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| ID | Type | Description | Link |
|---|---|---|---|
| STRYKER | Other Grant/Funding Number | AHNS Endocrine Surgery Section Stryker Research Award |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention: TISCAV | Experimental |
| |
| Control: Standard Consent | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient knowledge score using a 10-item internally validated Thyroid Surgery Knowledge Assessment | 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. | Immediately after study enrollment (pre-consent) and immediately following the surgical consent process (post-consent) |
| Decisional Conflict Score using the Decisional Conflict Scale (DCS) | 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. | Preoperatively (after the consent process and before surgery) |
| Satisfaction with Decision Score using the Satisfaction with Decision Scale (SDS) | 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. | Immediately after consent (Preoperative), Postoperative Day 22, and Postoperative Day 100 |
| Decision Regret Score using the Decision Regret Scale (DRS) | 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. |
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Inclusion Criteria Fluent in English
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Annie Moroco Assistant Professor, MD | Contact | 215-955-6826 | Annie.Moroco@jefferson.edu | |
| Hani Research Fellow, BS | Contact | 3216091134 | hxs597@jefferson.edu |
| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Cottrill Assistant Professor and Program Director, MD | Assistant Professor and Program Director | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Jefferson University | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 2612430 | Background | Levy N, Landmann L, Stermer E, Erdreich M, Beny A, Meisels R. Does a detailed explanation prior to gastroscopy reduce the patient's anxiety? Endoscopy. 1989 Nov;21(6):263-5. doi: 10.1055/s-2007-1012965. | |
| 10702461 | Background | Kindler CH, Harms C, Amsler F, Ihde-Scholl T, Scheidegger D. The visual analog scale allows effective measurement of preoperative anxiety and detection of patients' anesthetic concerns. Anesth Analg. 2000 Mar;90(3):706-12. doi: 10.1097/00000539-200003000-00036. |
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The datasets generated and analyzed during this study will not be publicly available due to patient confidentiality and institutional data-sharing policies. However, de-identified participant-level data (IPD) may be shared with qualified researchers upon reasonable request to the corresponding author, subject to institutional and ethical approvals. The data will be made available for research purposes related to patient comprehension, decision-making, and informed consent in surgical settings. Access will be granted following approval of a research proposal and a signed data access agreement.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 28, 2020 |
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| 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. |
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| Postoperative Day 22 and Postoperative Day 100 |
| Anxiety Score using the Visual Analog Scale for Anxiety (VAS-A) | 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. | Immediately after consent (Preoperative), Postoperative Day 22, and Postoperative Day 100 |
| 9583753 | Background | Thomas T, Robinson C, Champion D, McKell M, Pell M. Prediction and assessment of the severity of post-operative pain and of satisfaction with management. Pain. 1998 Apr;75(2-3):177-85. doi: 10.1016/s0304-3959(97)00218-2. |
| 2321720 | Background | McCleane GJ, Cooper R. The nature of pre-operative anxiety. Anaesthesia. 1990 Feb;45(2):153-5. doi: 10.1111/j.1365-2044.1990.tb14285.x. |
| 2589657 | Background | Domar AD, Everett LL, Keller MG. Preoperative anxiety: is it a predictable entity? Anesth Analg. 1989 Dec;69(6):763-7. |
| 23870712 | Background | D'Souza V, Blouin E, Zeitouni A, Muller K, Allison PJ. Do multimedia based information services increase knowledge and satisfaction in head and neck cancer patients? Oral Oncol. 2013 Sep;49(9):943-949. doi: 10.1016/j.oraloncology.2013.06.005. Epub 2013 Jul 16. |
| 33634455 | Background | Hakimi AA, Standiford L, Chang E, Wong BJ. Development and Assessment of a Video-Based Intervention to Improve Rhinoplasty Informed Consent. Facial Plast Surg. 2021 Oct;37(5):585-589. doi: 10.1055/s-0041-1722912. Epub 2021 Feb 25. |
| 26615812 | Background | Siu JM, Rotenberg BW, Franklin JH, Sowerby LJ. Multimedia in the informed consent process for endoscopic sinus surgery: A randomized control trial. Laryngoscope. 2016 Jun;126(6):1273-8. doi: 10.1002/lary.25793. Epub 2015 Nov 30. |
| 22589017 | Background | Nehme J, El-Khani U, Chow A, Hakky S, Ahmed AR, Purkayastha S. The use of multimedia consent programs for surgical procedures: a systematic review. Surg Innov. 2013 Feb;20(1):13-23. doi: 10.1177/1553350612446352. Epub 2012 May 14. |
| 16881949 | Background | Sudore RL, Landefeld CS, Williams BA, Barnes DE, Lindquist K, Schillinger D. Use of a modified informed consent process among vulnerable patients: a descriptive study. J Gen Intern Med. 2006 Aug;21(8):867-73. doi: 10.1111/j.1525-1497.2006.00535.x. |
| 15807957 | Background | Burns P, Keogh I, Timon C. Informed consent: a patients' perspective. J Laryngol Otol. 2005 Jan;119(1):19-22. doi: 10.1258/0022215053222860. |
| 9176798 | Background | Hekkenberg RJ, Irish JC, Rotstein LE, Brown DH, Gullane PJ. Informed consent in head and neck surgery: how much do patients actually remember? J Otolaryngol. 1997 Jun;26(3):155-9. |
| 22051081 | Background | Oosthuizen JC, Burns P, Timon C. The changing face of informed surgical consent. J Laryngol Otol. 2012 Mar;126(3):236-9. doi: 10.1017/S0022215111003021. Epub 2011 Nov 4. |
| 12724430 | Background | Kessels RP. Patients' memory for medical information. J R Soc Med. 2003 May;96(5):219-22. doi: 10.1177/014107680309600504. No abstract available. |
| 24812707 | Background | Sherlock A, Brownie S. Patients' recollection and understanding of informed consent: a literature review. ANZ J Surg. 2014 Apr;84(4):207-10. doi: 10.1111/ans.12555. |
| 21641573 | Background | Mulsow JJ, Feeley TM, Tierney S. Beyond consent--improving understanding in surgical patients. Am J Surg. 2012 Jan;203(1):112-20. doi: 10.1016/j.amjsurg.2010.12.010. Epub 2011 Jun 8. |
| Apr 9, 2025 |
| Prot_SAP_001.pdf |
| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004700 | Endocrine System Diseases |
| D013959 | Thyroid Diseases |
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