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?

This trial aims to improve patients' understanding of the anesthesia process for planned C-sections through a pre-recorded video, known as "Experimental Audio Visual." The video explains what to expect during anesthesia, covering both risks and benefits, and is shared with patients at least 24 hours before their procedure. The goal is to make patients feel more informed and confident about their choices. The trial seeks English-speaking pregnant women scheduled for elective C-sections who can provide consent. As an unphased trial, it offers participants the opportunity to enhance their understanding and confidence regarding anesthesia for C-sections.

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.

What prior data suggests that this audiovisual presentation is safe for improving informed consent in C-section patients?

Research has shown that tools like pre-recorded presentations can enhance understanding of medical information. These tools require no physical contact and are generally user-friendly. Studies have found that such methods can boost patient confidence and clarify medical procedures, such as C-sections.

Watching an educational video has no known side effects, making it a safe option for patients. This approach aims to improve communication and decision-making, without introducing new medications or devices. Based on current knowledge, this method should be a safe and helpful part of the informed consent process for C-sections. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Multimedia Presentation for C-Section because it's a fresh approach to preparing patients for surgery. Unlike traditional pre-surgery briefings that rely on verbal explanations or printed materials, this method uses an audiovisual presentation. This innovative approach allows expecting mothers to visualize and understand the procedure in a more engaging and comprehensive way, which might reduce anxiety and enhance patient satisfaction. By offering information in a digital format accessible before hospital visits, it provides flexibility and convenience, helping patients feel more informed and comfortable about their upcoming C-section.

What evidence suggests that this audiovisual presentation is effective for improving informed consent in C-sections?

Research has shown that audio and visual tools can help patients better understand and make decisions about their care. For example, listening to music before a C-section reduces anxiety and fear. Studies also suggest that music lessens pain and anxiety during labor. In this trial, participants in the intervention group will receive a recorded presentation using audio and visual materials to clarify and enhance the informed consent process. This method aims to improve patients' understanding of the risks and benefits of anesthesia by at least 10%. ^{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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6215648/

Effects of music intervention during caesarean delivery on ... Music during caesarean is an easy implementable and effective way of reducing stress and anxiety of the expectant mother.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04111575

Music Therapy for Women, Delivered Via Cesarean Section In the analysis of the data, one-way ANOVA, paired t-test, Kruskal Wallis-H and Wilcoxon tests were used. Main outcome measures: State anxiety level and pain ...

3. link.springer.com link.springer.com/article/10.1007/s12144-024-06095-1

Effects of planned training and music listened to before a ... Listening to music before the cesarean section was effective in reducing women's short-term and general surgical fears, and the training was ...

4. mdpi.com mdpi.com/1660-4601/20/23/7120

The Effects of Music-Based Interventions for Pain and ... Music-based interventions show promising effects in mitigating pain and anxiety in women during labour. However, the long-term effects of these interventions ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10522975/

Effect of audio-visual therapy on pain and anxiety in labor The virtual reality intervention reduced labor pain intensity and anxiety among laboring women compared to standard care.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10706633/

The Effects of Music-Based Interventions for Pain and ... Music-based interventions are not physically invasive, they usually have minimal side effects, and they are increasingly being implemented ...

7. eurjmedres.biomedcentral.com eurjmedres.biomedcentral.com/articles/10.1186/s40001-025-02758-2

Investigating the effect of the digital storytelling of peers ... The digital storytelling of peers' childbirth experiences is effective in cultivating more positive perceptions in relation to the experience of childbirth.

8. cell.com cell.com/heliyon/fulltext/S2405-8440(23)01114-3

Knowledge and confidence levels improvement among ... Study participant showed increased scores regarding confidence in their caesarean section skills according to all learning subjects (p < 0.05) ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9998068/

The effect of virtual reality on anxiety, stress, and ... Virtual reality significantly reduced anxiety and stress during cesarean sections, and increased patient satisfaction. It also had some impact on hemodynamic ...

10. sciencedirect.com sciencedirect.com/science/article/pii/S2352289521001338

Altered stress responses in adults born by Caesarean section Young adults born by C-section exhibit increased psychological vulnerability to acute stress and a prolonged period of exam-related stress.