Effect of Foot Reflexology on Preeclampsia

Not Applicable

Recruiting

• Conditions: Mild Pre-eclampsia
• Interventions: Other: methyldopa tablets 250mg; Other: methyldopa tablets 250mg + foot reflexology

• Registration Number: NCT05888896
• Lead Sponsor: Cairo University

Brief Summary

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

Detailed Description

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).

Study Timeline

• Study First Submitted: 2023-05-25
• Study First Submitted QC: 2023-05-25
• Status Verified: 2023-06
• Study First Posted: 2023-06-05
• Study Start: 2023-06-09
• Primary Completion: 2023-08-09
• Last Update Submitted: 2023-09-19
• Study Completion: 2023-09-20
• Last Update Posted: 2023-09-21

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• Their ages were ranged between 20-36 years old.
• Their body mass index was not exceeding 35 kg/m2.
• All women were diagnosed as mild preeclampsia.
• All women were primipara and multipara.

Exclusion Criteria

• 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\m2.
• Severe preeclampsia.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
anti-hypertensive drugs	methyldopa tablets 250mg	Methyldopa tablets 250 mg will be used oral to reduce hypertension
anti-hypertensive drugs+foot reflexology	methyldopa tablets 250mg + foot reflexology	Methyldopa tablets 250 mg and foot reflexology sessions for 8 weeks ( 30 min 2 times per week) will be used to reduce hypertension

Primary Outcome Measures

Name	Time	Method
Mean arterial blood pressure	8 weeks	the scale that will be used; the Mercury Pressure and Stethoscope; each patient will measured blood pressure before and after treatment

Secondary Outcome Measures

Name	Time	Method
Overall quality of life questionnaire	8 weeks	World Health Organization Quality of Life Questionnaire will be used to determine quality of life before and after treatment for all patients
Proteinuria	8 weeks	Urine reagent strip devices (dipsticks) will be used to discover it in urine before and after treatment
Serum cortisol	8 weeks	blood sample will be used to measure level of cortisol before and after treatment

Trial Locations

Locations (1)

Abeer Ali Ahmed Mansour; 🇪🇬 Assiut, Assuit, Egypt