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Effects of HIA and PCE in Primary Dysmenorrhea

Primary Purpose

Primary Dysmenorrhea

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
High intensity aerobics
Pelvic clock exercises
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Dysmenorrhea focused on measuring high intensity aerobics, primary dysmenorrhea, aerobics, painful menstruation

Eligibility Criteria

17 Years - 24 Years (Child, Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Girls aged 17-23 years with regular menstrual cycle
  • Unmarried girls

Exclusion Criteria:

  • Athletes, Married women,
  • Girls who were regularly exercising
  • Having any pelvic pathology, abnormal menstrual cycle.

Sites / Locations

  • Rasheeda gynae hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

high intensity aerobics

pelvic clock exercises

Arm Description

"London bridges (8mins)","Jumping lunges(8mins)","Mountain climbers(8mins)","Quadruped bent knee hip extension (8mins)"

Lie with your back on the floor in a neutral position with your legs bent and toes facing forward. Subject begin with gentle movements from 12 to 6 o'clock, as instructed to move from 3 o'clock to 9 o'clock. Then move in a clockwise manner from 12 to 3 to 6 to 9 and then back to 12 o' clock.

Outcomes

Primary Outcome Measures

Visual analogue scale
Scores are recorded by making a mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."

Secondary Outcome Measures

DASS 21
DASS-21 scale contains 7 items, divided into subscales with similar content.

Full Information

First Posted
February 20, 2022
Last Updated
February 25, 2022
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05258253
Brief Title
Effects of HIA and PCE in Primary Dysmenorrhea
Official Title
Effects of High Intensity Aerobics and Pelvic Clock Exercises in Primary Dysmenorrhea
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
February 8, 2021 (Actual)
Primary Completion Date
July 13, 2021 (Actual)
Study Completion Date
November 13, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The main purpose of study is to manage the unpleasant pain suffered by females during Mensturation. The aim of this study is to guide physiotherapist that how to apply these exercises to manage dysmenorrhea.
Detailed Description
There are less research on effectiveness of pelvic clock exercises in dysmenorrhea they are very less evidence and less documented in literature.. Although there are many researches on high intensity aerobics.Previous researches only have lierature about aerobics.So to address this literature gap, conduct a prospective randomized controlled trial to investigate the effects of high intensity aerobics and pelvic clock exercises in primary dysmenorrhea.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Dysmenorrhea
Keywords
high intensity aerobics, primary dysmenorrhea, aerobics, painful menstruation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
high intensity aerobics
Arm Type
Experimental
Arm Description
"London bridges (8mins)","Jumping lunges(8mins)","Mountain climbers(8mins)","Quadruped bent knee hip extension (8mins)"
Arm Title
pelvic clock exercises
Arm Type
Active Comparator
Arm Description
Lie with your back on the floor in a neutral position with your legs bent and toes facing forward. Subject begin with gentle movements from 12 to 6 o'clock, as instructed to move from 3 o'clock to 9 o'clock. Then move in a clockwise manner from 12 to 3 to 6 to 9 and then back to 12 o' clock.
Intervention Type
Other
Intervention Name(s)
High intensity aerobics
Intervention Description
"London bridges (8mins)" "Jumping lunges(8mins)" "Mountain climbers(8mins)" "Quadruped bent knee hip extension (8mins)"
Intervention Type
Other
Intervention Name(s)
Pelvic clock exercises
Intervention Description
Lie with your back on the floor in a neutral position with your legs bent and toes facing forward. Subject begin with gentle movements from 12 to 6 o'clock, as instructed to move from 3 o'clock to 9 o'clock. Then move in a clockwise manner from 12 to 3 to 6 to 9 and then back to 12 o' clock.
Primary Outcome Measure Information:
Title
Visual analogue scale
Description
Scores are recorded by making a mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."
Time Frame
last 1 day
Secondary Outcome Measure Information:
Title
DASS 21
Description
DASS-21 scale contains 7 items, divided into subscales with similar content.
Time Frame
last 1 day

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
only females
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Girls aged 17-23 years with regular menstrual cycle Unmarried girls Exclusion Criteria: Athletes, Married women, Girls who were regularly exercising Having any pelvic pathology, abnormal menstrual cycle.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara Aabroo, PPDPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rasheeda gynae hospital
City
Hafizabad
State/Province
Punjab
ZIP/Postal Code
140111
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effects of HIA and PCE in Primary Dysmenorrhea

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