|DREAMY is a multi-centre, observational study to investigate the incidence of accidental awareness under general anaesthesia (AAGA) using a direct questioning methodology in women having childbirth-related surgery. A recent national audit conducted by the Royal College of Anaesthetists (NAP5 ) highlighted obstetric patients as being a
disproportionately high risk for AAGA. Unfortunately, the true incidence of AAGA and its downstream psychological consequences remain unclear for obstetric patients. Approximately 2% of women need to receive a general anaesthetic (GA) in order to safely deliver their babies by caesarean section or for other surgical procedures related to
childbirth. In this study we will screen women post-operatively for recall of events during the GA using a set of standardised questions, known as the Brice questionnaire . Women will be asked questions within 24 hours of surgery and again on the following day whilst still in hospital. They will be contacted by telephone on day 30 following the index GA to complete the questionnaire again. Any women reporting awareness will be fed into a pathway of supportive care and receive screening for evidence of psychological harm at 1, 3, 6, 9 and 12 months after surgery.
Individual cases will be reviewed by an expert panel to categorise the AAGA event and identify where lessons can be learnt to improve future care for obstetric surgical patients.
1. 5th National Audit Project. RCoA and AAGBI. 2014. http://nap5.org.uk/NAP5report 2. Brice DD, Hetherington RR, Utting JE. A simple study of awareness and dreaming during anaesthesia. British
Journal of Anaesthesia 1970; 42: 535-42.
The primary ethical issue in any obstetric study is to ensure the welfare of the mother and the baby take priority over any research aims. The psychosocial and physical vulnerability of mothers should always be considered. This study does not involve any physical intervention that could cause harm or distress. In principle the DREAMY study is
concerned with monitoring satisfactory performance of general anaesthesia and detecting a risk of general anaesthesia in obstetric patients. It is already standard practice to routinely follow up any woman who receives anesthesia in childbirth (either epidural or general anaesthesia) . The primary measurement tool (i.e. the Brice
questionnaire , which has been amended for current use ) is short and has been designed with the intention to not present any significant risk or burden to the patient. It has a record of extensive use in previous research into
accidental awareness under general anaesthesia (AAGA) , allowing comparison to be made with other patient groups. Timing of routine clinical follow up of post-surgical obstetric patients means that potential participants can be screened and introduced to the study whilst inpatients by local investigators without requiring multiple additional
encounters. Participation is voluntary, explicit consent will be taken and the patient is under no obligation to enroll and complete the questionnaires if they do not wish to.
The primary ethical issues relate to timing of the study around childbirth and that by encouraging a patient to recall if they dreamed or not during the operation then adverse memories may be triggered at this sensitive time. However, since this questionnaire has been used previously with no report of ill effects, we are confident that the risk of stress induced by the questions is low. Furthermore, as an investigation into GA satisfaction it is worth considering that: (a) satisfaction questionnaires are routine; (b) Brice questioning is routine and in indeed recommended practice; (c)
satisfaction with GA is primarily concerned with the absence of recall. In fact, it could be considered advantageous to investigate the presence of awareness early, whilst a patient is still under the care of the hospital team, rather than to allow symptoms of illness, discomfort or adverse memories to go unexplored and unexplained or to emerge at a later
The DREAMY study is expected to identify cases of AAGA that might otherwise have been missed; some of these cases may be identified at the 30 day follow telephone questionnaire. With patient consent, the local care team will be notified by the research investigators that one of their patients has subsequently reported AAGA. Through sharing of
this information and promotion of structured follow up pathways, participants who experience AAGA will benefit from support services provided by local clinical care teams.
Women who receive general anaesthesia for caesarean section are more likely to have received this in the context of an emergency situation (severe maternal or fetal compromise necessitating delivery). Recruiting women and seeking consent will require tactful and sympathetic handling. Prior to approaching a woman the local investigator will seek
multidisciplinary input from the midwifery and obstetric teams to judge a woman’s suitability to participate. All investigators will be sensitive to the views of multidisciplinary team who will be informed of the project if a woman agrees to participate.
The only intrusion for participating women is phone calls, however these are not medical interventions. For this study the Brice questionnaire will be administered on three occasions within 30 days of the index general anaesthetic.
Single early Brice questionnaire application is insufficient to reliably detect AAGA, hence the “thrice Brice” methodology
with timing arranged to capture early recall of experiences in hospital and at 30 days post-operatively (in keeping with
other comparable studies using the Brice questionnaire ). Although most women will be at home with babies at the
30 day follow up point, neonatal outcomes and social situations may not always be so straightforward. The ethical
justification and practicalities of gathering and sharing information related to maternal or infant health have been
careful considered. All data governance for the study is in strict accordance with Caldicott principles, particularly
around sharing of identifiable personal information with non-direct care team investigators. Telephone follow up
procedures are structured so as to be minimally burdensome, sensitively worded and cost neutral to participants.
Feedback of clinical relevant information (but not of relevance to the direct research questions) that might arise during
30 day follow up telephone conversation and the responsibility for acting upon this will be passed onto the local care
teams accordingly. Since post-natal women will already be under routine midwifery and/or GP follow up during this
time period, very few issues are expected to occur.
From a management perspective the primary issue is achieving consistent and professional delivery of Brice
questionnaires and associated data collection at the appropriate time after surgery throughout the planned 12 month
study duration. Fortunately, the combination of support from the Obstetric Anaesthetists Association (OAA)  and Pan
London Perioperative Research Network (PLAN)  means that an established system is in place to conduct and
support high quality management of the study at a local and regional level. The decision to conduct 30 day telephone
follow up by a non-local investigator team is to ensure consistent and reliable follow up consultations and to allow
local teams to focus on clinical care responsibilities. Although this does necessitate sharing of personal information
outside the direct care team, we feel that our proposed usage meets the required ethical framework.
Ethically it would be preferable to have no exclusion criteria for participation in the study, to allow the experience of all
women receiving general anaesthesia during childbirth to be investigated. However, for pragmatic and operational
reasons the application and use of translators to allow non-English language speaking participant involvement is not
Explicit written consent will be taking for participation in the study; with a clear explanation that this will involve sharing
of personal information with research investigators that are outside the direct care team. The vast majority of potential
participants are anticipated to be young adults with intact capacity. Variance in capacity is not expected to be a
particular problem in this study, but will be assessed on a per case basis. All local investigators will be GCP training and working as medical doctors, with inherent experience and responsibilities for patient assessment and information governance.
There is also a significant logistical challenge in investigating a rare event (AAGA) in a population of patients that is also uncommon (women needing a general anaesthetic for childbirth-related surgery; approximately 2% of all childbirths). For this reasons the DREAMY study is designed as multi-centre observational research requiring data
collection of many months. Justification has been provided for expected recruitment to the study and that the numbers anticipated will provide meaningful results. It is however possible that expansion of the recruitment duration or numbers of centres may be required, if actual recruitment does not meet expected levels. Despite these challenges
we believe that the DREAMY study represents a pragmatic and achievable proposition, with potential to generate important patient-facing results relevant to improving standards of obstetric anaesthesia care.