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Trial Title:
Establishment of a Decision Aid Tool for Asymptomatic Small Leiomyoma and Analysis of Influencing Factors for Clinical Decision-making Using HIFU
NCT ID:
NCT05500118
Condition:
Leiomyoma, Uterine
High-Intensity Focused Ultrasound Ablation
Patients Decision Aids
Conditions: Official terms:
Leiomyoma
Myofibroma
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Patients Decision Aids
Description:
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.
Arm group label:
communication with PADs
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.
Criteria for eligibility:
Study pop:
18-55 years old woman diagnosed with uterine fibroids and without clinical symptoms
Sampling method:
Non-Probability Sample
Criteria:
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).
Gender:
Female
Minimum age:
18 Years
Maximum age:
55 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shenzhen Maternal and Child Health Hospital
Address:
City:
Shenzhen
Zip:
518000
Country:
China
Status:
Recruiting
Contact:
Last name:
Ping Jin, Professor
Phone:
13925206896
Email:
13925206896@163.com
Start date:
August 31, 2022
Completion date:
August 31, 2027
Lead sponsor:
Agency:
Shenzhen Maternity & Child Healthcare Hospital
Agency class:
Other
Source:
Shenzhen Maternity & Child Healthcare Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05500118
