Educational Video for Thyroid Surgery Consent

This study is looking at whether a short educational video, called the Thyroid Informed Surgical Consent Augmenting Video (TISCAV), can help patients better understand and feel more confident about their thyroid surgery. If you join, you would either receive the usual information from your surgeon or also watch the TISCAV video, which uses animations and a surgeon's voice to explain thyroid anatomy and surgical options. The study aims to see if the video improves your knowledge, reduces decisional conflict (feeling unsure about your decision), and increases your satisfaction with your decision. We are looking for 60 participants who are at least 18 years old, speak English, and are eligible for thyroid surgery. The study is currently unclear on its recruitment status.

Study design
This is an interventional study with a planned enrollment of 60 participants. Some participants will receive standard consent, while others will also watch the TISCAV video.
What's involved
You would answer surveys immediately after study enrollment (pre-consent), immediately after the surgical consent process (post-consent), preoperatively (before surgery), on Postoperative Day 22, and on Postoperative Day 100.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 100 days after surgery to assess satisfaction with their decision.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06918223

Assessing Patient Satisfaction and Confidence After Use of Educational Video to Augment Surgical Consent for Thyroid Surgery

Recruiting
NAAges 18+InterventionalHealth services
Thomas Jefferson University
~60 participants
Updated 2025-04-13 on ClinicalTrials.gov
What's tested:Thyroid Informed Surgical Consent Augmenting Video (TISCAV)Standard Consent

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Patient knowledge score using a 10-item internally validated Thyroid Surgery Knowledge Assessment
Measured over Immediately after study enrollment (pre-consent) and immediately following the surgical consent process (post-consent)
+4 more outcomes measured
Thyroid Cancer
1 sites across 1 states
Pennsylvania1
  • Elizabeth Cottrill Assistant Professor and Program Director, MD · PRINCIPAL_INVESTIGATOR · Assistant Professor and Program Director
Annie Moroco Assistant Professor, MD
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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

English is Primary Language
≥18 years old at time of consent
Eligible for Thyroidectomy, lobectomy, isthmusectomy for any indication

Exclusion

History of prior thyroid surgery
Previously consented for thyroid surgery
  • Patient knowledge score using a 10-item internally validated Thyroid Surgery Knowledge AssessmentImmediately after study enrollment (pre-consent) and immediately following the surgical consent process (post-consent)

    This outcome measures patient knowledge of thyroid surgery, including indications, procedural options, risks, and benefits. A 10-question internally developed and validated multiple-choice questionnaire will be administered before and after the informed consent process. Each correct answer is scored as 1 point, with a total score ranging from 0 to 10. Higher scores indicate greater understanding and retention of surgical information.

  • Decisional Conflict Score using the Decisional Conflict Scale (DCS)Preoperatively (after the consent process and before surgery)

    This outcome measures patient uncertainty and confidence related to thyroid surgery decision-making using the validated 16-item Decisional Conflict Scale (DCS). The DCS evaluates five subdomains: uncertainty, feeling informed, values clarity, support, and perceived effectiveness of the decision. Each item is scored from 0 (strongly agree) to 4 (strongly disagree), then standardized to a total score ranging from 0 to 100. Higher scores reflect greater decisional conflict and more difficulty with making a decision.

  • Satisfaction with Decision Score using the Satisfaction with Decision Scale (SDS)Immediately after consent (Preoperative), Postoperative Day 22, and Postoperative Day 100

    This outcome assesses patient satisfaction with their decision to undergo thyroid surgery using the validated 6-item Satisfaction with Decision Scale (SDS). Each item is scored from 1 (not satisfied) to 5 (very satisfied), with a total score ranging from 6 to 30. Higher scores indicate greater satisfaction with the decision-making process and outcome.

  • Decision Regret Score using the Decision Regret Scale (DRS)Postoperative Day 22 and Postoperative Day 100

    This outcome evaluates postoperative regret related to undergoing thyroid surgery using the validated 5-item Decision Regret Scale (DRS). Each item is scored from 1 (strongly agree) to 5 (strongly disagree), with scores converted to a 0-100 scale. Higher scores reflect greater decision regret.

  • Anxiety Score using the Visual Analog Scale for Anxiety (VAS-A)Immediately after consent (Preoperative), Postoperative Day 22, and Postoperative Day 100

    This outcome measures patients' current level of anxiety using the validated Visual Analog Scale for Anxiety (VAS-A), a single-item scale presented as a 100 mm line ranging from "calm" to "anxious." Participants place a mark on the scale reflecting their current state. The score is recorded as a number from 0 to 100, with higher scores indicating greater anxiety.