Effect of 6 Weeks of Whole-body Vibration in Treatment of Postnatal Constipation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL)
研究概览
简要总结
Background: Postpartum constipation is a common problem affecting postpartum mothers. Aim: To determine whether Whole Body Vibration is effective in treatment of postnatal women constipation. Design: The study was designed as a prospective, randomized, single-blind, pre-post-test, controlled trial.
HYPOTHESES:
It will be hypothesized that:
It was hypothesized that whole-body vibration has no or limited effect in treatment of postnatal constipation RESEARCH QUESTION: Does whole-body vibration has an effect in treatment of postnatal constipation?
详细描述
Methods: Group A received whole-body vibration, pelvic floor exercise and static abdominal exercises interventions for six weeks and group B received pelvic floor exercises and static abdominal exercises in addition to diet instructions in both groups. Constipation symptom questionnaire and patient assessment of constipation quality of life questionnaire is applied before and after treatment.
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
- Double (Participant, 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
- •The participants age ranged from 22 to 35 years old
- •with vaginal delivery
- •complain from postnatal constipation from (2 - 6 weeks) post-delivery
- •had body mass index (BMI) ranged from 30 to 32 kg/m2.
排除标准
- •Participants were excluded if they:
- •had diabetes, hypertension, cardiac diseases.
- •Women who had history of inflammatory bowel disease and abnormalities of anal region or anal fissure
- •women who had history of bowel surgery (other than appendectomy),
- •patients who had endocrine disease or digestive tract disease
- •history of neurological or musculoskeletal disorder.
结局指标
主要结局
Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL)
时间窗: Change from Baseline then after 6 weeks of intervention.
PAC-QOL questionnaire comprises 28 questions and depending on the factor analysis structure, the tool comprises four subscales, including "Physical discomfort (question 1-4)," "Psychosocial discomfort (question 5-12)," "Worries and concerns (question 13-23)," and "Satisfaction (question 24-28)." Similar to the Likert scale, each option is scored on a scale of 0-4 (least to the greatest effect), and higher scores indicate a worst quality of life. However, reverse coding was required in questions 18, 25, 26, 27, and 28 because they were positive questions, whereas the other 23 questions were negative ones.
Patient Assessment of Constipation-Symptom questionnaire
时间窗: Change from Baseline then after 6 weeks of intervention.
PAC-SYM is composed of three domains: abdominal symptoms, 4 items; rectal symptoms, 3 items; and stool symptoms, 5 items. Wording was as follows: ''How severe have each of these symptoms been in the last two weeks?'' Items are rated on a 5-point (0-4) Likert scale. Responses are scored as 0 = absence of symptom, 1 = mild, 2 = moderate, 3 = severe and 4 = very severe. The ABD, REC and STO domain scores are the mean scores of each domain. Constipation was defined by the responses to the following questions: ''Have laxatives been taken during this period?'' (if ''yes'' then CC = 0: end of scoring); ''Have stools been passed on 3 or more days/week on average?'' (if ''yes'' then F = 0; if ''no'' then F = 1: in either case, and for subsequent questions, scoring is continued); ''Was stool passage difficult or painful?'' and ''Was stool consistency predominantly hard?'' The CC score indicates either constipation (CC = 2 or 3) or non-constipation (CC = 0 or 1).
次要结局
未报告次要终点
研究者
Eman Mohamed othman
professor
Cairo University