A Multimedia Presentation to Augment the Informed Consent Process for Anesthesia for Patients Undergoing Scheduled Caesarian Delivery

May 22, 2026 updated by: Eleanor Kenny, Northwestern University

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age 18 or over on the day of the procedure
  2. Able to provide verbal and written informed consent for participation in the study
  3. Primarily English-speaking patients (the audiovisual presentation will be available only in English

Exclusion Criteria:

  1. Refusal or inability to participate or provide informed consent
  2. Primarily non-English speaking patients
  3. At the discretion of the attending anesthesiologist of record due to medical complexity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
Intervention Group: Participants randomized to the intervention group will receive a link to the audiovisual presentation via e-mail to review prior to coming into the hospital for caesarean section.
Other: Experimental Audio Visual
Participants in this group will receive the audiovisual presentation
No Intervention: Control Group
Control Group: Participants randomized to the control group will not receive the link to the audiovisual presentation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
COMRADE survey score
Time Frame: 1 Day after delivery of baby
COMRADE score for risk communication and treatment decision making on a 100-point scale, ranging from 0 (decision-making not informed at all (poor)) to 100 (most informed decision possible (good))
1 Day after delivery of baby

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demographic factors associated with increase in informed decision-making
Time Frame: 1 Day after delivery of baby
Demographic factors associated with increase in informed decision-making including age, education level, history of prior Caesarean delivery, history of other anesthetics (such as labor epidurals or general anesthetics)
1 Day after delivery of baby
Level of subjective anxiety associated with the proposed anesthetic
Time Frame: 1 Day after delivery of baby
Level of subjective anxiety associated with the proposed anesthetic based on a scale of 1-5 (1) strongly disagree, (2) disagree, (3) neither agree nor disagree, (4) agree, (5) strongly agree).
1 Day after delivery of baby
Level of subjective fear associated with the proposed anesthetic
Time Frame: 1 Day after delivery of baby
Level of subjective fear associated with the proposed anesthetic measured on a scale of 1-5 (1) strongly disagree, (2) disagree, (3) neither agree nor disagree, (4) agree, (5) strongly agree)
1 Day after delivery of baby
Level of satisfaction with the anesthetic informed consent process
Time Frame: 1 Day after delivery
Level of satisfaction with the anesthetic informed consent process based on a scale of 1-5 (1) strongly disagree, (2) disagree, (3) neither agree nor disagree, (4) agree, (5) strongly agree).
1 Day after delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Investigators

  • Principal Investigator: Eleanor Kenny, MD, Northwestern Univesity

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 6, 2025

Primary Completion (Actual)

May 22, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

April 18, 2025

First Submitted That Met QC Criteria

April 18, 2025

First Posted (Actual)

April 25, 2025

Study Record Updates

Last Update Posted (Actual)

May 27, 2026

Last Update Submitted That Met QC Criteria

May 22, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • STU00222960

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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