Foot Reflexology on Premenstrual Syndrome

Foot Reflexology Combined With Dietary Modification on Premenstrual Syndrome

: 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

Study Overview

• Status: Completed
• Conditions: Dietary Modification; Reflexology
• Intervention / Treatment: Other: foot reflexology; Dietary supplement: dietary modification

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).

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: foot reflexology; foot reflexology session which takes about 20 minutes.	Other: foot reflexology; 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.
ACTIVE_COMPARATOR: dietary modification; diet must be rich in vitamins.	Dietary supplement: dietary modification; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	8 weeks

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 24, 2010
• Primary Completion (ACTUAL): January 30, 2020
• Study Completion (ACTUAL): January 30, 2020

Study Registration Dates

• First Submitted: April 10, 2020
• First Submitted That Met QC Criteria: April 14, 2020
• First Posted (ACTUAL): April 16, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 17, 2020
• Last Update Submitted That Met QC Criteria: April 15, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Menstruation Disturbances; Premenstrual Syndrome
• Other Study ID Numbers: Cairo Un 89

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No