None listed
Conditions
Brief summary
Introduction: External cephalic version (ECV) is a procedure whereby a fetus is manually rotated, by applying pressure to the maternal abdomen, from a bottom/feet first position to the preferred head first position to enable safer vaginal delivery. Whilst safe and low-risk, it has been associated with moderate pain, in part, due to the lack of administered analgesia. To address this, research groups around the world have experimented with various modalities of relief, including regional anaesthesia, hypnosis, and systemic opioids; but have not produced any conclusive demonstration of benefit to date. As such, there is a clinical gap in addressing pain during the procedure. Virtual reality (VR) is a technological medium that is used to create simulated scenarios in which users are immersed and able to interact with through stimulation of the senses. In recent years, there has been a growing interest in medicine for its potential to provide pain relief. To date, positive results have been observed in patients requiring port access, venepuncture, chronic wound/burn dressing changes, and episiotomy. The mechanism responsible for this phenomenon is not yet fully understood, but is attributed to its ability to distract users from perceiving pain and also due to neurophysiological changes that result from long-term use. Given the potential of VR to facilitate analgesia and the lack of effective pain relief during ECV, this study will function as a proof-of-concept to determine if VR technology can be used to reduce pain perception during this procedure. Aims: 1) Investigate the effect of VR on: * Pain scores during ECV. * Physiological parameters during and after ECV. 2) Elicit patient opinion about using VR during the ECV procedure (ie. what do patients think?) and investigate potential side effects and their acceptability. Participants: In this study, 50 pregnant women will be recruited from the Breech Clinic at Monash Medical Centre. To be considered as an eligible participant, the women must fulfill the criteria outlined previously. Methods: Participants will be screened for inclusion into the study. They will then be randomly allocated to either, the control (no VR) group or the intervention (VR) group. Immediately prior to the procedure, routine monitoring and tocolysis will be performed. The ECV will commence after and patients will receive either, routine care or routine care with VR intervention. Post-procedure, vital signs will be evaluated. Questionnaires about pain perceived and device experience will also be provided. Expected Outcomes: A demonstrated potential for VR as an analgesic will be demonstrated by: * Reduced pain scores in the intervention (VR) group. * Minimal side effects. * Positive feedback about the device and content.
Interventions
At present, standard protocols for the external cephalic version procedure do not involve the administration of analgesia. These protocols also recommend performance of this procedure after 37 weeks into the pregnancy.
For this study, commercially available virtual reality headsets (Samsung Gear VR) containing custom-designed content will be provided to individuals of the intervention group for the duration of the external cephalic version procedure (which is approximately 30 minutes) and as a
At present, standard protocols for the external cephalic version procedure do not involve the administration of analgesia. These protocols also recommend performance of this procedure after 37 weeks into the pregnancy. For this study, commercially available virtual reality headsets (Samsung Gear VR) containing custom-designed content will be provided to individuals of the intervention group for the duration of the external cephalic version procedure (which is approximately 30 minutes) and as an adjunct to the standard care. To ensure adherence to the virtual reality headset, the trials will be performed under direct observation by a member of the research team and participants will be required to complete a post-procedure questionnaire. The content that will be displayed on the virtual reality headset is called "Sky Lights". In Sky Lights, the user will find herself lying down in a quiet field, staring at a starry night sky with several unlit Chinese lanterns floating gently above her. By focusing her gaze on a lantern, she will be able to set it alight, making the spectacle more colourful as the lantern floats upwards and away. Occasionally, as a reward for her continued participation; a lit lantern will either set off a series of fireworks or form Lantern Festival shapes such as a dragon or a giant fish. This content is designed to last approximately 10 minutes.
Sponsors
Monash University Department of Obstetrics and Gynaecology
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Patient must have a singleton pregnancy. * Patient must have a breech pregnancy that has been confirmed by ultrasound prior to the procedure. * Patient must have consented to an external cephalic version.
Exclusion criteria
* Women below 18 years of age. * Patients with a prior history of sensitivity to virtual reality technology, motion sickness, vertigo, seizures, epilepsy, active nausea, and vomiting. * History of prior uterine surgery, uterine abnormalities, multiple pregnancy, contraindications to vaginal delivery, maternal cardiovascular disease, severe hypertension, ASA greater than 2 (suffer a “severe medical disease”, at minimum), pre-labour rupture of membranes, placental abruption, fetal anomaly, and intra-uterine fetal death. * Patients with an intellectual or mental impairment. * People in existing dependent or unequal relationships with any member of the research team, the researcher(s) and/or the person undertaking the recruitment/consent process. * People highly dependent on medical care.
Outcome results
None listed