Educational Video for Thyroid Surgery

(TISCAV Trial)

Overseen By Hani Research Fellow, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Thomas Jefferson University

Disqualifiers: Prior thyroid surgery, others

Compensation: Varies

Number of Visits: 5

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how an educational video might enhance understanding of thyroid surgery. It targets patients with thyroid nodules requiring surgery. Some patients will receive standard information from their doctor, while others will also watch a simple video about the surgery, known as the Thyroid Informed Surgical Consent Augmenting Video (TISCAV). The trial aims to determine if the video boosts confidence, reduces anxiety, and improves memory of important surgery details. Patients fluent in English and eligible for certain types of thyroid surgery are well-suited for this trial. As an unphased trial, this study provides a unique opportunity to contribute to research that could improve patient education and surgical outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this educational video is safe for patients undergoing thyroid surgery?

Research has shown that educational videos, such as the Thyroid Informed Surgical Consent Augmenting Video (TISCAV), are generally safe for viewing. These videos clarify medical procedures, making them easier to understand. No known safety issues or negative effects arise from watching these videos. Their purpose is to help patients feel more informed and confident about their surgery. If any concerns about watching the video arise, discussing them with a doctor is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Thyroid Informed Surgical Consent Augmenting Video (TISCAV) because it aims to enhance the understanding and decision-making process for patients undergoing thyroid surgery. Unlike standard consent procedures, which often rely solely on verbal explanations, TISCAV provides a visual and interactive experience. This method may help patients grasp complex information more easily, potentially leading to more informed consent and reduced anxiety. The hope is that by using TISCAV, patients will have a clearer understanding of the procedure and its risks, resulting in improved satisfaction and better surgical outcomes.

What evidence suggests that the Thyroid Informed Surgical Consent Augmenting Video (TISCAV) is effective for improving understanding of thyroid surgery?

Research shows that using videos during the informed consent process for surgeries can enhance patient satisfaction and understanding. Specifically, studies have found that educational videos improve comprehension of thyroid surgery details, reducing anxiety and boosting confidence. Patients who watched these videos before surgery felt more informed and retained important information more effectively. Similar positive effects have been observed in surgeries akin to thyroid operations. In this trial, participants in the intervention arm will watch the Thyroid Informed Surgical Consent Augmenting Video (TISCAV), which has been linked to improved patient experiences around surgery. ^{1 2 3 4 6}

Who Is on the Research Team?

Elizabeth Cottrill Assistant Professor and Program Director, MD

Principal Investigator

Assistant Professor and Program Director

Are You a Good Fit for This Trial?

This trial is for patients with thyroid nodules who require surgery. Participants should be those seeking to understand their upcoming procedure better. There are no specific inclusion or exclusion criteria provided, so it's assumed that all such patients are eligible unless otherwise specified by the study.

Inclusion Criteria

English is Primary Language

Fluent in English

I am a candidate for surgery to remove part or all of my thyroid.

Exclusion Criteria

I have had surgery on my thyroid.

I have agreed to undergo thyroid surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Assessment

Participants complete surveys assessing knowledge, decisional conflict, and anxiety before surgery

Immediately after study enrollment and before surgery

1 visit (in-person)

Surgical Consent Process

Participants receive standard consent information or watch an educational video to augment understanding

Immediately following study enrollment

1 visit (in-person)

Postoperative Follow-up

Participants complete surveys assessing satisfaction, decision regret, and anxiety at multiple time points after surgery

100 days

3 visits (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Thyroid Informed Surgical Consent Augmenting Video (TISCAV)

Trial Overview The trial is testing whether an educational video (TISCAV) can improve patient satisfaction and confidence compared to standard consent procedures alone. It measures the impact on understanding of thyroid surgery, decision-making confidence, anxiety levels, and information retention over time.

How Is the Trial Designed?

Group I: Intervention: TISCAV Experimental Treatment 1 Intervention

Group II: Control: Standard Consent Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Thomas Jefferson University

Lead Sponsor

Trials

475

Recruited

189,000+

Published Research Related to This Trial

In a study of 113 patients undergoing informed consent consultations for refractive excimer laser treatment, adding a video to the consultation did not change patient knowledge, satisfaction, or anxiety levels compared to traditional consultations.

However, the video-assisted consultations significantly reduced the total consultation time by nearly 5 minutes, suggesting that this method could improve efficiency without compromising patient understanding or comfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficiency of video-presented information about excimer laser treatment on ametropic patients' knowledge and satisfaction with the informed consent process. Baenninger, PB., Faes, L., Kaufmann, C., et al.[2019]

In a study of 80 cataract surgery patients, those who received video assistance during the informed consent process reported significantly higher satisfaction (86% vs. 65%) and completed the consent process in less time (5.6 minutes vs. 12.3 minutes) compared to those who only received traditional verbal advisement.

Both groups demonstrated similar levels of comprehension regarding the consent information, indicating that the video did not negatively impact understanding, but rather enhanced the overall patient experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Video-Assisted Informed Consent for Cataract Surgery: A Randomized Controlled Trial. Zhang, Y., Ruan, X., Tang, H., et al.[2022]

A pilot study with 30 participants showed that using a visual teaching aid during the informed consent process for colectomy significantly improved patients' recall of potential surgical complications and their understanding of the procedure.

The visual aid also helped reduce anxiety levels among patients, indicating that visual tools can enhance the informed consent experience, although satisfaction levels did not show a significant change.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Visual teaching aids improve patient understanding and reduce anxiety prior to a colectomy. Stewart, JA., Wood, L., Wiener, J., et al.[2022]

Citations

1. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/594859

Assessing Patient Satisfaction and Confidence After Use of ... This study looks at how a short educational video can help people better understand thyroid surgery. Patients who have thyroid nodules and ...

2. withpower.com withpower.com/trial/phase-thyroid-diseases-10-2023-a13e9

Educational Video for Thyroid Surgery (TISCAV Trial) Research shows that using videos in the informed consent process can improve patient satisfaction, understanding, and reduce anxiety. For example, in Mohs ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06918223/assessing-patient-satisfaction-and-confidence-after-use-of-educational-video-to-augment-surgical-consent-for-thyroid-surgery

Assessing Patient Satisfaction and Confidence After Use of ... This study looks at how a short educational video can help people better understand thyroid surgery.

4. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/23/NCT06918223/Prot_SAP_001.pdf

THOMAS JEFFERSON UNIVERSITY Sidney Kimmel Cancer ... Surgical Consent for Thyroid Surgery. Principal ... • Efficacy data of multimedia ... Thyroid Informed Surgical Consent Augmenting Video (TISCAV).

5. jes-online.org jes-online.org/DOIx.php?id=10.16956/jes.2025.25.2.78

Video Content-Assisted Informed Consent for ... This study aimed to evaluate understanding and satisfaction among thyroid cancer patients using written informed consent and video content for surgery ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9793427/

Educational Informed Consent Video Equivalent to ... The surgical informed consent process relies on a verbal discussion of procedural details, benefits, risks, and alternatives between surgeon and ...