AnxietyNCT06693583
Mind Over Cervix: Using Virtual Reality to Reduce Colposcopy Anxiety
A study testing Virtual Reality Headsets in people with Anxiety and Colposcopy, run by University of Ulster at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anxiety, Colposcopy
- What is being tested?
- Virtual Reality Headsets
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 May 2024to 22 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United Kingdom1 site
Queen Elizabeth Hospital
Gateshead, Tyne and Wear, NE9 6SX
About this study
Official title: VR as a Distraction Technique for Management of Acute Anxiety and Pain During Outpatient Colposcopy Procedures - a Single Centre Randomised Control Trial
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:
Read more
- 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.
- Conditions
- Anxiety, Colposcopy
- Being tested
- Virtual Reality Headsets
- Keywords
- Colposcopy, Anxiety Reduction, Cervical screening, Virtual Reality, Pain reduction
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality HeadsetsDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Virtual Reality Headsets |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before colposcopy and within 15 minutes after the procedure
Secondary outcomes (1)
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.
Measured: Within 15 minutes following the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2024
- Study start22 May 2024
- Primary completion9 Aug 2024
- Study completion22 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulster
- Sponsor type
- University, hospital or other
- Collaborators
- Gateshead Health NHS Foundation Trust, Queen's University, Belfast
- Responsible party
- Sponsor
- Investigators
- Claire McFeeters, BSc PHd, Study chair, Universtiy of Ulster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06693583
- Sponsor's protocol ID
- FCNUR-23-098
- Status last verified
- Nov 2024
- First submitted
- 2 Feb 2024
- Last updated
- 18 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data will be anonymised so no patient identifiable factors will be included in any publications.
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VR as a Distraction Technique for Management of Acute Anxiety and Pain During Outpatient Colposcopy Procedures - a Single Centre Randomised Control Trial
- ClinicalTrials.gov ID
- NCT06693583
- Acronym / sponsor ID
- FCNUR-23-098
- Conditions
- Anxiety, Colposcopy
- Keywords
- Colposcopy, Anxiety Reduction, Cervical screening, Virtual Reality, Pain reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- University of UlsterUniversity, hospital or other
- Collaborators
- Gateshead Health NHS Foundation Trust, Queen's University, Belfast
- Study start
- 22 May 2024 (actual)
- Primary completion
- 9 Aug 2024 (actual)
- Study completion
- 22 Aug 2024 (actual)
- First posted
- 18 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: Virtual Reality HeadsetsThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality HeadsetsVirtual 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. | Device | Virtual reality headsets as a distraction method |
Primary outcome
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.
1 secondary outcome
Pain level
Time frame: Within 15 minutes following the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
- Individual participant dataSharing planned: No. All data will be anonymised so no patient identifiable factors will be included in any publications.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claire McFeeters, BSc PHd study chair
Universtiy of Ulster
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Headsets in people with Anxiety and Colposcopy, run by University of Ulster at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety level (time frame: Before colposcopy and within 15 minutes after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2024.