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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04475874
Other study ID # DPTPNU
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 10, 2019
Est. completion date February 12, 2020

Study information

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

Clinical Trial Summary

The purpose of this study was to assess the effect of active stretching exercises on reducing pain and the quality of life during menstrual cycle in young adult females.


Description:

Thirty females with primary dysmenorrhea, aging between 18 to 23 years with BMI of 20-29.9 kg/m2, have a regular menstrual cycle length 28-30 day and cycle bleed from 3 to 7 days, were randomly assigned into three equal groups; two interventions groups (supervised and non-supervised active stretching exercise program) and one control group. The intervention group A practiced a 30 to 45-minute supervised active stretching program three times a week for four weeks, while the other intervention group B practiced non-supervised active stretching home program and the control group C . Visual Analog Scale (VAS) was used to measure pain intensity, and Verbal Multidimensional System (VMS) for measuring menstruation characteristics and the effect of pain on quality of life, before (pre) as well as after (post) 4 weeks at the end of the study .


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date February 12, 2020
Est. primary completion date January 12, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 23 Years
Eligibility Inclusion Criteria:

- BMI of 20-29.9 kg/m2,

- regular menstrual cycle

- length 28-30 day

- cycle bleed from 3 to 7 days,

Exclusion Criteria:

- contraindication to stretching exercise

- taking any hormonal medications:

- smoker

Study Design


Related Conditions & MeSH terms


Intervention

Other:
supervised stretching exercises
30 to 45-minute supervised active stretching program by a trained physical therapist, three times a week for four weeks starting with a warmup of 5 minutes on a stationary bicycle, half jumping jacks and torso rotations
non-supervised active stretching home program
non supervised 30 to 45-minute supervised active stretching program three times a week for four weeks starting with a warmup of 5 minutes on a stationary bicycle, half jumping jacks and torso rotations

Locations

Country Name City State
Saudi Arabia Zizi Mohammed Ibrahim Ali Riyadh Nnjkjk

Sponsors (2)

Lead Sponsor Collaborator
Cairo University Princess Nourah Bint Abdulrahman University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Visual Analog Scale (VAS) Visual Analog Scale measures pain intensity it is a unidimensional measure of pain intensity The classification of VAS was done according to pain scores (mild: 1-3 Moderate: 4-7 Severe: 8-10) Change from Baseline at pain intensity 4 weeks after
Secondary Verbal Multidimensional System(VMS) Verbal Multidimensional System which is a grading system from zero to three and used to evaluate menstruation characteristics including the working ability, the systemic symptoms and analgesia requirement in order to decrease pain with dysmenorrhea Change from Baseline amenstruation characteristics 4 weeks after
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