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
About this trial
This is an interventional treatment trial for Reflexology
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
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
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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