Effect of Foot Reflexology on Preeclampsia

Mild Pre-eclampsia Clinical Trial

Official title:

Effect of Foot Reflexology on Preeclampsia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05888896
• Other study ID #: p.t.REC/012/003568
• Status: Recruiting
• Phase: N/A
• Start date: June 9, 2023
• Est. completion date: September 20, 2023

Study information

• Verified date: June 2023
• Source: Cairo University
• Contact: Abeer Ali, lecturer
• Phone: 01142602929
• Email: abeer_ali96[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 20, 2023
• Est. primary completion date: August 9, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 36 Years

Eligibility

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.

Related Conditions & MeSH terms

• Eclampsia
• Mild Pre-eclampsia
• Pre-Eclampsia

Intervention

Other:
• methyldopa tablets 250mg
patients will be taken methyldopa tablets 250mg in the morning orally with a lot of water after breakfast daily and this medication continues for 8 weeks
• methyldopa tablets 250mg + foot reflexology
patients will receive methyldopa tablets 250mg in oral way once daily per 8 weeks and patients will receive foot reflexology two sessions per week, every session will last for 30 minutes and sessions will last for 8 weeks.

Locations

Country	Name	City	State
Egypt	Abeer Ali Ahmed Mansour	Assiut	Assuit

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean arterial blood pressure	the scale that will be used; the Mercury Pressure and Stethoscope; each patient will measured blood pressure before and after treatment	8 weeks
Secondary	Overall quality of life questionnaire	World Health Organization Quality of Life Questionnaire will be used to determine quality of life before and after treatment for all patients	8 weeks
Secondary	Serum cortisol	blood sample will be used to measure level of cortisol before and after treatment	8 weeks
Secondary	Proteinuria	Urine reagent strip devices (dipsticks) will be used to discover it in urine before and after treatment	8 weeks