Clinical Research Directory

Effect of a Nature-View Curtain on Pain, Anxiety, and Fear During Thyroid Biopsy

Thyroid fine-needle aspiration biopsy (FNAB) may cause procedure-related pain, anxiety, and fear. This randomized controlled trial evaluated whether visual distraction with a nature-view curtain could reduce these outcomes. A total of 100 adults undergoing ultrasound-guided thyroid FNAB were randomly assigned in a 1:1 ratio to a nature-view curtain group or a standard-care control group. Participants in the intervention group were instructed to focus on a ceiling-mounted nature-view curtain throughout the biopsy, whereas participants in the control group underwent routine biopsy without this visual distraction. Pain intensity was the primary outcome; anxiety and fear of pain were secondary outcomes. Outcomes were assessed approximately 15 minutes before and approximately 15 minutes after the procedure.

The Effect of Virtual Reality Applications

Thyroid nodules are a common health problem in the adult population. Ultrasound-guided fine-needle aspiration biopsy (FNAB) is the standard diagnostic procedure for evaluating suspected thyroid nodules. Although FNAB is generally considered a safe and minimally invasive procedure, it may cause pain, anxiety, and fear. In addition, patients are instructed not to speak or cough during the procedure, and the biopsy may need to be repeated if an insufficient specimen is obtained, which can further increase psychological distress. Therefore, effective non-pharmacological interventions may help improve patient comfort during the procedure. Distraction is a widely used non-pharmacological pain management strategy that reduces patients' perception of pain and distress by redirecting their attention away from the procedure. Virtual reality (VR) is an immersive distraction technique that has shown promise in reducing procedure-related discomfort in various clinical settings. This open-label randomized controlled trial aimed to evaluate the effect of virtual reality on pain as the primary outcome and anxiety and fear of pain as secondary outcomes in patients undergoing ultrasound-guided fine-needle aspiration biopsy of suspected thyroid nodules.

Mortality Benefit of Ultrasound for Thyroid Nodules Identified With PET Imaging: Non-Inferiority Emulated Target Trial

The investigators hypothesize that all-cause mortality in patients with an incidental thyroid nodule on PET-CT who did not have thyroid ultrasound (the exposure) within 3 months of the PET-CT is non-inferior within a 5% margin to those who have thyroid ultrasound at 7-years. That is, among patients with an incidental thyroid nodule on PET-CT, mortality is no more than 5% larger (in absolute difference) for those who do not have thyroid ultrasound compared to those who do. The investigators will also report mortality differences at landmark timeframes of 1-year, 3-years, 5-years, and 10-years. To estimate group differences in mortality, the investigators will conduct a non-inferiority emulated target trial utilizing clone-censor weighting to address potential immortal time bias introduced by the 3-month grace period. The investigators will adjust for demographic, potential confounder, and mortality risk adjustor factors. The investigators will stratify analyses based on baseline disease severity (estimated 5-year relative survival risk) and disease status (progression, lymph node involvement, other sites of metastases). All subjects will be accrued from the Mass General Brigham healthcare system, which includes two academic medical centers, a specialty head and neck hospital, and multiple community hospitals and numerous community clinics.

Safety & Feasibility of Ultrasound-assisted Non-invasive Measurement of Compressibility of the Thyroid Gland in Patients Scheduled for Surgical Removal

The thyroid gland plays an important role in hormone regulation however, it is often prone to nodules. This is common with nodules being found in up to 68% of people in a neck ultrasound, with likelihood increasing with age. However, only about 1 in 20 nodules turns out to be cancerous. Diagnosis of thyroid nodules starts with ultrasonic assessment, where specific features have been identified to estimate the risk of malignancy. If further examination is recommended, Fine Needle Aspiration (FNA) is performed. A needle is inserted into the nodule and the obtained subset of cells are then classified into 6 categories (Bethesda score) after examination under the microscope. While some Bethesda scores provide very accurate malignancy predictions, others like category 4, are unspecific, with risk of malignancy ranging from 25 to 40%. For these patients, about 75% are operated on even though they are not prospectively diagnosed. Soft tissue has certain physical properties, including its compressibility, which could be quantified by measuring the pressure required to deform it. It has been found that cancerous tissue is often harder than the surrounding healthy tissue. Compremium, a Swiss company which has its headquarters in Muri bei Bern, has developed a device that can be used to measure the compressibility of tissue, similarly to palpation but providing a quantitative assessment. The present study aims to investigate the feasibility and preliminary efficacy of this new technology to predict if thyroid nodules of patients scheduled for surgical removal based on FNA analysis are malignant or not.

Thyroid Nodule Gene Sequencing in a Danish Population

This pilot study aims at describing the prevalence and distribution of molecular alterations in thyroid nodules of benign and malignant origin at the level of DNA and RNA in a Danish population. Patients with thyroid nodules suspected of malignancy is included prospectively. Tissue samples are collected for molecular analyses form surgical specimens and bloodsamples, and preoperative clincial features are registered.