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A randomised controlled trial to assess the feasibility of utilising virtual reality to facilitate analgesia during external cephalic version.

ABSTRACT: External cephalic version (ECV) is associated with a moderate degree of pain. Virtual reality (VR) is a technology that has shown promise in offering procedural analgesia. We undertook a clinical pilot to assess the viability of VR to reduce pain during ECV. In an open randomised controlled trial (RCT), we randomised 50 women to either VR or standard care each (25 per group). Women receiving VR were administered VR content (Skylights) via a headset. Pre- and post-procedural measures of pain, anxiety, device experience and vital signs were measured. There were no significant differences between groups (VR/no VR) in pain scores (60.68 vs 49.76; p?=?0.2), ECV success rates (80% vs 76%; p?=?0.7) or anxiety levels. The women receiving VR had a significantly higher anticipation of pain pre-procedurally (70.0 vs 50.0; p?=?0.03). 20 (80%) of the VR women indicated that they would use VR again and 22 (88%) indicated they would recommend it to a friend having ECV. There were no significant differences between groups for side effects encountered or changes in vital signs. We have shown that using VR during ECV is feasible and appears safe. Our results inform the design of future RCTs.

SUBMITTER: Smith V

PROVIDER: S-EPMC7035335 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature

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A randomised controlled trial to assess the feasibility of utilising virtual reality to facilitate analgesia during external cephalic version.

Smith Vinayak V Warty Ritesh Rikain RR Kashyap Ravi R Neil Peter P Adriaans Carol C Nair Amrish A Krishnan Sathya S Da Silva Costa Fabricio F Vollenhoven Beverley B Wallace Euan M EM

Scientific reports 20200221 1

External cephalic version (ECV) is associated with a moderate degree of pain. Virtual reality (VR) is a technology that has shown promise in offering procedural analgesia. We undertook a clinical pilot to assess the viability of VR to reduce pain during ECV. In an open randomised controlled trial (RCT), we randomised 50 women to either VR or standard care each (25 per group). Women receiving VR were administered VR content (Skylights) via a headset. Pre- and post-procedural measures of pain, anx ...[more]

PMID: 32081989

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Project description:Introduction Fetal breech presentation at terms occurs in 3 - 6% of pregnancies. External cephalic version can reduce the number of cesarean sections and vaginal breech deliveries. Different approaches are used to carry out external cephalic version. This study looked at the different approaches used in Germany and compared the approach used with the recommendations given in German and international guidelines. Material and Methods An anonymized online survey of 234 hospitals in Germany was carried out in 2018. In addition to asking about hospital structures, questions also focused on how external version was carried out in practice (preparations, tocolysis, anesthetics, etc.), on relative and absolute contraindications and on the success rate. Results 37.2% of the hospitals approached for the survey participated in the study. Of these, 98.8% performed external version procedures. The majority of participating hospitals were university hospitals (26.4%) and maximum care hospitals (35.6%) with an average number of more than 2000 births per year (60.9%). External cephalic version is the preferred (61.7%) obstetrical procedure to deal with breech presentation, rather than vaginal breech birth or primary cesarean section. 45.8% of respondents carry out external version procedures on an outpatient basis, and 42.1% of hospitals perform the procedure as an inpatient intervention, especially from the 37th week of gestation. Prior to performing an external version procedure, 21.6% of surveyed institutions carry out a vaginal examination to evaluate possible fixation of the fetal rump. 95.5% of institutions used fenoterol for tocolytic therapy; the majority using it for continuous tocolysis (70.2%). 1 - 3 attempts at external version (8.4%) were usually carried out by a specific senior physician. In most cases, no analgesics were administered. The reported rate of emergency cesarean sections was very low. The most common indication for emergency C-section was pathological CTG (56,7%). The assessment of relative and absolute contraindications varied, depending on the surveyed hospital. 67.5% asked patients to empty their bladders before carrying out external version, while 10.8% carried out external version when the bladder was filled. The reported success rate was more than 45%. After successful version, only 14.8% of hospitals arranged for patients to wear an abdominal binder. For 32.4%, the decision to apply an abdominal binder was taken on a case-by-case basis. Conclusion The approach used in Germany to carry out external cephalic version is based on the (expired) German guideline on breech presentation. Based on the evidence obtained, a number of individual recommendations should be re-evaluated. More recent international guidelines could be useful to update the standard procedure.

Project description:PURPOSE: To determine the maternal and fetal outcomes of successful external cephalic version (ECV) as well as factors predicting vaginal birth. METHODS: The ECV data over a period of three years at Universiti Kebangsaan Malaysia Medical Centre (UKMMC) between 1 September 2008 and 30 September 2010 was reviewed. Sixty-seven patients who had successful ECV were studied and reviewed for maternal, fetal, and labour outcomes. The control group comprised patients with cephalic singletons of matching parity who delivered following the index cases. RESULTS: The mean gestational age at ECV was 263 ± 6.52 days (37.5 weeks ± 6.52 days). Spontaneous labour and transient cardiotocographic (CTG) changes were the commonest early adverse effects following ECV. The reversion rate was 7.46%. The mean gestational age at delivery of the two groups was significantly different (P = 0.000) with 277.9 ± 8.91 days and 269.9 ± 9.68 days in the study group and control groups, respectively. The study group needed significantly more inductions of labour. They required more operative deliveries, had more blood loss at delivery, a higher incidence of meconium-stained liquor, and more cord around the neck. Previous flexed breeches had a threefold increase in caesarean section rate compared to previous extended breeches (44.1% versus 15.2%, P = 0.010). On the contrary, an amniotic fluid index (AFI) of 13 or more is significantly associated with a higher rate of vaginal birth (86.8% versus 48.3%, P = 0.001). CONCLUSIONS: Patients with successful ECV were at higher risk of carrying the pregnancy beyond 40 weeks and needing induction of labour, with a higher rate of caesarean section and higher rates of obstetrics complications. Extended breech and AFI 13 or more were significantly more likely to deliver vaginally postsuccessful ECV. This additional information may be useful to caution a patient with breech that ECV does not bring them to behave exactly like a normal cephalic, so that they have more realistic expectations. However, these predictive factors needed further confirmation and hopefully, in the future, they would be able to further enhance counselling prior to ECV.

Project description:BackgroundWomen who have a breech presentation at term have to decide whether to attempt external cephalic version (ECV) and how they want to give birth if the baby remains breech, either by planned caesarean section (CS) or vaginal breech birth. The aim of this study was to explore the attitudes of women with a breech presentation and health professionals who manage breech presentation to ECV.MethodsWe carried out semi-structured interviews with pregnant women with a breech presentation (n=11) and health professionals who manage breech presentation (n=11) recruited from two hospitals in North East England. We used purposive sampling to include women who chose ECV and women who chose planned CS. We analysed data using thematic analysis, comparing between individuals and seeking out disconfirming cases.ResultsFour main themes emerged from the data collected during interviews with pregnant women with a breech presentation: ECV as a means of enabling natural birth; concerns about ECV; lay and professional accounts of ECV; and breech presentation as a means of choosing planned CS. Some women's attitudes to ECV were affected by their preferences for how to give birth. Other women chose CS because ECV was not acceptable to them. Two main themes emerged from the interview data about health professionals' attitudes towards ECV: directive counselling and attitudes towards lay beliefs about ECV and breech presentation.ConclusionsWomen had a range of attitudes to ECV informed by their preferences for how to give birth; the acceptability of ECV to them; and lay accounts of ECV, which were frequently negative. Most professionals described having a preference for ECV and reported directively counselling women to choose it. Some professionals were dismissive of lay beliefs about ECV. Some key challenges for shared decision making about breech presentation were identified: health professionals counselling women directively about ECV and the differences between evidence-based information about ECV and lay beliefs. To address these challenges a number of approaches will be required.

Project description:Regular mindfulness practice benefits people both mentally and physically, but many populations who could benefit do not practice mindfulness. Virtual Reality (VR) is a new technology that helps capture participants' attention and gives users the illusion of "being there" in the 3D computer generated environment, facilitating sense of presence. By limiting distractions from the real world, increasing sense of presence and giving people an interesting place to go to practice mindfulness, Virtual Reality may facilitate mindfulness practice. Traditional Dialectical Behavioral Therapy (DBT®) mindfulness skills training was specifically designed for clinical treatment of people who have trouble focusing attention, however severe patients often show difficulties or lack of motivation to practice mindfulness during the training. The present pilot study explored whether a sample of mindfulness experts would find useful and recommend a new VR Dialectical Behavioral Therapy (DBT®) mindfulness skills training technique and whether they would show any benefit. Forty four participants attending a mindfulness conference put on an Oculus Rift DK2 Virtual Reality helmet and floated down a calm 3D computer generated virtual river while listening to digitized DBT® mindfulness skills training instructions. On subjective questionnaires completed by the participants before and after the VR DBT® mindfulness skills training session, participants reported increases/improvements in state of mindfulness, and reductions in negative emotional states. After VR, participants reported significantly less sadness, anger, and anxiety, and reported being significantly more relaxed. Participants reported a moderate to strong illusion of going inside the 3D computer generated world (i.e., moderate to high "presence" in VR) and showed high acceptance of VR as a technique to practice mindfulness. These results show encouraging preliminary evidence of the feasibility and acceptability of using VR to practice mindfulness based on clinical expert feedback. VR is a technology with potential to increase computerized dissemination of DBT® skills training modules. Future research is warranted.

Project description:To establish a clinical-based nomogram for predicting the success rate of external cephalic version (ECV) through a prospective study. This was a single-center prospective study that collected eligible breech pregnant women. 152 participants were enrolled in the training cohort, who received ECV procedures performed by a single operator. We used the training cohort to establish regression equations and prediction models. These variables include maternal factors (age, operation gestational age, pre-pregnancy BMI (Body Mass Index), operation BMI, BMI increase, multipara), ultrasound factors (fetal weight estimation, amniotic fluid index, placental location, type of breech presentation, spinal position), and anesthesia. Univariate and multivariable analyses were used to screen the factors affecting the success of ECV. A nomogram scoring model was established based on these factors. And C-index, DCA (Decision Curve Analysis) and calibration curve, Hosmer-Lemeshow test was used to verify the prediction effect of the model. Finally, 33 participants were enrolled in the testing cohort who received ECV with an unrestricted operator. We used C-index, DCA (decision curve analysis), and Hosmer-Lemeshow to verify the application value of the prediction model. The calibration curves and ROC curves of both the training cohort and testing cohort are plotted for internal and external validation of the model. The ECV success rate of the training cohort was 62.5%. Univariate analysis showed that the predictors related to the success rate of ECV were age, BMI increase value, AFI (amniotic fluid index), breech type, placental location, spinal position, anesthesia, and multipara. The prediction thresholds of the corresponding indexes were calculated according to the Youden index. Multivariate logistic regression analysis showed that BMI increase ≥ 3.85 kg/m2, AFI ≥ 10.6 cm, anesthesia, multipara, and non-anterior placenta were independent predictors of ECV success. Through the internal and external validation, it is confirmed that the model has a good calibration and prediction ability. Our nomogram has a good ability to predict the success rate of ECV.

Dataset Information

A randomised controlled trial to assess the feasibility of utilising virtual reality to facilitate analgesia during external cephalic version.

Publications

A randomised controlled trial to assess the feasibility of utilising virtual reality to facilitate analgesia during external cephalic version.

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