Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03699280 |
| Other study ID # |
18IC4481 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 4, 2018 |
| Est. completion date |
October 6, 2018 |
Study information
| Verified date |
May 2022 |
| Source |
Imperial College London |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
TITLE Virtual Reality (VR) as a Distraction technique for management of acute pain at
Outpatient Hysteroscopy DESIGN Randomised Control Trial (RCT) with Mixed methods -
Qualitative and quantitative AIMS To study the role of distraction techniques for management
of acute pain in Outpatient Hysteroscopy and to assess feasibility of using Virtual Reality
for managing pain.
Primary objective:
• Feasibility of using virtual reality as a distraction technique in management of acute pain
in patients undergoing Outpatient Hysteroscopy.
Secondary objectives:
- Understanding the acceptability and effectiveness of VR interventions within the
procedural groups and how these might vary as a function of different patient
demographics.
- 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.
- Understanding the effective mechanisms for the analgesic effect of VR and explore how
this could be tailored to individual patients.
POPULATION Patients attending the Outpatient Hysteroscopy clinics ELIGIBILITY Patients
undergoing Outpatient Hysteroscopy DURATION 6 months
Description:
INTRODUCTION
BACKGROUND Performing procedures for investigation and treatment of gynaecological conditions
in the office setting is becoming commonplace. Outpatient gynaecological procedures can
reduce risks of general anaesthetic, decrease health care costs and make the procedure more
convenient for the patient and provider. However, ensuring adequate pain relief and allaying
anxiety during the procedure can prove to be challenging. Appropriate patient selection,
counselling and adequate pain management during the procedure can improve patient experience
and reduce the number of failed procedures.
Common office gynaecological procedures include outpatient hysteroscopy, colposcopy and large
loop excision of transformation zone, manual vacuum aspiration for treatment of miscarriages,
intrauterine contraceptive device insertion, hysteroscopic sterilisation and endometrial
biopsy.
Pain in gynaecological procedures can originate from the cervix and uterus. The uterine
fundus is innervated by sympathetic fibres from T10 to L2, which enter through the
uterosacral ligaments via the inferior hypogastric plexus, and by nerves from the ovarian
plexuses at the cornua. Parasympathetic fibres from S2 to S4 travel through the broad
ligament to enter the cervix at the 3 0 clock and 9 o clock positions to provide innervation
to the upper vagina, cervix and the lower uterine segment. The pudendal nerve (S 2,3, 4)
supplies the lower vagina and vulva.
Physical, psychological and social factors influence the intensity of pain experienced.
Counselling the patients pre procedurally helps to better manage expectations and pain.
Outpatient hysteroscopy is usually performed for patients having abnormal uterine bleeding
and subfertility. Pain levels during this procedure can be influenced by the diameter of the
hysteroscope. Mini hysteroscopes with an outer diameter of 3.5 mm have been associated with
lower pain scores. Additional procedures performed (like polypectomy or Coil insertions)
could increase the duration of the procedure and the pain experienced during the procedure.
Pain scores in the vaginoscopic approach have been noted to be 3.8 when compared to 5.3 in
the traditional group, which uses a speculum and tenaculum.
Pain in hysteroscopy is significantly related to the presence of cervical synechiae, to the
duration of the procedure, and to the use of normal saline; conversely, parity seems to have
a protective role.
Previous vaginal deliveries, experience of the operator and quicker operative time are known
to be associated with successful outcomes of the outpatient procedures. However, nulliparity,
postmenopausal status, anxiety and anticipated pain and a history of dsymenorrhoea are known
to be associated with higher perception of pain and reduced success rates.
The type of pain relief offered can include various levels of sedation, local anaesthetic,
analgesics and verbal support techniques through distraction by conversation, gentle
language, music, guided imagery and positive suggestion. A Cochrane Review showed no
consistent good quality evidence of a significant difference in safety or effectiveness
between different types of pain relief compared with each other or with placebo/ no
treatment. There is no consensus on the choice of analgesia for outpatient hysteroscopy and
rescue analgesia in the form of intracervical blocks is often used.
In the United Kingdom, most units offer analgesics either as Non Steroidal Anti Inflammatory
Drugs (NSAIDs), acetaminophen or oral opiods. NSAIDS such as ibuprofen decrease uterine
activity and pain by inhibiting cyclooxygenase and thereby reduce circulating prostaglandins.
They reduce pain levels especially postoperatively. Acetaminophen also inhibits the enzyme
cyclooxygenase, but its action is in the central nervous system rather in the periphery.
Hence is inferior to NSAIDS but is offered to women who cannot tolerate NSAIDS. Oral opiods
act by interacting with endogenous opioid mu receptors.
The only pharmacological method that has demonstrated its effectiveness in reducing pain
during and 30 minutes after hysteroscopy in several meta-analysis and reviews is paracervical
block. However, it fails to anaesthetise the uterus for intrauterine procedures and a
previous Cochrane review was unable to confirm this. The administration of the local
anaesthetic itself may be uncomfortable, have side effects due to toxicity, may cancel the
beneficial effect of performing a vaginoscopic hysteroscopy and does not anaesthetise the
uterus. Addition of soda bicarbonate as a buffering agent to the local anaesthetic and using
dental syringes with a 27-gauge needle has been seen to decrease the pain during the
injection. Topical local anaesthetics on the cervix in the form of gel or sprays have not
been shown to be effective.
Women undergoing outpatient hysteroscopy experience significant levels of preoperative
anxiety which is higher than patients attending the gynaecology clinic and comparable to
those experienced before major surgery under general anaesthesia.
Anxiolytics help reduce anxiety, however they do not have a direct analgesic effect.
Units often employ a trained person to engage with the patient to provide emotional support
during the procedure.
Distraction Techniques Type of distraction techniques range from active distraction
techniques to passive techniques. Active distraction included interactive toys, virtual
reality, guided imagery and relaxation and controlled breathing. Passive distraction
techniques included auditory distraction in the form of music and audio-visual distraction
through watching television. Intraoperative pain and anxiety rating have been noted to be
lower by use of simple intraoperative distraction techniques e.g. interacting with nurses,
watching Digital Video Discs or using stress balls.
There has been limited research done on the role of distraction techniques in pain management
in outpatient gynaecological procedures. Music has been used as a complementary method to
control anxiety and reduce perception of pain by relaxing the patient and causing less
discomfort during outpatient hysteroscopy. . However, a RCT showed no positive effect of
music on patients' level of pain, anxiety or satisfaction of patient or doctor for office
hysteroscopy and colposcopy. Watching the procedure on the screen at office hysteroscopy has
not been shown to reduce pain scores.
Women with high level of preprocedural state- trait anxiety are more likely to perceive
higher levels of pain and discomfort during colposcopy. Simple passive visual distraction
during colposcopic examination was associated with a reduction in pain scores, however
anxiety levels were unchanged. A Cochrane review in 2007 concluded that anxiety appears to be
reduced by playing music during colposcopy. Although information leaflets did not reduce
anxiety levels, they did increase knowledge levels and helped with consenting for the
procedure.
Virtual reality is a relatively new intervention, which has been studied as a
non-pharmacological method for pain relief. VR as a form of managing pain has been studied in
paediatrics, dentistry, burns treatment, treatment of chronic pain. It has not been studied
in the management of pain of gynaecological procedures, which are increasingly being
performed as office procedures.
It acts as a method of distraction for pain relief by changing the activity of the body's
pain modulation system. This multisensory technology gives an immersive and engaging
experience and serves as a distraction technique. Head tracking systems, visually stimulating
scenery and audio and tactile feedback enable integration of many sensory experiences.
Different psychological factors influence the effectiveness of the analgesic effect of VR.
While sense of presence influence the effectiveness of VR as a distraction tool, anxiety as
well as positive emotions directly affects the experience of pain.
VR distraction has been associated with significant increases in pain threshold and pain
tolerance and significant decreases in pain intensity, time spent thinking about pain, and
self-reported anxiety, relative to baseline. Repeated exposure did not appear to affect the
benefits of VR. Simultaneous exposure to VR and supplementary sound increases pain tolerance.
Pain management in ambulatory procedures should be multimodal and should include both
pharmacological and non-pharmacological interventions. Giving the patient a range of options
will increase the number of successful procedures in the outpatient setting and improve
patient experience.
RATIONALE FOR CURRENT STUDY
To study the role of distraction techniques for management of acute pain in ambulatory
gynaecology procedures and to assess feasibility of using Virtual Reality for managing pain.
ASSESSMENT AND FOLLOW-UP
The study will aim to recruit 40 patients and randomise them via computer generated random
number allocation to either the VR intervention group or those having treatment as per
routine protocol.
Both groups of patients will fill a pre and post procedural questionnaire. Pain and anxiety
scores prior to the procedure and after the procedure will be compared against a control
group of 20 patients for pain management by standard protocol. Scores will be measured by a
Numeric Rating Scale (NRS) which is a validated measure of pain which is easy to use, has
high compliance rates and is detects meaningful changes in pain. The NRS is an 11-point scale
consisting of integers from 0 through 10; 0 representing ''No pain'' and 10 representing
''worst imaginable pain.'' Respondents select the single number that best represents their
pain intensity. Ratings of pre-operative anxiety were measured by an 11-point numeric rating
scale: 'How would you rate any anxiety you may currently be feeling' 0 (no anxiety) and 10
(worst anxiety imaginable).
The VR intervention will involve watching a standard content of the video on a mobile device
using a VR headset to distract them during the procedure. The duration of the video will be
15 minutes; but the video will only be played for the duration of the outpatient
hysteroscopy. Patients are allowed to stop viewing the video if they so desire and this will
be recorded.
A semi-structured interview will be conducted with the patients who have received the VR
intervention, each lasting approximately 20 minutes. The semi structured interviews will
allow for all participants to be asked similar question within a flexible framework. The
interviews will be conducted within 30 minutes of the procedure, in a suitable location and
will be recorded on a digital voice recorder. The questions will be focused on the women's
experiences of the procedure, in specific pain perception and questions around the VR
intervention as well as any other aspect of their hospital care they felt to be relevant. If
further clarification or exploration of any particular aspect of their care was required, the
interview will readdress these topics before the end of the interview. Interviews will
continue until no new information was being obtained, indicating that the theoretical
saturation point had been reached.
Clinician and nursing staff's perception regarding feasibility of using the VR equipment was
also assessed through a questionnaire. The clinician questionnaire will also assess the ease
of the procedure and perceived pain scores for the patient.
Patient follow up will not be routinely arranged for the purpose of the study. Routine follow
up as per clinical requirements will be arranged as routine for the procedure performed.
The study will end once the proposed numbers of patients have been recruited and data
analysis completed. Participants will be debriefed after their participation in the study and
will be directed to suitable support agencies if necessary.
STATISTICS AND DATA ANALYSIS
The recruitment of women and interviewing proceeded alongside data coding and preliminary
analysis.
Interviews will be transcribed verbatim and initially coded by reading and re reading the
transcript and making notes, drawing on the observations made during the interviews and
transcription. Transcripts will be coded line-by-line, describing, summarising and attending
to linguistic elements such as pronoun and metaphor use. The transcripts will be entered into
a qualitative software package (N6) and a thematic analysis undertaken from the emergent
themes developed from these codes and cluster with related themes. Initial coding is Initial
phase will involve open coding. Axial coding and selective coding with use of constant
comparison will enable a cyclical and iterative process on the principles of grounded theory.
Analytic frame for the analysis will be linked to the primary and secondary aims.
The statistically analysis with include statistical comparison of pre and post anxiety and
pain scores as a function of membership of VR or control groups. Analysis of covariance
(ANCOVA) will be used to determine whether the VR intervention led to a significantly
difference between baseline and follow up pain and anxiety scores between VR and control arm.
Staff questionnaires will be analysed to correlate pain scores of actual vs. perceived and
feasibility of carrying out the intervention will be assessed.
Demographic data would include age, parity, menopausal status and ethnicity. Data and all
appropriate documentation will be stored for a minimum of 10 years after the completion of
the study, including the follow-up period.
REGULATORY ISSUES
ETHICS APPROVAL The Chief Investigator has obtained approval from the Newcastle and North
Tyneside 1 National Research Ethics Committee..The study must be submitted for Site Specific
Assessment (SSA) at each participating National Health Service (NHS) Trust. The Chief
Investigator will require a copy of the Trust Research &Development approval letter before
accepting participants into the study. The study will be conducted in accordance with the
recommendations for physicians involved in research on human subjects adopted by the 18th
World Medical Assembly, Helsinki 1964 and later revisions.
CONSENT Consent to enter the study will be sought from each participant only after a full
explanation has been given, an information leaflet offered and time allowed for
consideration. Signed participant consent will be obtained. The right of the participant to
refuse to participate without giving reasons will be respected. After the participant has
entered the study the clinician remains free to give alternative treatment to that specified
in the protocol at any stage if he/she feels it is in the participant's best interest, but
the reasons for doing so will be recorded. In these cases the participants remain within the
study for the purposes of follow-up and data analysis. All participants are free to withdraw
at any time from the protocol treatment without giving reasons and without prejudicing
further treatment.
In the event of the patient and the staff nurse consenting for the study but the
gynaecologist not consenting for the procedure, the patient will be recruited and randomised
as per protocol. In the event of the patient and the gynaecologist consenting for the study,
but the staff nurse not consenting for the procedure, the patient will be recruited and
randomised as per protocol. In these instances, the staff nurse and / or the gynaecologist
will not fill the questionnaire and a note will be made.
CONFIDENTIALITY
Confidentiality Information related to participants will be kept confidential and managed in
accordance with the Data Protection Act, NHS Caldecott Principles, The Research Governance
Framework for Health and Social Care, and the conditions of Research Ethics Committee
Approval.
- Record Retention and Archiving When the research trial is complete, the records are kept
for a further 10 years. The approved repository for long-term storage of local records is the
Trust Modern Records Centre
The Chief Investigator will preserve the confidentiality of participants taking part in the
study and is registered under the Data Protection Act.
INDEMNITY Imperial College London holds negligent harm and non-negligent harm insurance
policies that apply to this study.
SPONSOR Imperial College London will act as the main Sponsor for this study. Delegated
responsibilities will be assigned to the NHS trusts taking part in this study.
FUNDING The study is a part of an MSc (Master of Science) thesis and there is no funding this
study.
8.7 AUDITS The study may be subject to inspection and audit by Imperial College London under
their remit as sponsor and other regulatory bodies to ensure adherence to GCP (Good Clinical
Practice) and the NHS Research Governance Framework for Health and Social Care (2nd edition).
STUDY MANAGEMENT
The day-to-day management of the study will be co-ordinated through Nandita Deo, Consultant
Obstetrician and Gynaecologist and PI for the study.
