NCT04348201

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2010

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 24, 2010

Completed
9.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 16, 2020

Completed
Last Updated

April 17, 2020

Status Verified

April 1, 2020

Enrollment Period

9.6 years

First QC Date

April 10, 2020

Last Update Submit

April 15, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Premenstrual daily symptoms questionnaire

    8 weeks

Study Arms (2)

foot reflexology

ACTIVE COMPARATOR

foot reflexology session which takes about 20 minutes.

Other: foot reflexology

dietary modification

ACTIVE COMPARATOR

diet must be rich in vitamins.

Dietary Supplement: dietary modification

Interventions

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.

foot reflexology
dietary modificationDIETARY_SUPPLEMENT

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

dietary modification

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Rheumatoid arthritis
  • Bronchial asthma
  • depression
  • anxiety

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Diet Therapy

Intervention Hierarchy (Ancestors)

Nutrition TherapyTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor Department of Physical Therapy for Women's Health, Faculty of Physical therapy, Cairo University, Egypt

Study Record Dates

First Submitted

April 10, 2020

First Posted

April 16, 2020

Study Start

June 24, 2010

Primary Completion

January 30, 2020

Study Completion

January 30, 2020

Last Updated

April 17, 2020

Record last verified: 2020-04