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临床试验/NCT06877871
NCT06877871已完成不适用

Combined Effects of Whole Body Vibration and Abdominal Binders on Outcome Measures of Constipation in Postnatal Women

Riphah International University1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2023年12月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
54
试验地点
1
主要终点
Patient assessment of constipation symptoms (PAC-SYM) Questionnaire It

研究概览

简要总结

Constipation is a prevalent issue among postnatal women, often resulting in significant discomfort and reduced quality of life. Traditional treatments like dietary adjustments and laxatives frequently provide only temporary relief and may lead to dependency. Whole-body vibration therapy and abdominal binders have emerged as promising non-invasive interventions for improving bowel function and relieving constipation.

详细描述

Constipation is a complex condition arising due to many interrelated causes. Dietary inadequacies, most notably for fiber or fluid, often constitute a centerpiece of constipation. But other lifestyle factors including lack of movement and irregular bowel movements are also to blame. Known conditions affecting the gut motility, from medical perspective, include irritable bowel syndrome (IBS), diabetes, hypothyroidism, and neurological disorders including Parkinson's disease. Often listed as a side effect in medications such as opiates, antacids and antidepressants for example. Additionally, gut brain axis demonstrates that psychological aspects play a substantial part in the well being of the gut, since stress and anxiety frequently make matters worse. It is important to understand the causes of constipation to develop treatments.It is usually described as occurring less than three times per week, difficult to pass stools or passage of stools that does not feel satisfactory. Whereas, acute constipation can be often attributed to alteration in diet and water intake or stress, the chronic constipation is a long-standing pathological entity which can negatively affect the quality of life. Whole body vibration therapy (WBV) is a therapeutic modality that utilizes mechanical vibrations to excite muscle, nerve and tissue structures in the body. WBV is typically administered on a vibrating platform where the device is either controlled to deliver vibrations at specified frequencies and amplitudes as the individual performs a standing, sitting, or lying position. The vibrations produce rapid, involuntary muscle contractions- and result in a similar exercising effect without the impact to your body. Abdominal binders are conventionally used for physical support but recent evidence supports their use in improving bowel function as increased abdominal muscle recruitment and intra-abdominal pressure, both integral to a healthy peristaltic push.

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
Single (Investigator)

入排标准

年龄范围
22 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Females age 22-35 years
  • •Females underwent C-section were included in the study
  • •Participants who had severe constipation
  • •Primary gravida
  • •Women who had 6 months of Postpartum period
  • •Single fetus pregnancy

排除标准

  • •Females who had normal delivery were excluded
  • •History of episiotomy
  • •Participants taking laxative were excluded
  • •History of post cesarean abdominal suture infections

研究组 & 干预措施

Experimental group: Whole body vibration

Experimental

WBV was developed initially for fitness and physical rehabilitation and has been moving into other areas of healthcare such as pain management and neurological recovery and improving circulation. whole body vibration (WBV) therapy for the body eases the physical functions of muscular and circulatory. Additionally, mechanical aids (e.g. abdominal binders) have been explored as support for abdominal region and proper posture, which in turn secondarily aid gastrointestinal function

干预措施: WBV utilizes mechanical vibrations to excite muscle, nerves. Abdominal binders are to help patients who have suffered abdominal trauma to stabilize core muscles, reduce pain, and improve mobility (Other)

Experimental group: Abdominal binders

Experimental

Abdominal binders are designed primarily to help patients who have suffered abdominal trauma to stabilize core muscles, reduce pain, and improve mobility. Improved posture, better breathing and a reduction of strain on the lower back are also aided by creating gentle pressure on the abdomen. Abdominal binders are conventionally used for physical support but recent evidence supports their use in improving bowel function as increased abdominal muscle recruitment and intra-abdominal pressure, both integral to a healthy peristaltic push.

干预措施: WBV utilizes mechanical vibrations to excite muscle, nerves. Abdominal binders are to help patients who have suffered abdominal trauma to stabilize core muscles, reduce pain, and improve mobility (Other)

结局指标

主要结局

Patient assessment of constipation symptoms (PAC-SYM) Questionnaire It

时间窗: A total of 18 sessions were conducted over a period of 6 weeks,

It is frequently used in clinical trials of constipation. It is an important tool for assessing the severity of patient reported symptoms of constipation. The 12-item questionnaire is divided into three symptom sub scales: abdominal (four items); rectal (three items); and stool (five items). Items are scored on 5-point Likert scales, with scores ranging from 0 to 4 (0 = 'symptom absent', 1 = 'mild', 2 = 'moderate', 3 = 'severe' and 4 = 'very severe').

Patient assessment of constipation quality of life (PAC-QOL) Questionnaire

时间窗: A total of 18 sessions were conducted over a period of 6 weeks,

The PAC-QOL questionnaire is sub categorized to 4 items on physical discomfort, 8 items on psycho social discomfort, 5 items on treatment satisfaction, and finally 11 items on worries and discomfort. Response choice is a Likert scale from 0 to 4.

Modified constipation assessment scale (MCAS)

时间窗: A total of 18 sessions were conducted over a period of 6 weeks,

It is used to assess bowel function. It consists of a 3-point summated rating scale (0 = no problem ; 1 = some problem ; 2 = severe problem ) resulting in a total score that ranges from 0 ( no constipation ) to 16 ( severe constipation ).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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