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NCT Number: NCT06918223

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

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.

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Key information

Conditions

Thyroid Cancer Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Neoplasms Neoplasms by Site Thyroid Diseases Thyroid Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location status: Recruiting

Location contact

Elizabeth Cottrill Assistant Professor, MD

CONTACT

[email protected]

215-955-6760

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Fluent in English

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

Exclusion criteria

  • History of prior thyroid surgery
  • Previously consented for thyroid surgery

Treatment and study plan

Thyroid Informed Surgical Consent Augmenting Video (TISCAV)

Behavioral

Participants randomized to the intervention group will receive a surgeon-created Thyroid Informed Surgical Consent Augmenting Video (TISCAV). This 8-minute video includes animated visuals and a surgeon voiceover explaining thyroid anatomy, surgical options (lobectomy vs. total thyroidectomy), risks, benefits, and expectations. The TISCAV was designed and reviewed by an endocrine surgery team to improve patient comprehension, confidence, satisfaction, and reduce decision regret compared to standard verbal consent alone.

Standard consent

Behavioral

Participants receiving the Standard Consent intervention will undergo the routine informed consent process for thyroid surgery provided by their surgeon. This process includes a verbal discussion covering thyroidectomy procedure details, potential risks and complications, benefits, alternatives such as active surveillance, and an opportunity to ask questions.

Primary outcomes

  1. Patient knowledge score using a 10-item internally validated Thyroid Surgery Knowledge Assessment

    Time frame: Immediately 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.

  2. Decisional Conflict Score using the Decisional Conflict Scale (DCS)

    Time frame: 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.

  3. Satisfaction with Decision Score using the Satisfaction with Decision Scale (SDS)

    Time frame: 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.

  4. Decision Regret Score using the Decision Regret Scale (DRS)

    Time frame: 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.

  5. Anxiety Score using the Visual Analog Scale for Anxiety (VAS-A)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Annie Moroco Assistant Professor, MD

CONTACT

[email protected]

215-955-6826

Hani Research Fellow, BS

CONTACT

[email protected]

3216091134

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Registry information

Acronym: TISCAV

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 9, 2025
Registry last updated
Apr 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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