Hypnosis Antenatal Training for Childbirth (HATCh): a randomised controlled trial [NCT00282204]

BACKGROUND: Although medical interventions play an important role in preserving lives and maternal comfort they have become increasingly routine in normal childbirth. This may increase the risk of associated complications and a less satisfactory birth experience. Antenatal hypnosis is associated with a reduced need for pharmacological interventions during childbirth. This trial seeks to determine the efficacy or otherwise of antenatal group hypnosis preparation for childbirth in late pregnancy. METHODS/DESIGN: A single centre, randomised controlled trial using a 3 arm parallel group design in the largest tertiary maternity unit in South Australia. Group 1 participants receive antenatal hypnosis training in preparation for childbirth administered by a qualified hypnotherapist with the use of an audio compact disc on hypnosis for re-enforcement; Group 2 consists of antenatal hypnosis training in preparation for childbirth using an audio compact disc on hypnosis administered by a nurse with no training in hypnotherapy; Group 3 participants continue with their usual preparation for childbirth with no additional intervention. Women > 34 and < 39 weeks gestation, planning a vaginal birth, not in active labour, with a singleton, viable fetus of vertex presentation, are eligible to participate. Allocation concealment is achieved using telephone randomisation. Participants assigned to hypnosis groups commence hypnosis training as near as possible to 37 weeks gestation. Treatment allocations are concealed from treating obstetricians, anaesthetists, midwives and those personnel collecting and analysing data. Our sample size of 135 women/group gives the study 80% power to detect a clinically relevant fall of 20% in the number of women requiring pharmacological analgesia – the primary endpoint. We estimate that approximately 5–10% of women will deliver prior to receiving their allocated intervention. We plan to recruit 150 women/group and perform sequential interim analyses when 150 and 300 participants have been recruited. All participant data will be analysed, by a researcher blinded to treatment allocation, according to the "Intention to treat" principle with comprehensive pre-planned cost- benefit and subgroup analyses. DISCUSSION: If effective, hypnosis would be a simple, inexpensive way to improve the childbirth experience, reduce complications associated with pharmacological interventions, yield cost savings in maternity care, and this trial will provide evidence to guide clinical practice

Effects of Neuraxial Blockade May Be Difficult To Study Using Large Randomized Controlled Trials: The PeriOperative Epidural Trial (POET) Pilot Study

Early randomized controlled trials have suggested that neuraxial blockade may reduce cardiorespiratory complications after non-cardiothoracic surgery, but recent larger trials have been inconclusive. We conducted a pilot study to assess the feasibility of conducting a large multicentre randomized controlled trial in Canada.After Research Ethics Board approvals from the participating institutions, subjects were recruited if they were > or = 45 years old, had an expected hospital stay > or = 48 hours, were undergoing a noncardiothoracic procedure amenable to epidural analgesia, met one of six risk criteria, and did not have contraindications to neuraxial blockade. After informed consent, subjects were randomly allocated to combined epidural analgesia (epidural group) and neuraxial anesthesia, with or without general anesthesia, or intravenous opioid analgesia (IV group) and general anesthesia. The primary outcomes were the rate of recruitment and the percents of eligible patients recruited, crossed over, and followed completely. Feasibility targets were defined a priori. A blinded, independent committee adjudicated the secondary clinical outcomes. Subjects were followed daily while in hospital and then at 30 days after surgery. Analysis was intention-to-treat. Over a 15-month period, the recruitment rate was 0.5+/-0.3 (mean+/-SEM) subjects per week per centre; 112/494 (22.7%) eligible subjects were recruited at four tertiary-care teaching hospitals in Canada. Thirteen (26.5%) of 49 subjects in the epidural group crossed over to the IV group; seven (14.3%) were due to failed or inadequate analgesia or complications from epidural analgesia. Five (9.8%) of 51 subjects in the IV group crossed over to the epidural group but none were due to inadequate analgesia or complications. Ninety-eight (97.0%) of 101 subjects were successfully followed up until 30 days after their surgery.Of the criteria we defined for the feasibility of a full-scale trial, only the follow-up target was met. The other feasibility outcomes did not meet our preset criteria for success. The results suggest that a large multicentre trial may not be a feasible design to study the perioperative effects of neuraxial blockade.ClinicalTrials.gov NCT 0221260 Controlled-Trials.com ISRCTN 35629817

Interaction of hyperalgesia and sensory loss in complex regional pain syndrome type I (CRPS I)

Sensory abnormalities are a key feature of Complex Regional Pain Syndrome (CRPS). In order to characterise these changes in patients suffering from acute or chronic CRPS I, we used Quantitative Sensory Testing (QST) in comparison to an age and gender matched control group

The HATCh Trial: hypnosis antenatal training for childbirth.

The evidence appeared to suggest that the use of hypnosis in childbirth: decreases analgesia requirements during labour; decreases oxytocin requirements during labour and, increases the incidence of spontaneous vaginal birth. A research gap was identified that the Hypnosis Antenatal Training for Childbirth (HATCh) Trial was designed to fill. The HATCh Trial was a comprehensive, high-quality, randomised trial that included 448 pregnant women in late pregnancy. It was designed to assess the efficacy of a short, three-session, standardised hypnosis intervention in late pregnancy. The HATCh study findings show that, unlike in all but one previous study, this hypnosis intervention in the third trimester was ineffective in reducing analgesia requirements during childbirth. The increased incidence of induction required in hypnosis groups when compared with controls was unexpected and suggests that hypnosis may have an effect in the non-pharmacological inhibition of spontaneous labour. Subgroup analysis suggested that hypnosis may reduce analgesia requirements when supplemented by yoga. The addition of the HATCh Trial results has substantially increased the heterogeneity of the systematic review. Systematic review sub-group analyses, according to the timing of the hypnosis training during pregnancy, suggest that training in the third trimester is ineffective in reducing analgesia requirements during labour and childbirth. However hypnosis training commencing early in pregnancy, either in the first or second trimester, may decrease pharmacological analgesia use during childbirth. Further research is required to investigate why hypnosis might inhibit the spontaneous onset of labour and how this effect might be negated, minimised or utilised. Further research is also required to investigate the optimal timing to commence antenatal hypnosis training, the number of sessions and the types of suggestions that might be most effective. Yoga may be a useful adjunct to the hypnosis intervention and should be researched further as a sole technique and together with antenatal hypnosis training during pregnancy. There is a clear need for high quality trials where hypnosis training occurs before the 3rd trimester. Ideally, training after the 3rd trimester should be compared with antenatal hypnosis training before the 3rd trimester.Thesis (Ph.D.) -- University of Adelaide, School of Paediatrics and Reproductive Health, 201

Preanesthetic nurse communication with children and parents-an observational study.

The impact of communication within the perioperative period is an area of increasing research interest. Suggestions are phrases or actions that can lead to subconscious nonvolitional changes in patient perception, mood, and/or behavior. Statements functioning as suggestions may induce positive or negative perceptual responses and experiences. Children and anxious patients are particularly responsive to the effects of suggestion. We aimed to identify positively and negatively worded statements used during the provision of preoperative information by nursing staff in a tertiary referral center for pediatric care

Non-pharmacological interventions for induction of anaesthesia in children. (Protocol)

Published in Cochrane Database of Systematic Reviews 2008 Issue 2 at www.interscience.wiley.com Copyright © 2008 The Cochrane Collaboration.AM Cyna, P Middleton, E Hol