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

Trial Summary

What is the purpose of this trial?

This study looks at how a short educational video can help people better understand thyroid surgery. Patients who have thyroid nodules and need surgery will be part of the study. Some patients will get the usual information from their doctor, while others will also watch a video that explains the surgery in a simple and clear way. The study will check if the video helps patients feel more confident about their decision, lowers anxiety, and helps them remember important information about their surgery. Patients will answer surveys before surgery, after surgery, and 3 months later.

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 data supports the effectiveness of the treatment Thyroid Informed Surgical Consent Augmenting Video (TISCAV)?

Research shows that using videos in the informed consent process can improve patient satisfaction, understanding, and reduce anxiety. For example, in Mohs surgery and cataract surgery, patients preferred video-assisted consent, which also made the process more efficient and maintained or improved comprehension. ^{1 2 3 4 5}

Is the educational video for thyroid surgery safe for humans?

The use of educational videos in the informed consent process for various surgeries, such as cataract, rhinoplasty, and Mohs surgery, has been shown to improve patient satisfaction and understanding without any reported safety concerns. ^{1 2 3 6 7}

How is the treatment TISCAV for thyroid surgery different from other treatments?

TISCAV is unique because it uses an educational video to enhance informed consent for thyroid surgery, focusing on improving patient understanding and engagement, unlike traditional methods that may rely solely on verbal or written information. ^{8 9 10 11 12}

Research Team

Elizabeth Cottrill Assistant Professor and Program Director, MD

Principal Investigator

Assistant Professor and Program Director

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

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

Multimedia in the informed consent process for endoscopic sinus surgery: A randomized control trial. [2017]

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

The use of high definition video modules for delivery of informed consent and wound care education in the Mohs Surgery Unit. [2022]

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

Video-Assisted Informed Consent for Cataract Surgery: A Randomized Controlled Trial. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Development and pilot testing of an informed consent video for patients with limb trauma prior to debridement surgery using a modified Delphi technique. [2019]

5. United States 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. [2019]

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

Visual teaching aids improve patient understanding and reduce anxiety prior to a colectomy. [2022]

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

Development and Assessment of a Video-Based Intervention to Improve Rhinoplasty Informed Consent. [2021]

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

Assessment of the Educational Quality, Accuracy, and Transparency of WebSurg Videos on Minimally Invasive Video-Assisted Parathyroidectomy. [2021]

9. Spain pubmed.ncbi.nlm.nih.gov

[Endoscopic thyroidectomy: preliminary report]. [2019]

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

Six-Year Experience With Endoscopic Thyroidectomy: Outcomes and Safety Profile. [2019]

11. Germany pubmed.ncbi.nlm.nih.gov

Long-term cosmetic results of video-assisted thyroidectomy: a comparison with conventional surgery. [2021]

12. Italy pubmed.ncbi.nlm.nih.gov

Video-assisted thyroidectomy: lessons learned after more than one decade. [2021]