Community Based Health Education for Prevention of Pelvic Floor Dysfunction in Fertile Women in Rural China: Study Protocol for a Non-randomised Cluster Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,139
- 试验地点
- 1
- 主要终点
- The score of Pelvic Floor Distress Inventory-short form 20 (PFDI-20)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Married women who are 18-65 years old
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Health education intervention (Behavioral)
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.
结局指标
主要结局
The score of Pelvic Floor Distress Inventory-short form 20 (PFDI-20)
时间窗: 12 weeks after the start of intervention
This participant completed questionnaire comprises three subscales with scores ranging from 0 to 100: the Pelvic Organ Prolapse Distress Inventory-6 assessing prolapse symptoms, the ColoRectal-Anal Distress Inventory-8 assessing colorectal/anal symptoms, and the Urinary Distress Inventory-6 assessing urinary symptoms. A higher PFDI-20 score (sum of three subscale scores, range 0-300) indicates a higher symptom burden.
The change in the incidence of pelvic floor dysfunction symptoms
时间窗: 12 weeks after the start of intervention
It is defined by the proportion of people who get a PFDI-20 score not equal to 0.
次要结局
- The score of Prolapse and Incontinence Knowledge Quiz (PIKQ)(12 weeks after the intervention)
- The score of Pelvic Floor Impact Questionnaire-7 (PFIQ-7)(12 weeks after the intervention)
- Self-reported monthly working days by questionnaire (day)(12 weeks after the intervention)
- Self-reported monthly personal income by questionnaire (Yuan)(12 weeks after the intervention)
研究者
Yu Sun
Ph.D., Assistant Director, PKU China Center for Health Economic Research (CCHER)
Peking University