Clinical trial · Interventional
Assessing Patient Satisfaction and Confidence After Use of Educational Video to Augment Surgical Consent for Thyroid Surgery
NCT06918223CI-TRIAL-00088512TISCAVrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Thyroid Cancer | Malignant Thyroid Gland Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Standard Consent | Behavioral | — | UNRESOLVED |
| Thyroid Informed Surgical Consent Augmenting Video (TISCAV) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention: TISCAV
- interventionNames
- Behavioral: Thyroid Informed Surgical Consent Augmenting Video (TISCAV)
- type
- PLACEBO_COMPARATOR
- label
- Control: Standard Consent
- interventionNames
- Behavioral: Standard Consent
Primary outcomes (5)
- measure
- Patient knowledge score using a 10-item internally validated Thyroid Surgery Knowledge Assessment
- timeFrame
- Immediately after study enrollment (pre-consent) and immediately following the surgical consent process (post-consent)
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (16)
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- BACKGROUNDKindler 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. PMID 10702461
- BACKGROUNDThomas 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. PMID 9583753
- BACKGROUNDMcCleane 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. PMID 2321720
- BACKGROUNDDomar AD, Everett LL, Keller MG. Preoperative anxiety: is it a predictable entity? Anesth Analg. 1989 Dec;69(6):763-7. PMID 2589657
- BACKGROUNDD'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
- BACKGROUNDHakimi 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
- BACKGROUNDSiu 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.