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

NCT ID: NCT05595967

Last Updated: 2022-11-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 1139 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-18
• Study Completion Date: 2023-08-05

Brief Summary

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.

Conditions

Pelvic Floor Dysfunction

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Health education intervention

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.

Group Type: ACTIVE_COMPARATOR

Health education intervention

Intervention Type: BEHAVIORAL

Both the two session contains modules focusing on heath related knowledge and pelvic floor muscle exercise. Both two session will be delivered by primary healthcare women workers in small groups (about 20 women per group). The local healthcare workers are responsible for making appointment with each participant through group activities. Each participant will receive a healthy calendar practice to record the number of exercises per day which will be supervised by primary healthcare workers. All healthcare workers are required to attend a full-day workshop organized base on the scheme and teaching materials developed by our research team. The contents of the workshop include: (1) introduction of pelvic floor dysfunction; (2) risk factors and prevention of pelvic floor dysfunction; (3) kegel movement; (4) methods of dealing with severe illness; (5) a standard procedure of group activities or one-on-one activities; (6) skills needed for the delivery of health education intervention.

Control without intervention

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Health education intervention

Both the two session contains modules focusing on heath related knowledge and pelvic floor muscle exercise. Both two session will be delivered by primary healthcare women workers in small groups (about 20 women per group). The local healthcare workers are responsible for making appointment with each participant through group activities. Each participant will receive a healthy calendar practice to record the number of exercises per day which will be supervised by primary healthcare workers. All healthcare workers are required to attend a full-day workshop organized base on the scheme and teaching materials developed by our research team. The contents of the workshop include: (1) introduction of pelvic floor dysfunction; (2) risk factors and prevention of pelvic floor dysfunction; (3) kegel movement; (4) methods of dealing with severe illness; (5) a standard procedure of group activities or one-on-one activities; (6) skills needed for the delivery of health education intervention.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Peking University

OTHER

Sponsor Role: lead

Responsible Party

Yu Sun

Ph.D., Assistant Director, PKU China Center for Health Economic Research (CCHER)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Guoen Liu, PhD

Role: PRINCIPAL_INVESTIGATOR

Peking University

Locations

Peking University China Center for Health Economic Research

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

PekingUni_Liangshan

Identifier Type: -

Identifier Source: org_study_id