Constipation Insoles
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 139
- 试验地点
- 1
- 主要终点
- Constipation Severity Scale
研究概览
简要总结
Constipation is a common symptom among patients receiving palliative care and significantly affects their quality of life. Effective management of constipation requires both pharmacological and non-pharmacological approaches. Reflexology has been increasingly used as a complementary method for constipation management; however, factors such as the need for a trained reflexology specialist, time limitations, and financial constraints may limit patients' access to this intervention. To overcome these barriers, a constipation insole based on reflexology principles has been developed, which can be easily used by patients either at home or in clinical settings.
This study was designed as a randomized controlled experimental trial to evaluate the effectiveness of a constipation insole in the management of constipation in patients receiving palliative care. During the first week of the study, no intervention was applied in order to assess participants' baseline bowel habits. Starting from the second week, patients in the experimental group were instructed to walk with the constipation insole for 20 minutes per day for a total of four weeks. Patients in the control group were instructed to walk for 20 minutes per day for the same duration, without using the insole.
At baseline, data were collected using the Patient Identification Form and the General Comfort Scale. Throughout the study period, bowel function and constipation-related outcomes were monitored using standardized measurement tools. The Constipation Assessment Scale was planned to be administered every three days, the Constipation Severity Scale daily, and the Bristol Stool Consistency Scale at each defecation. The General Comfort Scale was planned to be re-administered on the 28th day of the intervention period.
The findings obtained from this study are expected to provide evidence regarding the potential role of constipation insoles as a complementary intervention in constipation management for patients in palliative care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who volunteer to participate in the study and are over 18 years of age,
- •Patients without any cognitive, mental, or verbal communication impairments,
- •Patients receiving palliative care,
- •Patients with constipation,
- •Patients with fewer than 3 bowel movements per week and/or at least one of the following constipation problems (straining during bowel movements, hard stools, feeling of incomplete emptying, gas/bloating, pressure/feeling of needing to defecate in the rectum).
排除标准
- •Individuals with peripheral neuropathy,
- •impaired foot skin integrity,
- •flat feet or any foot deformity,
- •and those using complementary treatments such as abdominal massage, acupressure, or acupuncture to relieve constipation were excluded from the study.
研究组 & 干预措施
Experimental Group
Patients in the experimental group were instructed to walk with the constipation insole for 20 minutes a day for four weeks, starting from the second week
干预措施: constipation insole (Behavioral)
Experimental Group
Patients in the experimental group were instructed to walk with the constipation insole for 20 minutes a day for four weeks, starting from the second week
干预措施: Walk (Behavioral)
Control Group
Patients in the control group were only instructed to walk for 20 minutes a day for four weeks.
干预措施: Walk (Behavioral)
结局指标
主要结局
Constipation Severity Scale
时间窗: First week
The Large Bowel Syndrome (LBS) consists of 16 questions in total and was developed to determine the frequency, intensity, and difficulty during defecation. The LBS comprises three sub-dimensions: "large bowel sluggishness," "fecal obstruction," and "pain." The highest possible score on the scale is 73. Scores for fecal obstruction range from 0-28, for large bowel sluggishness from 0-29, and for pain from 0-16.
Constipation Severity Scale
时间窗: second week
The Large Bowel Syndrome (LBS) consists of 16 questions in total and was developed to determine the frequency, intensity, and difficulty during defecation. The LBS comprises three sub-dimensions: "large bowel sluggishness," "fecal obstruction," and "pain." The highest possible score on the scale is 73. Scores for fecal obstruction range from 0-28, for large bowel sluggishness from 0-29, and for pain from 0-16.
Constipation Severity Scale
时间窗: third week
The Large Bowel Syndrome (LBS) consists of 16 questions in total and was developed to determine the frequency, intensity, and difficulty during defecation. The LBS comprises three sub-dimensions: "large bowel sluggishness," "fecal obstruction," and "pain." The highest possible score on the scale is 73. Scores for fecal obstruction range from 0-28, for large bowel sluggishness from 0-29, and for pain from 0-16.
Constipation Severity Scale
时间窗: fifth week
The Large Bowel Syndrome (LBS) consists of 16 questions in total and was developed to determine the frequency, intensity, and difficulty during defecation. The LBS comprises three sub-dimensions: "large bowel sluggishness," "fecal obstruction," and "pain." The highest possible score on the scale is 73. Scores for fecal obstruction range from 0-28, for large bowel sluggishness from 0-29, and for pain from 0-16.
Constipation Assessment Scale
时间窗: Baseline
This is a scale consisting of 8 items in total, which inquires about abdominal bloating, gas, bowel sounds, fecal incontinence, feeling of fullness/pressure in the rectum, pain during defecation, small or lumpy stools, and the presence of an urgent need to defecate but inability to do so.
Constipation Assessment Scale
时间窗: third day
This is a scale consisting of 8 items in total, which inquires about abdominal bloating, gas, bowel sounds, fecal incontinence, feeling of fullness/pressure in the rectum, pain during defecation, small or lumpy stools, and the presence of an urgent need to defecate but inability to do so.
Constipation Assessment Scale
时间窗: sixth day
This is a scale consisting of 8 items in total, which inquires about abdominal bloating, gas, bowel sounds, fecal incontinence, feeling of fullness/pressure in the rectum, pain during defecation, small or lumpy stools, and the presence of an urgent need to defecate but inability to do so.
Constipation Assessment Scale
时间窗: ninth day
This is a scale consisting of 8 items in total, which inquires about abdominal bloating, gas, bowel sounds, fecal incontinence, feeling of fullness/pressure in the rectum, pain during defecation, small or lumpy stools, and the presence of an urgent need to defecate but inability to do so.
Constipation Assessment Scale
时间窗: twelfth day
This is a scale consisting of 8 items in total, which inquires about abdominal bloating, gas, bowel sounds, fecal incontinence, feeling of fullness/pressure in the rectum, pain during defecation, small or lumpy stools, and the presence of an urgent need to defecate but inability to do so.
Constipation Assessment Scale
时间窗: fifteenth day
This is a scale consisting of 8 items in total, which inquires about abdominal bloating, gas, bowel sounds, fecal incontinence, feeling of fullness/pressure in the rectum, pain during defecation, small or lumpy stools, and the presence of an urgent need to defecate but inability to do so.
Constipation Assessment Scale
时间窗: eighteenth day
This is a scale consisting of 8 items in total, which inquires about abdominal bloating, gas, bowel sounds, fecal incontinence, feeling of fullness/pressure in the rectum, pain during defecation, small or lumpy stools, and the presence of an urgent need to defecate but inability to do so.
Constipation Assessment Scale
时间窗: twenty-first day
This is a scale consisting of 8 items in total, which inquires about abdominal bloating, gas, bowel sounds, fecal incontinence, feeling of fullness/pressure in the rectum, pain during defecation, small or lumpy stools, and the presence of an urgent need to defecate but inability to do so.
Constipation Assessment Scale
时间窗: twenty-fourth day
This is a scale consisting of 8 items in total, which inquires about abdominal bloating, gas, bowel sounds, fecal incontinence, feeling of fullness/pressure in the rectum, pain during defecation, small or lumpy stools, and the presence of an urgent need to defecate but inability to do so.
Constipation Assessment Scale
时间窗: twenty-seventh day
This is a scale consisting of 8 items in total, which inquires about abdominal bloating, gas, bowel sounds, fecal incontinence, feeling of fullness/pressure in the rectum, pain during defecation, small or lumpy stools, and the presence of an urgent need to defecate but inability to do so.
Constipation Assessment Scale
时间窗: thirtieth day
This is a scale consisting of 8 items in total, which inquires about abdominal bloating, gas, bowel sounds, fecal incontinence, feeling of fullness/pressure in the rectum, pain during defecation, small or lumpy stools, and the presence of an urgent need to defecate but inability to do so.
Overall Comfort Scale
时间窗: Baseline
It is a scale developed to assess an individual's need for comfort. In the evaluation of the scale, negatively worded items are reverse-coded and summed together with the positively worded items. The highest possible total score on the scale is 192, while the lowest possible total score is 48. The total score obtained is divided by the number of items on the scale to calculate the mean score, which is expressed on a scale ranging from 1 to 4. A score of 1 indicates low comfort, whereas a score of 4 indicates high comfort.
Overall Comfort Scale
时间窗: thirty-fifth day
It is a scale developed to assess an individual's need for comfort. In the evaluation of the scale, negatively worded items are reverse-coded and summed together with the positively worded items. The highest possible total score on the scale is 192, while the lowest possible total score is 48. The total score obtained is divided by the number of items on the scale to calculate the mean score, which is expressed on a scale ranging from 1 to 4. A score of 1 indicates low comfort, whereas a score of 4 indicates high comfort.
次要结局
未报告次要终点
研究者
DİLEK YILDIRIM
Associate Professor Dr.
Istanbul Aydın University