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

Обзор

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.

Вмешательства

• Поведенческое 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 standa
• Поведенческое 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.

Первичные конечные точки

• Patient knowledge score using a 10-item internally validated Thyroid Surgery Knowledge Assessment [Срок оценки: Immediately after study enrollment (pre-consent) and immediately following the surgical consent process (post-consent)]
• Decisional Conflict Score using the Decisional Conflict Scale (DCS) [Срок оценки: Preoperatively (after the consent process and before surgery)]
• Satisfaction with Decision Score using the Satisfaction with Decision Scale (SDS) [Срок оценки: Immediately after consent (Preoperative), Postoperative Day 22, and Postoperative Day 100]
• Decision Regret Score using the Decision Regret Scale (DRS) [Срок оценки: Postoperative Day 22 and Postoperative Day 100]
• Anxiety Score using the Visual Analog Scale for Anxiety (VAS-A) [Срок оценки: Immediately after consent (Preoperative), Postoperative Day 22, and Postoperative Day 100]

Критерии участия

Inclusion Criteria Fluent in English

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

США · 1 центр

• Thomas Jefferson University — Philadelphia

Публикации

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• 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. PMID 23870712
• 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. PMID 33634455
• 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. PMID 26615812

Идентификаторы

NCT: NCT06918223 · 20E.663 · STRYKER

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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