We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT05500118
Recruitment Status : Recruiting
First Posted : August 12, 2022
Last Update Posted : August 12, 2022
Information provided by (Responsible Party):
Yu Dai, Shenzhen Maternity & Child Healthcare Hospital

Brief 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.

Condition or disease Intervention/treatment
Leiomyoma, Uterine High-Intensity Focused Ultrasound Ablation Patients Decision Aids Other: Patients Decision Aids

Layout table for study information
Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Establishment of a Decision Aid Tool for Asymptomatic Small Leiomyoma and Analysis of Influencing Factors for Clinical Decision-making Using HIFU
Estimated Study Start Date : August 31, 2022
Estimated Primary Completion Date : August 31, 2024
Estimated Study Completion Date : August 31, 2027

Group/Cohort Intervention/treatment
communication without PADs
We use traditional communication ways to discuss the conditions with patients.
communication with PADs
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.
Other: Patients 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.

Primary Outcome Measures :
  1. Patient satisfaction after using PDAs [ Time Frame: 6-12 months ]
    The patients in PDAs will undertake the treatment by PDAs. And we will collect the satisfaction after 12 months.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
18-55 years old woman diagnosed with uterine fibroids and without clinical symptoms

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05500118

Layout table for location contacts
Contact: Yu Dai, Associate Professor 13828718985 daiyu829@163.com

Layout table for location information
China, Guangdong
Shenzhen Maternal and Child Health Hospital Recruiting
Shenzhen, Guangdong, China, 518000
Contact: Ping Jin, Professor    13925206896    13925206896@163.com   
Sponsors and Collaborators
Shenzhen Maternity & Child Healthcare Hospital
Layout table for additonal information
Responsible Party: Yu Dai, Associate Professor, Shenzhen Maternity & Child Healthcare Hospital
ClinicalTrials.gov Identifier: NCT05500118    
Other Study ID Numbers: 2021KFKT030
First Posted: August 12, 2022    Key Record Dates
Last Update Posted: August 12, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Connective Tissue
Connective Tissue Diseases