Community Based Health Education for Prevention of Pelvic Floor Dysfunction in Fertile Women in Rural China

Peking University

Status: Active, not recruiting

Conditions: Pelvic Floor Dysfunction

Treatments: Behavioral: Health education intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05595967

PekingUni_Liangshan

Details and patient eligibility

About

According to the experts in charge of the healthcare department in the Liangshan area, Liangshan is one of the largest Yi inhabited areas in China. Influenced by local culture and production history, most women there are multiparas, with more than one child, and their awareness of postpartum recovery is relatively weak. Therefore, the prevalence and incidence rate of pelvic floor dysfunction diseases is high in the Liangshan area.

In addition, women in the Liangshan area shoulder the responsibility of taking care of family members, farmland, and livestock. They play an important role in family production, which guarantees the opportunity for other family members to go out to work. However, pelvic floor dysfunction can be manifested by persistent pelvic distension, frequent urination, the urgency of urination, difficulty in urination or defecation, and pain or difficulty in sexual intercourse, which decreases the quality of normal life, and the efficiency of production, posing many psychological problems and family contradictions.

There is no research to prove the exact intervention measures that can effectively improve the pelvic floor function of women in Liangshan ethnic minority areas. This study aims to promote the formation of women's healthy living habits and behaviors, improve women's pelvic floor function, and then develop the quality of life and labor output of local women through intervention including health knowledge education and pelvic floor muscle exercise.

Enrollment: 1,139 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Married women who are 18-65 years old

Exclusion criteria

• Women who are unable to attend the person-to-person health education classes at the first and forth month of the intervention;
• Women who have received pelvic floor muscle training, pelvic floor muscle health education, pelvic floor muscle surgery within one year of the baseline survey;
• Women who are planning pregnancy, pregnant, or have delivered a baby in the past 6 months since the baseline survey;
• Women who are unable to understand the instructions or questions from others.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,139 participants in 2 patient groups

Health education intervention

Active Comparator group

Description:

According the data collected in baseline survey, all participants will be divided into two groups: asymptomatic or mildly symptomatic and severe according the risk level of pelvic floor dysfunction. Intervention for high risk of pelvic floor women focus on emphasizing the need for medical care and access to medical resourced. The first intervention will be performed immediately after baseline survey. The second intervention will be repeated with the first one and performed three months after the first intervention. Both the two session contains modules focusing on heath related knowledge and pelvic floor muscle exercise.

Treatment:

Behavioral: Health education intervention

Control without intervention

No Intervention group

Description:

No health education is provided to the participants in the control group so as to investigate the effects of health education. However, materials provided to interventional group will also be sent to the control group after the completion of the study.