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Effect of Foot Reflexology on Preeclampsia

Primary Purpose

Mild Pre-eclampsia

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
methyldopa tablets 250mg
methyldopa tablets 250mg + foot reflexology
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Pre-eclampsia focused on measuring Foot reflexology - Preeclampsia - Proteinuria

Eligibility Criteria

20 Years - 36 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Abeer Ali Ahmed MansourRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

anti-hypertensive drugs

anti-hypertensive drugs+foot reflexology

Arm Description

Methyldopa tablets 250 mg will be used oral to reduce hypertension

Methyldopa tablets 250 mg and foot reflexology sessions for 8 weeks ( 30 min 2 times per week) will be used to reduce hypertension

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Serum cortisol
blood sample will be used to measure level of cortisol before and after treatment
Proteinuria
Urine reagent strip devices (dipsticks) will be used to discover it in urine before and after treatment

Full Information

First Posted
May 25, 2023
Last Updated
September 19, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05888896
Brief Title
Effect of Foot Reflexology on Preeclampsia
Official Title
Effect of Foot Reflexology on Preeclampsia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 9, 2023 (Actual)
Primary Completion Date
August 9, 2023 (Actual)
Study Completion Date
September 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Pre-eclampsia
Keywords
Foot reflexology - Preeclampsia - Proteinuria

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
anti-hypertensive drugs and foot reflexology
Masking
ParticipantOutcomes Assessor
Masking Description
double( Participants, outcomes Assessor)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
anti-hypertensive drugs
Arm Type
Experimental
Arm Description
Methyldopa tablets 250 mg will be used oral to reduce hypertension
Arm Title
anti-hypertensive drugs+foot reflexology
Arm Type
Experimental
Arm Description
Methyldopa tablets 250 mg and foot reflexology sessions for 8 weeks ( 30 min 2 times per week) will be used to reduce hypertension
Intervention Type
Other
Intervention Name(s)
methyldopa tablets 250mg
Other Intervention Name(s)
anti-hypertensive drugs
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
methyldopa tablets 250mg + foot reflexology
Other Intervention Name(s)
anti-hypertensive drugs+ foot massage
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean arterial blood pressure
Description
the scale that will be used; the Mercury Pressure and Stethoscope; each patient will measured blood pressure before and after treatment
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Overall quality of life questionnaire
Description
World Health Organization Quality of Life Questionnaire will be used to determine quality of life before and after treatment for all patients
Time Frame
8 weeks
Title
Serum cortisol
Description
blood sample will be used to measure level of cortisol before and after treatment
Time Frame
8 weeks
Title
Proteinuria
Description
Urine reagent strip devices (dipsticks) will be used to discover it in urine before and after treatment
Time Frame
8 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
pregnant female with preeclampsia
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
36 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abeer Ali, lecturer
Phone
01142602929
Email
abeer_ali96@yahoo.com
Facility Information:
Facility Name
Abeer Ali Ahmed Mansour
City
Assiut
State/Province
Assuit
ZIP/Postal Code
71511
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abeer Ali, Lecturer
Phone
01142602929
Email
abeer_ali96@yahoo.com

12. IPD Sharing Statement

Learn more about this trial

Effect of Foot Reflexology on Preeclampsia

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