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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04359381
Other study ID # 90
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 24, 2019
Est. completion date March 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

Sixty girls participated in this study and their main complaints were pain and cramping during menstruation. They were divided randomly into two equal groups.


Description:

Group (A) (30 girls) treated by kinesiotaping during menstruation for 3 successive menstruation. Group (B) (30 girls) treated by pilate exercises, 3 sessions per week for 3 months except the days of menstruation. Visual analogue scale to assess pain intensity, Quality of life enjoyment and satisfaction questionnaire, Menstrual Distress Questionnaire, WALIDD score, Spielberger questionnaire and blood sample analysis to estimate plasma prostaglandin level were applied for each girl in both groups before and after the treatment course.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date March 30, 2020
Est. primary completion date March 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 14 Years to 20 Years
Eligibility Inclusion Criteria:

- Their ages ranged from 14 to 20 years old

- their body mass index (BMI) would be less than 25 Kg/m2

- having primary dysmenorrhoea

Exclusion Criteria:

- skin diseases or cardiac diseases

- irregular or infrequent menstrual cycles

- previous abdominal or back operations

Study Design


Related Conditions & MeSH terms


Intervention

Other:
kinesiotaping application
kinesiotaping was applied once the menstrual pain begins (one day before menstruation) for periods of 4 to 5 days until the pain disappears and then removed it. Kinesiotaping was used for 3 successive menstruations.
Pilate exercises program
Each girl in group (B) was engaged in a supervised pilate exercises program for 30 minutes per session for 3 days/week for 12 weeks except days of menstruation. Participants would be oriented to wear comfortable clothes .

Locations

Country Name City State
Egypt Ghada Elrefaye Cairo

Sponsors (3)

Lead Sponsor Collaborator
Cairo University Amira Hassan Abdelaziz, Soheir Mahmoud El-Kosery

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Weight and height scale Was used to measure the weight and height of each girl before starting the study and to calculate BMI according to the following formula: BMI = weight (kg) / height square (m)2 three months
Secondary Visual analog scale For determining pain intensity before and after the treatment course for each girl in both groups (A&B). VAS is a-10 cms line, at one end was written (no pain = zero) and at the other end was written (worst pain the patient ever felt = 10) three months
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