A Randomized Controlled Trial of Perineal Self-Acupressure for Chronic Constipation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Patient Assessment of Constipation Quality of Life Questionnaire
研究概览
简要总结
The primary aim of this study is to test a non-medicinal technique for chronic constipation. The core of the technique is to have subjects repeatedly press on and massage their perineum before defecation to fragment and soften the stool before it passes the lower rectum and anus. The technique will be evaluated as a complementary treatment to standard treatment of constipation (patient educational materials about treatments such as stool softeners, laxatives fiber supplements, and increased exercise). Although this technique has been studied for other conditions (for example in pregnant women to prevent birthing-related injuries), and it is recommended anecdotally by some physicians, this would be the first time it will be studied for chronic constipation in a randomized, controlled clinical trial.
$50 dollars in compensation is provided for about an hour of participant's time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have experienced the following symptoms for at least three months:
- •Straining during at least 25 percent of defecations
- •Lumpy or hard stools in at least 25 percent of defecations
- •Sensation of incomplete evacuation for at least 25 percent of defecations
- •Sensation of anorectal obstruction/blockage for at least 25 percent of defecations
- •Manual maneuvers to facilitate at least 25 percent of defecations (eg, digital evacuation, support of the pelvic floor)
- •Fewer than three defecations per week
- •Must have experienced one or more of those symptoms at least six months ago.
排除标准
- •Younger than 18 years old.
- •Pregnant women.
- •Significant weight loss (more than 10% of usual body weight in the preceding 6 months).
- •History of blood mixed in stool.
研究组 & 干预措施
Perineal Self-Acupressure
Participants in this group (intervention group) will receive education in perineal self-acupressure in addition to education in conventional treatment options for constipation.
干预措施: Perineal Self-Acupressure (Behavioral)
Educational Control
Participants in this group (the control group) will receive education in conventional treatment options for chronic constipation.
干预措施: Educational Control (Behavioral)
结局指标
主要结局
Patient Assessment of Constipation Quality of Life Questionnaire
时间窗: 1 month
Constipation related health-related quality of life by means of Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL).
次要结局
- Modified Bowel Function Index and Hemorrhoid Questionnaire(1 month)
- SF-12(1 month)