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Foot Reflexology on Premenstrual Syndrome

Primary Purpose

Reflexology, Dietary Modification

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
foot reflexology
dietary modification
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Reflexology

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • their age ranged from 18 to 25 years old
  • their body mass index (BMI) did not exceed 30kg/m2

Exclusion Criteria:

  • Rheumatoid arthritis
  • Bronchial asthma
  • depression
  • anxiety

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    foot reflexology

    dietary modification

    Arm Description

    foot reflexology session which takes about 20 minutes.

    diet must be rich in vitamins.

    Outcomes

    Primary Outcome Measures

    Visual analogue scale
    was used to measure the severity of pain for each female in both groups (A, B) before and after the treatment according to 5 cm calibrated line with 0 (zero) representing no pain and 5 representing worst pain, each female in both groups (A&B) would be asked to mark on the line that represents her level of pain before and after treatment.

    Secondary Outcome Measures

    Premenstrual daily symptoms questionnaire
    were taken for all participants in both groups (A&B) through asked all patients all questions in the questionnaire by: were you have symptoms such as: tension, anger, anxiety, depression and crying

    Full Information

    First Posted
    April 10, 2020
    Last Updated
    April 15, 2020
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04348201
    Brief Title
    Foot Reflexology on Premenstrual Syndrome
    Official Title
    Foot Reflexology Combined With Dietary Modification on Premenstrual Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    June 24, 2010 (Actual)
    Primary Completion Date
    January 30, 2020 (Actual)
    Study Completion Date
    January 30, 2020 (Actual)

    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
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    : Premenstrual Syndrome (PMS) is a set of physical, emotional and behavioral symptom that start during the week preceding menstruation and are alleviated when the menstrual flow begins. Reflexology is one of the most popular complementary therapies
    Detailed Description
    This study was aimed to determine the effect of foot reflexology in the treatment of premenstrual syndrome. Subjects and methods: Fifty volunteer, single females with premenstrual syndrome (PMS) were selected randomly from outpatient clinic of obstetrics and gynecology at Kasr El Ainy University Hospital, Faculty of Medicine, Cairo University to share in this study, their age ranged from 18 to 25 years old and their body mass index (BMI) did not exceed 30kg/m2, the participants were assigned into two groups of equal numbers. The group (A) received therapeutic foot reflexology with dietary modification 3 times/week for8 weeks, while the group (B) received dietary modifications only for 8 weeks. All subjects in both groups were assessed through the visual analogue scale (VAS) for pain and Premenstrual Daily Symptoms Questionnaire for (PMS) related symptoms. Results: The results of the present study revealed that there was statistically significant improvement in both pain and premenstrual related symptoms in group (A) than in group (B).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Reflexology, Dietary Modification

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Fifty volunteer, single females with premenstrual syndrome (PMS) were selected randomly from outpatient clinic of obstetrics and gynecology at Kasr El Ainy University Hospital, Faculty of Medicine, Cairo University to share in this study, their age ranged from 18 to 25 years old and their body mass index (BMI) did not exceed 30kg/m2, the participants were assigned into two groups of equal numbers. The group (A) received therapeutic foot reflexology with dietary modification 3 times/week for8 weeks, while the group (B) received dietary modifications only for 8 weeks
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    foot reflexology
    Arm Type
    Active Comparator
    Arm Description
    foot reflexology session which takes about 20 minutes.
    Arm Title
    dietary modification
    Arm Type
    Active Comparator
    Arm Description
    diet must be rich in vitamins.
    Intervention Type
    Other
    Intervention Name(s)
    foot reflexology
    Intervention Description
    foot reflexology session which takes about 20 minutes. The position of the patient during reflexology session was a relaxed comfortable supine lying position. The therapist was sitting position at the level of the feet. The Session of reflexology was done on three points at both feet.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    dietary modification
    Intervention Description
    diet must be rich in vitamins as fish and beans, calcium as milk and chess, low fat food through decrease oil in meals, high fiber food through all types of vegetables and fruits and restrict caffeine
    Primary Outcome Measure Information:
    Title
    Visual analogue scale
    Description
    was used to measure the severity of pain for each female in both groups (A, B) before and after the treatment according to 5 cm calibrated line with 0 (zero) representing no pain and 5 representing worst pain, each female in both groups (A&B) would be asked to mark on the line that represents her level of pain before and after treatment.
    Time Frame
    8 weeks
    Secondary Outcome Measure Information:
    Title
    Premenstrual daily symptoms questionnaire
    Description
    were taken for all participants in both groups (A&B) through asked all patients all questions in the questionnaire by: were you have symptoms such as: tension, anger, anxiety, depression and crying
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: their age ranged from 18 to 25 years old their body mass index (BMI) did not exceed 30kg/m2 Exclusion Criteria: Rheumatoid arthritis Bronchial asthma depression anxiety

    12. IPD Sharing Statement

    Learn more about this trial

    Foot Reflexology on Premenstrual Syndrome

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