Assessing Patient Satisfaction and Confidence After Use of Educational Video to Augment Surgical Consent for Thyroid Surgery
NCT ID: NCT06918223
Last Updated: 2025-04-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2023-11-10
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Intervention: TISCAV
Thyroid Informed Surgical Consent Augmenting Video (TISCAV)
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.
Control: Standard Consent
Standard Consent
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.
Interventions
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Thyroid Informed Surgical Consent Augmenting Video (TISCAV)
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
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.
Eligibility Criteria
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Inclusion Criteria
* ≥18 years old at time of consent
* Eligible for Thyroidectomy, lobectomy, isthmusectomy for any indication
Exclusion Criteria
* Previously consented for thyroid surgery
18 Years
ALL
No
Sponsors
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Thomas Jefferson University
OTHER
Responsible Party
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Principal Investigators
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Elizabeth Cottrill Assistant Professor and Program Director, MD
Role: PRINCIPAL_INVESTIGATOR
Assistant Professor and Program Director
Locations
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Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
Domar AD, Everett LL, Keller MG. Preoperative anxiety: is it a predictable entity? Anesth Analg. 1989 Dec;69(6):763-7.
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.
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.
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.
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.
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.
Burns P, Keogh I, Timon C. Informed consent: a patients' perspective. J Laryngol Otol. 2005 Jan;119(1):19-22. doi: 10.1258/0022215053222860.
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.
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.
Kessels RP. Patients' memory for medical information. J R Soc Med. 2003 May;96(5):219-22. doi: 10.1177/014107680309600504. No abstract available.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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STRYKER
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
20E.663
Identifier Type: -
Identifier Source: org_study_id
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