Effect of Foot Reflexology on Preeclampsia

Sponsor
Cairo University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05888896
Collaborator
(none)
60
1
2
2.4
25.4

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: methyldopa tablets 250mg
  • Other: methyldopa tablets 250mg + foot reflexology
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
anti-hypertensive drugs and foot reflexologyanti-hypertensive drugs and foot reflexology
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
double( Participants, outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effect of Foot Reflexology on Preeclampsia
Anticipated Study Start Date :
Jun 9, 2023
Anticipated Primary Completion Date :
Aug 9, 2023
Anticipated Study Completion Date :
Aug 20, 2023

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    2. Serum cortisol [8 weeks]

      blood sample will be used to measure level of cortisol before and after treatment

    3. Proteinuria [8 weeks]

      Urine reagent strip devices (dipsticks) will be used to discover it in urine before and after treatment

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 36 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Abeer Ali Ahmed Mansour Assiut Assuit Egypt 71511

    Sponsors and Collaborators

    • Cairo University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Abeer Ali Ahmed Mansour, Principal Investigator, Cairo University
    ClinicalTrials.gov Identifier:
    NCT05888896
    Other Study ID Numbers:
    • p.t.REC/012/003568
    First Posted:
    Jun 5, 2023
    Last Update Posted:
    Jun 12, 2023
    Last Verified:
    Jun 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Abeer Ali Ahmed Mansour, Principal Investigator, Cairo University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 12, 2023