RecruitingNCT05500118

Establishment of a Decision Aid Tool for Asymptomatic Small Leiomyoma and Analysis of Influencing Factors for Clinical Decision-making Using HIFU

Sponsor

Shenzhen Maternity & Child Healthcare Hospital

Enrollment

120 participants

Start Date

Aug 31, 2022

Study Type

OBSERVATIONAL

Conditions

Leiomyoma, Uterine High-Intensity Focused Ultrasound Ablation Patients Decision Aids

Summary

With the younger patients diagnosed with asymptomatic leiomyoma, delay in the reproductive age of women, the advancement of medical technology, and the rapid development of treatment methods, there are many choices between gynecologists, gynecologists and patients because of experience and knowledge. It is not easy to make the most favorable choice for patients. This study is mainly led by a committee composed of designers, doctors, nurses and patients, and based on clinical guidelines and evidence-based medicine. Co-operating with patients with asymptomatic small leiomyoma, we want to find the influencing factors of clinical decision-making, and to establish a patient decision aid tool. We use prospective trial to verify that the use of this tool can improve patients' decision-making efficacy and further improve patient-reported outcomes.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This study is developing a tool to help women with small, symptom-free uterine fibroids decide whether to get a non-invasive treatment called HIFU (high-intensity focused ultrasound) or simply monitor the fibroids over time. Researchers want to understand what factors influence women's treatment decisions. **You may be eligible if...** - You are a woman aged 18–55 with uterine fibroids diagnosed by ultrasound or MRI - Your fibroids are small (largest one under 5 cm) and you have no symptoms - You have no more than 10 fibroids total **You may NOT be eligible if...** - You have had prior fibroid surgery (any type) - You are pregnant or have an active reproductive tract infection - You have other gynecological conditions like endometriosis or ovarian tumors - You have a history of connective tissue disease or abdominal radiation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERPatients Decision Aids

Patient Decision Aids (PDAs) are an important way to facilitate making decision by patients, helping patients make specific and prudent choices by providing information about treatment options and corresponding outcomes, including benefits and risks, related to their health status. The purpose of PDAs is to encourage patients to participate in decision-making. It makes it easier for patients and doctors to discuss treatment options. It effectively promotes communication between patients and doctors. It can help patients combine their own needs and professional advice to make better, more individualized diagnosis and treatment options.