Three-Dimensional Breathing Patterns in Postpartum Stress Urinary Incontinence
NCT ID: NCT06623617
Last Updated: 2024-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
210 participants
INTERVENTIONAL
2024-11-01
2025-02-28
Brief Summary
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Participants will:
* Receive one-on-one verbal health education covering the causes and risk factors of PPSUI, benefits and precautions of pelvic floor exercises and breathing, and implementation methods.
* Engage in app-based three-dimensional breathing training and learn to use a biofeedback pressure device at home for proper and effective training. They will also be guided to log their daily training, manually inputting data such as duration and frequency. A virtual assistant will provide real-time feedback based on this data, including encouragement and adjustments to training intensity.
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Detailed Description
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1. Establish a dedicated technical team for system testing and quality control to ensure stable operation of the APP and accurate data.
2. Regularly update and optimize the virtual characters to guarantee the best user experience.
Data Security and Privacy Protection
1. Ensure that all user data is encrypted to protect user privacy and data security.
2. Comply with relevant regulations and standards to ensure the lawful use and protection of user data.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intervention Group：three-dimensional breathing training group
Engage in app-based three-dimensional breathing training and learn to use a biofeedback pressure device at home for proper and effective training. They will also be guided to log their daily training, manually inputting data such as duration and frequency. A virtual assistant will provide real-time feedback based on this data, including encouragement and adjustments to training intensity.
Three-dimensional breathing training
Engage in app-based three-dimensional breathing training and learn to use a biofeedback pressure device at home for proper and effective training. They will also be guided to log their daily training, manually inputting data such as duration and frequency. A virtual assistant will provide real-time feedback based on this data, including encouragement and adjustments to training intensity.
control group：Health education
Provide participants with health education, which is conducted one-on-one by researchers during the recruitment of mothers. The content includes the etiology and risk factors of PPSUI (Pelvic Organ Prolapse during Straining), the benefits and precautions of pelvic floor muscle exercises and breathing techniques, as well as the implementation methods.
Control group：Health education
The control group received health education, which was conducted one-on-one by researchers during the recruitment of mothers. The content included the etiology and risk factors of PPSUI (Prolapse of Pelvic Organs during Straining), the benefits and precautions of pelvic floor muscle exercises and breathing, as well as the implementation methods.
control group：Health education
Provide participants with health education, which is conducted one-on-one by researchers during the recruitment of mothers. The content includes the etiology and risk factors of PPSUI (Pelvic Organ Prolapse during Straining), the benefits and precautions of pelvic floor muscle exercises and breathing techniques, as well as the implementation methods.
Interventions
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Three-dimensional breathing training
Engage in app-based three-dimensional breathing training and learn to use a biofeedback pressure device at home for proper and effective training. They will also be guided to log their daily training, manually inputting data such as duration and frequency. A virtual assistant will provide real-time feedback based on this data, including encouragement and adjustments to training intensity.
control group：Health education
Provide participants with health education, which is conducted one-on-one by researchers during the recruitment of mothers. The content includes the etiology and risk factors of PPSUI (Pelvic Organ Prolapse during Straining), the benefits and precautions of pelvic floor muscle exercises and breathing techniques, as well as the implementation methods.
Eligibility Criteria
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Inclusion Criteria
2. Postpartum: 42 to 49 days
3. Diagnosed with pure postpartum stress urinary incontinence (PPSUI) by an experienced obstetrician/gynecologist during the first postpartum check-up, according to the International Continence Society (ICS) standards.
Exclusion Criteria
2. Cesarean section
3. Multiparous women
4. Pathological conditions or deformities of the spine
5. History of lumbopelvic surgery
6. Urogenital prolapse of grade 2 or higher
7. Professional athletes
8. Severe cardiopulmonary conditions during pregnancy or postpartum
9. Neurological diseases or cognitive impairments
10. Individuals unable to meet study requirements
20 Years
35 Years
FEMALE
No
Sponsors
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Jie Li
OTHER
Responsible Party
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Jie Li
Nurse
Principal Investigators
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Wenzhi First Name: （Wenzhi） Middle initial: （） Degree: （Professor）
Role: STUDY_CHAIR
Shenzhen Hospital of Southern Medical University
Central Contacts
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Jie First Name: （jie） Middle initial: （） Degree: （Ph.D. candidate）
Role: CONTACT
Other Identifiers
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JieLi
Identifier Type: -
Identifier Source: org_study_id
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