Effect of Foot Reflexology on Preeclampsia

September 19, 2023 updated by: Abeer Ali Ahmed Mansour, Cairo University
the aim of this study to investigate the effect of foot reflexology on mild preeclampsia during pregnancy

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Assuit
      • Assiut, Assuit, Egypt, 71511
        • Recruiting
        • Abeer Ali Ahmed Mansour
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: anti-hypertensive drugs
Methyldopa tablets 250 mg will be used oral to reduce hypertension
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
Other Names:
  • anti-hypertensive drugs
Experimental: anti-hypertensive drugs+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
Other: 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.
Other Names:
  • anti-hypertensive drugs+ foot massage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean arterial blood pressure
Time Frame: 8 weeks
the scale that will be used; the Mercury Pressure and Stethoscope; each patient will measured blood pressure before and after treatment
8 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 9, 2023

Primary Completion (Actual)

August 9, 2023

Study Completion (Estimated)

September 20, 2023

Study Registration Dates

First Submitted

May 25, 2023

First Submitted That Met QC Criteria

May 25, 2023

First Posted (Actual)

June 5, 2023

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 19, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • p.t.REC/012/003568

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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