast | OTHER |
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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Arm : Standard colposcopy care | No Intervention | 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 | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
Staff :
Anyone with a cervix who attends for colposcopy.
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| Name | Affiliation | Role |
|---|---|---|
| Claire McFeeters, BSc PHd | Universtiy of Ulster | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Elizabeth Hospital | Gateshead | Tyne and Wear | NE9 6SX | United Kingdom |
All data will be anonymised so no patient identifiable factors will be included in any publications.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 18, 2024 | Nov 14, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 29, 2023 | Nov 14, 2024 | ICF_001.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 24, 2026 |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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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.
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| Within 15 minutes following the procedure |