Clinical trial · Observational
Establishment of a Decision Aid Tool for Asymptomatic Small Leiomyoma and Analysis of Influencing Factors for Clinical Decision-making Using HIFU
- 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)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| High-Intensity Focused Ultrasound Ablation | — | UNRESOLVED | — |
| Leiomyoma, Uterine | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
| Patients Decision Aids | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Patients Decision Aids | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- communication without PADs
- description
- We use traditional communication ways to discuss the conditions with patients.
- label
- communication with PADs
- description
- The committee, composed of designers, doctors, nurses and patients, bases on guidelines and evidence-based medicine to make a tool. And we use this tool to discuss the conditions with patients.
- interventionNames
- Other: Patients Decision Aids
Primary outcomes (1)
- measure
- Patient satisfaction after using PDAs
- timeFrame
- 6-12 months
- description
- The patients in PDAs will undertake the treatment by PDAs. And we will collect the satisfaction after 12 months.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 55 Years
Show eligibility criteria text
Inclusion Criteria: 1. Diagnosis of leiomyoma: patients with leiomyoma diagnosed by imaging examinations (ultrasound and MRI) have no clinical symptoms; 2. Female with age in 18-55 years old; 3. The maximum diameter of a single leiomyoma is less than 5m, and the number does not exceed 10 by MRI; 4. No contraindications for sedation and analgesia; 5. Patients and their families agree to join this study, and can follow up on time. Exclusion Criteria: 1. History of myomectomy, including transabdominal, laparoscopic, hysteroscopy, etc.; 2. History of connective tissue diseases or radiotherapy, especially abdominal radiotherapy; 3. With pregnancy, acute inflammation of the reproductive tract, or other gynecological benign and malignant diseases such as endometriosis and ovarian tumors; 4. The maximum diameter of leiomyoma is greater than or equal to 5cm; 5. Suspected malignant tumor, such as sarcoma; 6. Those with language communication barriers and unable to cooperate with sedative and analgesic programs; 7. Abdominal scarring, when diagnosed by ultrasound transabdominal scan, has obvious sound attenuation (more than 10mm range).
References
Publications (0)
Data not yet available