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The goal of this observational study is to evaluate the communication between the anesthesiologist and the patient prior the initiation and during the administration of the labor neuraxial analgesia.
The investigators hypothesize that there will be differences among anesthesiologists during the informed consent process and communication during the procedure, specifically, how the anesthesiologists describe the technical aspects of the procedure, alternatives, risks, complications, and expected effects of labour neuraxial analgesia.
The anesthesiologists will be observed during a routine labor neuraxial analgesia procedure for healthy uncomplicated patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anesthesiologists | All anesthesiologists providing labor neuraxial analgesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Interventions. | Other | No interventions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Informed consent | Incidence of key elements (such as technique desciption, alternatives, risks, complications, and expected effects) during the consent process before the labour neuraxial analgesia procedure. This will be assessed using a structured observation checklist with dichotomous variables (yes/no). | From the first contact with the patient before labour neuraxial analgesia until the procedure is finished. |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure description | Proportion of consent discussions in which the staff anesthesiologist described specific steps involved in administering labour neuraxial analgesia. Unit of measure: Percentage of specific consent discussions including each pre-defined procedural element using the data collection sheet (Appendix 3) during the observation of the consent process. | During the standard clinical consent process provided to patients prior to the administration of labour neuraxial anesthesia. |
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Inclusion Criteria:
Exclusion Criteria:
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All obstetric anesthesiologists working in maternity unit
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vit B Gunka, MD | Contact | 604-875-6078 | vgunka@cw.bc.ca | |
| Juliana Barrera, MD | Contact | 604-875-6076 | juliana.barrera@cw.bc.ca |
| Name | Affiliation | Role |
|---|---|---|
| Vit B Gunka, MD | Department of Anesthesia at BC Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesia at BC Women's Hospital, University of British Columbia. | Recruiting | Vancouver | British Columbia | V6H 3N1 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27988961 | Result | Yentis SM, Hartle AJ, Barker IR, Barker P, Bogod DG, Clutton-Brock TH, Ruck Keene A, Leifer S, Naughton A, Plunkett E. AAGBI: Consent for anaesthesia 2017: Association of Anaesthetists of Great Britain and Ireland. Anaesthesia. 2017 Jan;72(1):93-105. doi: 10.1111/anae.13762. | |
| 24898765 | Result | Tait AR, Teig MK, Voepel-Lewis T. Informed consent for anesthesia: a review of practice and strategies for optimizing the consent process. Can J Anaesth. 2014 Sep;61(9):832-42. doi: 10.1007/s12630-014-0188-8. Epub 2014 Jun 5. |
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| Additional labour analgesia options | Proportion of specific consent discussions in which the staff anesthesiologist offered additional labour analgesia options. Unit of measure: percentage of specific consent discussions in which alternative analgesia options were offered using the data collection sheet (Appendix 3) to document whether alternatives were discussed and which options (if any) were offered. | During the standard clinical consent process provided to patients prior to the administration of labour neuraxial analgesia. |
| Risks and complications | Proportion of specific consent discussion in which specific risks and complications of labour neuraxial analgesia were mentioned and described to the patient in further detail. Unit of measure: percentage of specific consent discussions mentioning each risk; proportion thoroughly described versus briefly mentioned using the data collection sheet (Appendix 3). | During the standard clinical consent process provided to patients prior to the administration of labour neuraxial analgesia. |
| Anticipated effects | Proportion of specific consent discussions that included discussion of what the patient should expect after the labour neuraxial anesthesia procedure. Unit of measure: percentage of specific consent discussions where each anticipated effect was mentioned (pre- and/or post-procedure) using the data collection sheet (Appendix 3). | During the standard clinical consent process provided to patients prior to the administration of labour neuraxial analgesia. |
| Patient information sheets | Proportion of specific consent discussion in which the staff anesthesiologist being observed mentioned or offered the use of patient information sheets on labour neuraxial analgesia. Unit of measure: percentage of specific consent discussion involving the use or mention of an information sheet, which will be noted on the data collection sheet (Appendix 3) throughout the observed consent process. | During the standard clinical consent process provided to patients prior to the administration of labour neuraxial analgesia. |
| 9305553 | Result | Pattee C, Ballantyne M, Milne B. Epidural analgesia for labour and delivery: informed consent issues. Can J Anaesth. 1997 Sep;44(9):918-23. doi: 10.1007/BF03011961. |
| 29781504 | Result | Anim-Somuah M, Smyth RM, Cyna AM, Cuthbert A. Epidural versus non-epidural or no analgesia for pain management in labour. Cochrane Database Syst Rev. 2018 May 21;5(5):CD000331. doi: 10.1002/14651858.CD000331.pub4. |