Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05307887 |
| Other study ID # |
21SM7296 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 26, 2022 |
| Est. completion date |
October 2022 |
Study information
| Verified date |
August 2022 |
| Source |
Imperial College Healthcare NHS Trust |
| Contact |
Thomas Sewell |
| Phone |
02033122152 |
| Email |
thomas.sewell2[@]nhs.net |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Hysteroscopy is a common procedure where a camera attached to a thin scope is passed into the
uterus via the vagina and cervix in order to obtain views of the inside of the uterus.
Hysteroscopy is used for the diagnosis and management of a variety of benign and conditions
as well as the diagnosis of uterine cancer. It can be performed under general anaesthetic or
in an outpatient setting without formal anaesthetic. The latter has several advantages when
compared to hysteroscopy with general anaesthesia as it avoids the additional risk of general
anaesthesia, has a quicker recovery time, shorter hospital stay and reduced cost. However,
women may experience discomfort or pain during an outpatient procedure and pain is one of the
most common reasons for failure to complete the procedure.
The most appropriate way to manage pain and anxiety during outpatient hysteroscopy is not yet
fully understood and conventional therapy, as recommended by the Royal College of
Obstetricians and Gynaecologists, involves the use of simple pain killers taken prior to the
procedure and sometimes local anaesthetic during the procedure. In recent years virtual
reality software has been developed and used in a variety of different settings to alleviate
pain and anxiety during medical procedures.
This study aims to investigate whether the use of virtual reality as an adjunct to
conventional pain management can reduce anxiety and pain during outpatient hysteroscopy. The
study will take the form of a randomised controlled trial at St Mary's hospital London. A
randomly selected group of patients undergoing outpatient hysteroscopy with conventional
management plus the addition of virtual reality software will be compared to a control group
of patients undergoing the procedure with conventional management only.
Description:
BACKGROUND
Hysteroscopy is a very common gynaecological procedure where a camera attached to a thin
scope is passed into the uterus via the vagina and cervix in order to obtain views of the
inside of the uterus. Hysteroscopy is used for the diagnosis and management of a variety of
benign and conditions as well as the diagnosis of uterine cancer. It can be performed under
general anaesthetic or in an outpatient setting without formal anaesthetic. The latter has
several advantages when compared to hysteroscopy with general anaesthesia as it avoids the
additional risk of general anaesthesia, has a quicker recovery time, shorter hospital stay
and reduced cost. Outpatient hysteroscopy (OPH) is generally well tolerated although some
women will experience significant pain and pain is one of the most common reasons for failure
to complete the procedure.
As pain is one of the leading reasons for procedure failure, finding ways to reduce pain and
anxiety is of critical importance. The optimal method of controlling pain and anxiety during
outpatient hysteroscopy is poorly understood and hotly debated. Options include sedation,
local anaesthetic, analgesics including paracetamol, non-steroidal anti-inflammatory
medication, opioids, Entonox and various distraction techniques. There is a wide variation of
clinical practice between different units within the UK due to a paucity of good quality
evidence informing best practice. Conventional therapy, as recommended by the Royal College
of Obstetricians and Gynaecologists, involves the use of simple pain killers taken prior to
the procedure and sometimes local anaesthetic during the procedure if dilatation of the
cervix is required (RCOG 2011).
Virtual reality (VR) technology is a relatively new and promising technology which if used as
a distraction technique, may be able to reduce pain and anxiety experienced from a wide range
of medical procedures. Virtual reality (VR) is a human-computer interface that provides users
with various physical sensations (e.g., visual, haptic, auditory) to increase realism in the
virtual world (Seth et al. 2011). This heightened sense of realism produces a phenomenon
known as "presence," which refers to the user's authentic experience of being in the virtual
world as a result of visual or auditory displays generated by a computer (Barfield and
Hendrix 1995). VR's ability to provide users with highly realistic immersive experiences can
be used to for a variety of medical indications including distraction from uncomfortable or
painful procedures.
To date VR has been used in a wide variety of inpatient and outpatient clinical scenarios to
reduce pain and anxiety including simple blood tests, ENT procedures and minor gynaecological
procedures such as hysterosalpingograms (Chan et al 2018, Wang et al 2020 and Ahmadpoura et
al 2019). However, currently, to the best of our knowledge, there is only one relatively
small-scale trial investigating the use of VR in an outpatient hysteroscopy setting (Deo et
al 2020) meaning further studies are urgently needed to clarify the situation.
RATIONALE FOR CURRENT STUDY
The purpose of this study would be to determine if the use of VR technology can reduce pain
and anxiety experienced by patients during outpatient hysteroscopy procedures when compared
to standard pain management.
The optimal method of controlling pain and anxiety during outpatient hysteroscopy is poorly
understood and there is a wide variation in clinical practice. This study aims to test
whether VR technology could reduce pain and anxiety as a relatively simple and safe adjunct
to conventional pain management. Although VR has been used in a variety of clinical settings
to date, there is only one previous study investigating the use of VR in an outpatient
hysteroscopy setting (Deo et al 2020). This existing trial established that the use of VR is
feasible in the OPH setting and that it was effective with significant improvements in
patient reported anxiety and pain scores compared to conventional pain management. However,
as the authors themselves acknowledge, it involved relatively small numbers (20 patients in
control and intervention group respectively). The rationale of this study would be to build
upon this evidence by performing the first large scale adequately powered randomised control
trial of the use of VR technology in this setting.
The study team hypothesises that the use of VR technology will significantly improve pain and
anxiety when compared to conventional pain management. Finding additional low risk ways of
improving pain and anxiety during OPH is of critical importance in order to improve patient
experience and the success rate of the procedure as pain is a major reason for unsuccessful
OPH procedures.
2. STUDY OBJECTIVES
The primary objectives of this study are to determine if:
1. VR technology can reduce pain during outpatient hysteroscopy?
2. VR technology can reduce anxiety during outpatient hysteroscopy?
The secondary objectives of this study are to determine if:
1. The use of VR technology feasible during outpatient hysteroscopy?
2. The use of VR during outpatient hysteroscopy reduces the procedure failure rate?
3. The use of VR increases the outpatient hysteroscopy appointment time?
STUDY DESIGN
The study design is an unblinded randomised controlled trial. This study design was chosen as
it will provide the best quality of evidence with reduced bias compared to other study
designs. A randomised controlled trial is also very feasible in this scenario. Neither the
researchers nor the participants will be blinded as to which study arm they are in, as it
would be impractical to do so with a VR headset used in the intervention group. The study
will be adequately powered with a power calculation based upon findings from previous
studies, meaning at least 40 patients will be included in each arm (at least 80 patients in
total).
Patients will be randomly allocated by computer allocation to either the intervention or the
control group. The intervention group will undergo OPH with standard care plus the use of VR
technology administered through a headset with the option of wearing headphones (at the
patient's discretion) or having the accompanying sound played aloud. The control group will
undergo outpatient hysteroscopy with standard care. Standard care in this unit is in line
with the RGCOG guidelines and involves advising patients to take ibuprofen and/or paracetamol
one hour prior to their procedure unless there are contraindications. Local anaesthetic
intracervical block is used at the discretion of the operator and is usually used if
dilatation of the cervix is required.
The primary outcome measure will be the reported NRS (numeric rating score) score which is
validated score to assess pain and anxiety levels with values from 0-11. The patient will be
asked to fill out the NRS score prior to the hysteroscopy and following the hysteroscopy
prior to leaving the clinic.
Secondary outcome measures will be length of procedure, complication rate, reported side
effects, procedure completion, hysteroscopy findings and type of procedure performed (for
example if purely diagnostic or if any operative procedures are performed).
Participants will be recruited from the general gynaecology clinics. Only patients who have
already opted to undergo outpatient hysteroscopy will be invited to take part in the study
and they will be made aware of the study at the time of the clinic appointment or shortly
after. Interested parties will then be contacted by the research team to discuss the study in
more detail at a time which is convenient for the patient. Written consent to enter the study
will be sought from the participant in advance of their procedure and only after a full
explanation has been given. The patient will be offered a study information leaflet. Whilst
waiting for their hysteroscopy procedure, the patient will be offered a face-to-face
appointment with a member of the research team to discuss the study and sign the written
consent form if they wish to participate in the study. If it is more convenient for the
patient, and to avoid unnecessary additional appointments for the patient, they may prefer to
discuss the study and go through the consent by phone before confirming consent on the day of
the procedure. Patients will have time to consider whether to take part in the study prior to
their procedure day and will be informed that they can withdraw consent for participation in
the study at any time. Participating or not participating in the study will have no effect on
the timing of the outpatient hysteroscopy or the type of procedure performed. Patients will
have the opportunity to choose which virtual reality scenario they wish to experience during
the procedure (choice of 4 scenarios from beach, space, underwater and zen four seasons).
At the time of their hysteroscopy. The patient will fill out the pre-procedure NRS score
prior to entering the hysteroscopy room. The patient will then enter the outpatient
hysteroscopy room where there will be the hysteroscopy team consisting of the lead
hysteroscopist and the assistant, and also a single member of the research team who will have
taken the study consent from the patient prior to their procedure. Following discussion with
the hysteroscopist as usual, the patient will prepare for the procedure and position
themselves on the procedure couch. Once comfortable, the member of the research team will
help the patient to put on the VR headset (See appendix 1), and if the patient wishes,
headphones. The virtual reality software will then start running and is controlled by the
research team member, the software will run for the length of the procedure. The hysteroscopy
team will be preparing the equipment as the virtual reality software is running. The member
of the research team will remain in the room throughout the procedure to troubleshoot any
issues with the headset or software and if necessary to stop the VR program. Following
completion of the procedure the patient will fill out a NRS score prior to going home.
The VR software involves breathing exercises, relaxing music and a distracting immersive walk
through a virtual environment. The scenario will be started and subsequently controlled by a
member of the research team operating a tablet device. The hysteroscopy team will perform the
procedure in exactly the same way as they would normally and any clinical decisions regarding
potential procedures such as polypectomy, discontinuing or proceeding with the hysteroscopy
will be made by the hysteroscopy team along with the patient in the usual way without any
input from the research team member.
Maintaining appropriate clinical hygiene is of critical importance as the same headset will
be used for different patients. The headset can be easily and effectively cleaned between use
and the manufacturer (VR medical) provides a recommended cleaning regimen which we will use
for the trial. After use, the VR device and controller should be cleaned with a damp
microfibre cloth and disinfectant wipe, both the parts that have been in contact with the
skin and the headbands.
The timetable for the project is expected to run as follows. Three months for preparation and
obtaining ethical approval. Recruitment is expected to start following this and we would
expect to obtain the required number of participants by 3 months based on the average
referral rate for outpatient hysteroscopy in the unit being 150 patients per month and a 20%
study participation rate. Data analysis and preparing the final report would take a further 3
months.
Results will be recorded onto a pseudoanonymised database. Information will be collected from
patients notes and imaging reports. Each patient will be allocated a study number and for
each the following will be recorded:
Age Parity Symptoms and duration Past medical history and co-morbidities BMI Previous surgery
Current medication and medication used within the last 6 months Pain NRS (numeric rating
score) Anxiety NRS Length of hysteroscopy procedure Time in Outpatient Procedure room
Procedure successfully completed (or not) and reason for failure if appropriate Complications
Hysteroscopy findings Type of hysteroscopic procedure performed
STUDY OUTCOME MEASURES
The primary outcome measure will be the reported NRS (numeric rating score) score which is
validated score to assess pain and anxiety levels with values from 0-11. The patient will be
asked to fill out the NRS score prior to the hysteroscopy and following the hysteroscopy
prior to leaving the clinic.
Secondary outcome measures will be length of procedure, complication rate, reported side
effects, procedure completion, hysteroscopy findings and type of procedure performed (for
example if purely diagnostic or if any operative procedures are performed).
