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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04348201
Other study ID # Cairo Un 89
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 24, 2010
Est. completion date January 30, 2020

Study information

Verified date April 2020
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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).


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date January 30, 2020
Est. primary completion date January 30, 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 50 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
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