MiscarriageNCT04466956
Virtual Reality in MVA for Miscarriage
A study testing Virtual reality in people with Miscarriage, run by Barts & The London NHS Trust at 2 sites in United Kingdom.
Trial summary
We are investigating the use of a virtual reality programme to reduce pain and anxiety experienced during manual vacuum aspiration. Virtual reality (VR) is the computer-generated simulation of a three-dimensional environment that can be interacted with in a seemingly real way by a person using special electronic… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Miscarriage
- What is being tested?
- Virtual reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 1 Jul 2021to 27 Jan 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients: Clinical indications for undergoing an MVA will be confirmed. Inclusion criteria will include all women of 18 - 50 years of age, planned for a MVA who are able and willing to give informed consent.
Who cannot join
- Hearing impairments and blindness
- History of epilepsy or any previous seizures
- Any known anatomical characteristics that may make performing the office procedure more difficult (e.g., cervical conisation)
- Any known characteristics that make the patient unsuitable for undergoing MVA (e.g. known bleeding disorder, gestation >12 weeks)
- The denial or withdrawal of informed consent
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Whipps Cross University Hospital
London, E11 1NR
North Middlesex University Hospital
London, N18 1QX
About this study
Official title: Virtual Reality as a Distraction Technique for the Management of Acute Pain and Anxiety During Manual Vacuum Aspiration for Miscarriage
We are investigating the use of a virtual reality programme to reduce pain and anxiety experienced during manual vacuum aspiration.
Virtual reality (VR) is the computer-generated simulation of a three-dimensional environment that can be interacted with in a seemingly real way by a person using special electronic equipment. In this study a VR headset is worn by the patient allowing them to experience a relaxing environment whilst the procedure manual vacuum aspiration (MVA) is performed.
VR is mostly used in computer gaming but has uses in medical field and has been used in the treatment of long standing pain, treatment of burns, dentistry and treatment of cancer pain. However, its role in the management of pain and anxiety during gynaecological procedures like manual vacuum aspiration has not been researched. This study explores whether it has a place in the treatment of gynaecological pain and reduction of anxiety.
Read the detailed description
Many simple gynaecological procedures can be performed in an outpatient setting without the need for general anaesthesia. Such office-based procedures include outpatient hysteroscopy, endometrial biopsy, large-loop-excision of the transformation zone and manual vacuum aspiration for the management of miscarriage. Advantages experienced by patients include reduced anaesthetic risk, enhanced recovery time and flexibility of timings. For the healthcare provider there are significant cost benefits on the basis of reduced theatre time, staff and equipment. Patient satisfaction is generally high but influenced by their experience of pain and feelings of anxiety before, during and after the procedure.
The rationale for this study is to invetsigate the role of distraction techniques and the feasibility of using virtual reality for the management of acute pain and anxiety experienced by patients undergoing manual vacuum aspiration
Primary objective
- Feasibility of using virtual reality as a distraction technique in management of acute pain and anxiety in patients undergoing manual vacuum aspiration for miscarriage.
Secondary objectives
- Understanding the acceptability and effectiveness of VR interventions in office gynaecology procedures
- Understanding the factors that might influence the willingness of patients to participate in a future formal trial of the technology.
- Understanding how best to implement the technology and designing of the contents of the VR intervention.
- Conditions
- Miscarriage
- Being tested
- Virtual reality
- Keywords
- Management, Anxiety, Pain
- Medical subject headings
- Abortion, Spontaneous, Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual realityDevice
Virtual reality headset worn with short relaxing video played during MVA procedure
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality for reduction of pain and anxiety during MVA | Active comparator | 25 participants randomised to use VR headset during MVA and complete questionnaire and short interview regarding experience Receives: Device: Virtual reality |
| Control group- no VR | No intervention | 25 participants randomised to not use VR headset during MVA and complete questionnaire and short interview regarding experience |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety Rating
Anxiety score (numerical rating score 0 least-10 worst) and questionnaire
Measured: 12 months
Pain Rating
Pain score (numerical rating score 0 least-10 worst) and questionnaire
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2020
- Study start1 Jul 2021
- Primary completion1 Jul 2022
- Study completion27 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MiscarriageStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention 25 and control 25
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barts & The London NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- North Middlesex University Hospital NHS Trust
- Responsible party
- Sponsor
- Investigators
- Nandita Deo, MRCOG, Principal investigator, Barts & The London NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04466956
- Sponsor's protocol ID
- 271029
- Status last verified
- Nov 2024
- First submitted
- 7 Jul 2020
- Last updated
- 25 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Plan to publish results
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality as a Distraction Technique for the Management of Acute Pain and Anxiety During Manual Vacuum Aspiration for Miscarriage
- ClinicalTrials.gov ID
- NCT04466956
- Acronym / sponsor ID
- 271029
- Conditions
- Miscarriage
- Keywords
- Management, Anxiety, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Collaborators
- North Middlesex University Hospital NHS Trust
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 27 Jan 2023 (actual)
- First posted
- 10 Jul 2020 (actual)
- Results
- Posted 25 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We are investigating the use of a virtual reality programme to reduce pain and anxiety experienced during manual vacuum aspiration.
Virtual reality (VR) is the computer-generated simulation of a three-dimensional environment that can be interacted with in a seemingly real way by a person using special electronic equipment. In this study a VR headset is worn by the patient allowing them to experience a relaxing environment whilst the procedure manual vacuum aspiration (MVA) is performed.
VR is mostly used in computer gaming but has uses in medical field and has been used in the treatment of long standing pain, treatment of burns, dentistry and treatment of cancer pain. However, its role in the management of pain and anxiety during gynaecological procedures like manual vacuum aspiration has not been researched. This study explores whether it has a place in the treatment of gynaecological pain and reduction of anxiety.
Detailed description
Many simple gynaecological procedures can be performed in an outpatient setting without the need for general anaesthesia. Such office-based procedures include outpatient hysteroscopy, endometrial biopsy, large-loop-excision of the transformation zone and manual vacuum aspiration for the management of miscarriage. Advantages experienced by patients include reduced anaesthetic risk, enhanced recovery time and flexibility of timings. For the healthcare provider there are significant cost benefits on the basis of reduced theatre time, staff and equipment. Patient satisfaction is generally high but influenced by their experience of pain and feelings of anxiety before, during and after the procedure.
The rationale for this study is to invetsigate the role of distraction techniques and the feasibility of using virtual reality for the management of acute pain and anxiety experienced by patients undergoing manual vacuum aspiration
Primary objective
- Feasibility of using virtual reality as a distraction technique in management of acute pain and anxiety in patients undergoing manual vacuum aspiration for miscarriage.
Secondary objectives
- Understanding the acceptability and effectiveness of VR interventions in office gynaecology procedures
- Understanding the factors that might influence the willingness of patients to participate in a future formal trial of the technology.
- Understanding how best to implement the technology and designing of the contents of the VR intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intervention 25 and control 25
| Arm | Type | Receives |
|---|---|---|
| Virtual reality for reduction of pain and anxiety during MVA | Active comparator | Device: Virtual reality25 participants randomised to use VR headset during MVA and complete questionnaire and short interview regarding experience |
| Control group- no VR | No intervention | –25 participants randomised to not use VR headset during MVA and complete questionnaire and short interview regarding experience |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients: Clinical indications for undergoing an MVA will be confirmed. Inclusion criteria will include all women of 18 - 50 years of age, planned for a MVA who are able and willing to give informed consent.
Key exclusion criteria (5 listed)
- Hearing impairments and blindness
- History of epilepsy or any previous seizures
- Any known anatomical characteristics that may make performing the office procedure more difficult (e.g., cervical conisation)
- Any known characteristics that make the patient unsuitable for undergoing MVA (e.g. known bleeding disorder, gestation >12 weeks)
- The denial or withdrawal of informed consent
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 realityVirtual reality headset worn with short relaxing video played during MVA procedure | Device | Virtual reality for reduction of pain and anxiety during MVA |
Primary outcome
Anxiety Rating
Time frame: 12 months
Anxiety score (numerical rating score 0 least-10 worst) and questionnaire
Pain Rating
Time frame: 12 months
Pain score (numerical rating score 0 least-10 worst) and questionnaire
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Plan to publish results
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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.
Nandita Deo, MRCOG principal investigator
Barts & The London NHS Trust
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality in people with Miscarriage, run by Barts & The London NHS Trust at 2 sites 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 1 inclusion and 5 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 25 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 2 sites 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?
Yes. Results are posted in the registry (first posted 25 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Rating (time frame: 12 months). The study lists 2 primary outcomes in all. 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 25 Nov 2024.