Multimedia Presentation for C-Section

Overseen By Paul C Fitzgerald, RN,BSN,MS

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Non-English speaking, Medical complexity, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with your healthcare provider or the trial coordinators.

How does the Experimental Audio Visual treatment for C-Section differ from other treatments?

The Experimental Audio Visual treatment for C-Section is unique because it uses multimedia presentations to enhance communication and understanding, potentially increasing patient comprehension and retention compared to traditional methods. This approach leverages text, images, sound, video, and animation to deliver information more effectively. ^{1 2 3 4 5}

What data supports the effectiveness of the Experimental Audio Visual treatment for C-Section?

Research shows that using video-based multimedia information can reduce anxiety before medical procedures and improve patients' understanding of risks and complications, as seen in studies involving dilatation and curettage and dental surgery. This suggests that similar audiovisual presentations could help patients better understand and feel more at ease with C-Section procedures. ^{6 7 8 9 10}

Who Is on the Research Team?

Eleanor Kenny, MD

Principal Investigator

Northwestern Univesity

Are You a Good Fit for This Trial?

This trial is for pregnant individuals scheduled for a Caesarean delivery (C-section). The study aims to include those who are about to make an informed decision regarding their anesthesia during the procedure. Specific eligibility criteria details were not provided.

Inclusion Criteria

Able to provide verbal and written informed consent for participation in the study

Exclusion Criteria

I am willing and able to give informed consent.

Primarily non-English speaking patients

At the discretion of the attending anesthesiologist of record due to medical complexity

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Informed Consent Enhancement

Participants receive a pre-recorded audiovisual presentation discussing anesthesia risks and benefits at least 24 hours prior to their procedure

1 day

1 virtual visit

Procedure and Immediate Post-Procedure

Participants undergo the scheduled Caesarean delivery and immediate post-procedure monitoring

1 day

Follow-up

Participants are monitored for satisfaction and anxiety levels related to the anesthetic informed consent process

1 day

What Are the Treatments Tested in This Trial?

Interventions

• Experimental Audio Visual

Trial Overview The trial is testing whether a pre-recorded audiovisual presentation explaining anesthesia's purpose, risks, and benefits can improve patients' understanding. It will be given at least 24 hours before meeting the anesthesiologist and its effectiveness measured by the COMRADE tool.

How Is the Trial Designed?

Group I: Intervention Group Experimental Treatment 1 Intervention

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.

Group II: Control Group Active Control 1 Intervention

Control Group: Participants randomized to the control group will not receive the link to the audiovisual presentation

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Published Research Related to This Trial

Women who received video-based multimedia information (MMI) before undergoing dilatation and curettage (D&C) experienced significantly lower anxiety levels compared to those who received conventional written information, indicating that MMI is effective in reducing preoperative anxiety.

Patients who viewed the MMI reported higher satisfaction rates (75%) compared to those who received written information (50%), and they also experienced less severe postoperative pain, suggesting that MMI enhances the overall patient experience during D&C procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of video-based multimedia information in reduction of anxiety before dilatation and curettage. Yilmaz, G., Akca, A., Ay, N., et al.[2021]

Citations

1. Turkey pubmed.ncbi.nlm.nih.gov

The role of video-based multimedia information in reduction of anxiety before dilatation and curettage. [2021]

2. Scotland pubmed.ncbi.nlm.nih.gov

Use of an educational video with mobile technology for the informed consent process: A randomised controlled trial on patients undergoing surgery for an impacted lower third molar. [2023]

3. Ireland pubmed.ncbi.nlm.nih.gov

Red, orange and green Caesarean sections: a new communication tool for on-call obstetricians. [2008]

4. Australia pubmed.ncbi.nlm.nih.gov

INFORMed choices: facilitating shared decision-making in health care. [2015]

5. United States pubmed.ncbi.nlm.nih.gov

Understanding and recollection of the risks associated with cesarean delivery during the consent process. [2016]

6. Germany pubmed.ncbi.nlm.nih.gov

[Principles and advanced techniques for better internetpresentations in obstetrics and gynecology]. [2008]

7. United States pubmed.ncbi.nlm.nih.gov

Computer-generated graphical presentations: use of multimedia to enhance communication. [2006]

8. England pubmed.ncbi.nlm.nih.gov

Application of the RealAudio package to computerized medical lectures. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

The fetal imaging workstation demonstration project. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Simple virtual reality display of fetal volume ultrasound. [2016]