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临床试验/NCT05888896
NCT05888896招募中不适用

Effect of Foot Reflexology on Preeclampsia

Cairo University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年6月9日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
2
主要终点
Mean arterial blood pressure

研究概览

简要总结

the aim of this study to investigate the effect of foot reflexology on mild preeclampsia during pregnancy

详细描述

Preeclampsia is defined as arterial hypertension identified for the first time after the 20th week associated with proteinuria. It affects 5% to 7% of all pregnant women. It is more common in primigravida women, women with previous early onset preeclampsia, in age greater than 40 years, previous history of preeclampsia, pre-pregnancy obesity, women who become pregnant with donor eggs, embryo donation and donor insemination. It is responsible for over 70 000 maternal deaths and 500 000 fetal deaths worldwide every year. There are many risk factors for it as: Hypertension, diabetes mellitus, proteinuria, obesity, family history, null parity, multiple pregnancies, use of contraception, older women conception (> 40) and thrombotic vascular disease,edema, renal failure, liver failure and hellp syndrome.Complementary therapies such as massage and foot reflexology are used with patients of preeclampsia, it is to normalize the body's function, break down tension, alleviate stress, improve nerve function and blood supply throughout the body. this trial has two groups; one will receive anti-hypertensive drugs and the second will receive anti-hypertensive drugs+foot reflexology sessions for 8 weeks (30 min, 2 session/ week).

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, Outcomes Assessor)

盲法说明

double( Participants, outcomes Assessor)

入排标准

年龄范围
20 Years 至 36 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Their ages were ranged between 20-36 years old.
  • Their body mass index was not exceeding 35 kg/m
  • All women were diagnosed as mild preeclampsia.
  • All women were primipara and multipara.

排除标准

  • Any fractures in foot.
  • Foot ulcer & infection.
  • Open skin wound in foot.
  • History of stroke.
  • Women less than 20 years and more than 36 years.
  • BMI more than 35 Kg\m
  • Severe preeclampsia.

结局指标

主要结局

Mean arterial blood pressure

时间窗: 8 weeks

the scale that will be used; the Mercury Pressure and Stethoscope; each patient will measured blood pressure before and after treatment

次要结局

  • Proteinuria(8 weeks)
  • Overall quality of life questionnaire(8 weeks)
  • Serum cortisol(8 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Abeer Ali Ahmed Mansour

Principal Investigator

Cairo University

研究点 (2)

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