A Multimedia Presentation to Augment the Informed Consent Process for Anesthesia for Patients Undergoing Scheduled Caesarian Delivery
Running, not enrolling · Not applicable
Conditions studied: Pregnancy, Caesarean Section
In brief
The informed consent process is an important part of any surgical and anesthetic intervention. It is also perhaps the most intellectually demanding portion of interacting with the healthcare system for patients. Competent patients have full autonomy over which treatments they receive, and making an informed choice about the decision to undergo a treatment requires at minimum a discussion of the proposed intervention, its risks and benefits, and alternatives to the proposed intervention. The objective is to improve the anesthesia informed consent process for patients undergoing elective Caesarean delivery through the use of a pre-recorded audiovisual presentation that discusses the logistical aspects of perioperative care and the risks and benefits of anesthesia which is provided to patients prior to meeting their anesthesiologist. The hypothesis is that the use of an audiovisual presentation which explains the purpose and nature of anesthesia for Caesarean delivery provided to the patient at least 24 hours prior to their procedure will result in a 10% increase in the effectiveness of risk communication and treatment decision making as measured by the Combined Outcome Measure for Risk Communication and Treatment Decision Making Effectiveness (COMRADE) tool.
Key facts
- Study ID
- NCT06945250
- Run by
- Northwestern University
- People needed
- 70
- Starts
- 2025-06-06
- Expected to finish
- 2026-10-01
- Last updated by the study team
- 2026-05-27
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Age 18 or over on the day of the procedure
- Able to provide verbal and written informed consent for participation in the study
- Primarily English-speaking patients (the audiovisual presentation will be available only in English
You may not qualify if…
- Refusal or inability to participate or provide informed consent
- Primarily non-English speaking patients
- At the discretion of the attending anesthesiologist of record due to medical complexity
Where it is running
- Northwestern Medicine — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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