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Stretching Exercises on Symptoms of Primary Dysmenorrhea

Primary Purpose

Primary Dysmenorrhea

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
supervised stretching exercises
non-supervised active stretching home program
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Dysmenorrhea

Eligibility Criteria

18 Years - 23 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Zizi Mohammed Ibrahim Ali

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

supervised stretching exercises :group A

non-supervised active stretching home program: group B

Standard of care: group c

Arm Description

The intervention group A practiced a 30 to 45-minute supervised active stretching program three times a week for four weeks

practiced non-supervised active stretching home program

control group

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Full Information

First Posted
July 12, 2020
Last Updated
July 14, 2020
Sponsor
Cairo University
Collaborators
Princess Nourah Bint Abdulrahman University
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1. Study Identification

Unique Protocol Identification Number
NCT04475874
Brief Title
Stretching Exercises on Symptoms of Primary Dysmenorrhea
Official Title
Efficacy of Active Stretching Exercises on Symptoms of Primary Dysmenorrhea
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
February 10, 2019 (Actual)
Primary Completion Date
January 12, 2020 (Actual)
Study Completion Date
February 12, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
Collaborators
Princess Nourah Bint Abdulrahman 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
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.
Detailed 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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Dysmenorrhea

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
supervised stretching exercises :group A
Arm Type
Active Comparator
Arm Description
The intervention group A practiced a 30 to 45-minute supervised active stretching program three times a week for four weeks
Arm Title
non-supervised active stretching home program: group B
Arm Type
Active Comparator
Arm Description
practiced non-supervised active stretching home program
Arm Title
Standard of care: group c
Arm Type
No Intervention
Arm Description
control group
Intervention Type
Other
Intervention Name(s)
supervised stretching exercises
Other Intervention Name(s)
home program stretching exercises
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
non-supervised active stretching home program
Other Intervention Name(s)
home program of stretching exercises
Intervention Description
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
Primary Outcome Measure Information:
Title
Visual Analog Scale (VAS)
Description
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)
Time Frame
Change from Baseline at pain intensity 4 weeks after
Secondary Outcome Measure Information:
Title
Verbal Multidimensional System(VMS)
Description
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
Time Frame
Change from Baseline amenstruation characteristics 4 weeks after

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
23 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Zizi Mohammed Ibrahim Ali
City
Riyadh
State/Province
Nnjkjk
ZIP/Postal Code
2136
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Stretching Exercises on Symptoms of Primary Dysmenorrhea

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