Evaluating the usability of a new U-shaped measuring tool for episiotomy: a mixed methods study

Once the decision to proceed to episiotomy is made, standard practice is for the attending clinician (doctor or midwife) to perform an episiotomy with no formal measuring tool. The proposed intervention is use of the 'Episiometer' prototype, which is a U-shaped, thin, transparent template made of vellum paper which is intended to be placed on the perineum and guide the correct angle and length of a mediolateral episiotomy. The template will have measurements on it, marking the angle of 0-60 degrees from the mid-line (the midline being that between the posterior fourchette of the vagina and the anus), and indicating the appropriate angle range between 45 and 60 degrees with a 'green' segment, and the length measurement of 4cm + on the 60 degree line. When applied to the perineum, the episiotomy can be performed and the clinician can cut through the Episiometer as they cut through the perineum given the very thin nature of the paper. The Episiometer would only be used if the clinical decision is made to proceed to episiotomy for delivery of the baby. It does not affect the decision to proceed to episiotomy, which is a clinical decision. The aim of the study is to: - Assess feedback from clinicians (doctors and midwives) about perceived ease of use, whether use of the device was burdensome (practicality/time) and opinions on feasibility of the tool. - Evaluate clinicians' opinions about advantages/disadvantages of the device - Evaluate the indications for episiotomy in Townsville Hospital - Assess patients' attitudes surrounding episiotomy and use of Episiometer Given the primary aim for this study is to gather feedback from clinicians, there will be multiple information sessions held to inform them about the Episiometer and how it is used. The attendance at these information sessions will be voluntary, and they will be undertaken in morning, afternoon and evening sessions such that all staff should be available to come to at least one session. Four information sessions will be run within two weeks after receiving approval, in order to educate the clinicians about the trial and the opportunity to be involved should they wish to be. There will then be one information session every week - alternating between targeting doctors and midwives given their different meeting times. During this information session, there will be an informative slideshow, handouts (flow-charts illustrating how the study will run) as well as an opportunity to practice using the Episiometer on mannequins. The information sessions will run for approximately 30 minutes and clinicians will be able to stay afterwards to practice using the Episiometer if they wish. Dr. Harsha Ananthram and Brittany Van Der Lugt will be running these information sessions. Dr. Harsha Ananthram is a consultant obstetrician and gynaecologist at the Townsville Hospital, he has trained for several years in Townsville and is well known by all of the doctors and midwives. Brittany Van Der Lugt is the fifth year medical student (at James Cook University) who will assist in running these sessions, such as informing the clinicians on which forms should be filled in, discussing where to put the forms (i.e consent forms) when completing them. She is an honours research student who has played a significant part in designing the study. There will also be an instruction sheet on how to use the Episiometer that will be available for clinicians to read at any point in time, should they not be able to attend the information sessions but still want to be involved in the study/trial the Episiometer. In the recruitment of patients on whom the Episiometer will be used, we have a thorough information sheet about the Episiometer and the study, as well as contact details available should they have any questions. Due to many of the clinicians also being educated about the trial and the Episiometer, they will also be able to provide answers to any initial questions that the patients will have. The clinicians who will use the Episiometer will include midwives who have performed episiotomies in the past, as well as resident doctors practicing in obstetrics, obstetrics registrars and consultants in obstetrics and gynaecology. Performing an episiotomy at the Townsville Hospital is a procedure that is usually undertaken by the most skilled person available, and if not, a junior member of staff (such as a junior midwife or junior doctor) is normally closely supervised by a senior member of staff. This is a principle that would continue throughout the trial, and if a junior member of staff does not feel comfortable performing a standard episiotomy, they will not be asked to perform an episiotomy using the Episiometer. However, doctors that will be performing the 6-8 week follow-up in the gynaecology clinic will not need to be proficient in performing episiotomies, and it is only required that they understand how to perform an appropriate intimate genital examination to inspect for any complications of the episiotomy that was performed. The mode of delivery will be the application of the Episiometer to the perineum in each individual woman. This will occur individually, not in groups. Each clinician that uses the Episiometer, as well as the assisting doctor or midwife, will be asked to fill out a Clinician survey to provide feedback on the device. - The Episiometer will be used on 50-100 women, depending on the number of clinicians who use the Episiometer - as we require at least 30 who have positive opinions on the device and at least 30 who have negative opinions on the device such that the results are statistically significant. The Episiometer trial will likely be running over 18 months, with the aim to compete data collection by September 2018. The Episiometer will be used at The Townsville Hospital (a regional hospital in North Queensland) in the Birth Suite. The Episiometer will only be used for women who already require an episiotomy. The intervention will not be personalised or titrated for each patient - the same Episiometer design will be used for every patient. Intervention adherence or fidelity will not be assessed.