Protocol summary

Summary
Objectives: The Study aimed to assess the effect of a Core Stability Exercises program on pain severity, pain duration and drug consumption in primary dysmenorrhea in adult female. Design: In this randomized controlled trial, participants were randomly assigned to an experimental group (17 subjects) and a control group (17 subjects). Setting and conduct: The subjects in exercise group participated in an 8 week (3 sessions a week) Core Stability Exercise program. But the control group didn’t participate in any intervention. Participants: young girls aged 18- 25 years old who lived in Arak and had these conditions: persistent primary dysmenorrhea of more than 6 months with regular menstruation cycles, no history of pregnancy, low back pain, polycystic ovary disease or pelvic infection. Intervention: Core Stability Exercise program was prescribed to the subjects in exercise group in 8 weeks (3 sessions a week). Main outcome measures: Numeric Pain Scale, the number of hours that the pain continued and total number of painkillers consumption for the pain reduction were used in pre and post-test for evaluation of pain intensity, pain duration, and drug usage.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016103119024N2
Registration date: 2016-11-13, 1395/08/23
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-11-13, 1395/08/23
Registrant information
Name
Fahime Mahmoudi
Name of organization / entity
Arak University
Country
Iran (Islamic Republic of)
Phone
+98 71 5383 0850
Email address
f-mahmoudi@arshad.araku.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Arak University
Expected recruitment start date
2013-04-20, 1392/01/31
Expected recruitment end date
2013-06-21, 1392/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of a core stability exercise program on the primary dysmenorrhea in young adult females- a randomized controlled trial
Public title
The effect of exercise on primary dysmenorrhea
Purpose
Treatment
Inclusion/Exclusion criteria
Major inclusion criteria: Young Adult Females 18- 25 years old who lived in Iran, Arak; persistent primary dysmenorrhea of more than 6 months with regular menstruation cycles; no history of pregnancy; low back pain; diabetes; poly cystic ovary disease; pelvic infection or pelvic pain with no relation to dysmenorrhea. Major exclusion criteria: tolerating inability to exercise; having any additional physical activity; taking any medications or vitamin and mineral supplements.
Age
From 18 years old to 25 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 34
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Arak University of Medical Sciences,Sardasht, Arak, Iran
City
Arak
Postal code
38156 - 879
Approval date
2013-11-11, 1392/08/20
Ethics committee reference number
92-154-12

Health conditions studied

1

Description of health condition studied
Primary dysmenorrhea
ICD-10 code
N94.4
ICD-10 code description
Primary dysmenorrhea

Primary outcomes

1

Description
Pain intensity
Timepoint
Pre and post test
Method of measurement
Numeric Pain Scale

2

Description
Pain duration
Timepoint
Pre and post test
Method of measurement
The number of hours that the pain continued

3

Description
Druge usage
Timepoint
Pre and post test
Method of measurement
Total number of painkillers consumption for the pain reduction

Secondary outcomes

empty

Intervention groups

1

Description
The subjects in exercise group participated in an 8 week (3 sessions a week) Core Stability Exercise program.
Category
Other

2

Description
The control group didn’t participate in any intervention.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Arak University
Full name of responsible person
Fahime Mahmoudi
Street address
Arak University, Shareaati street, Arak, Iran
City
Arak

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Arak University
Full name of responsible person
Doctor Alireza Fazlaali
Street address
Vice chancellor for research, Arak University, Oloum Alley, Shariati Square, Arak, Iran
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Arak University
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Arak University
Full name of responsible person
Fahime Mahmoudi
Position
M.Sc of Physical Training and Sport Sciences
Other areas of specialty/work
Street address
Arak University, Shareaati street, Arak, Iran
City
Arak
Postal code
38138-5-3945
Phone
+98 71 5383 0850
Fax
Email
Fahime.mahmoudi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University
Full name of responsible person
Fahime Mahmoudi
Position
M.Sc of Physical Training and Sport Sciences
Other areas of specialty/work
Street address
Arak University, Shareaati street, Arak, Iran
City
Arak
Postal code
38138-5-3945
Phone
+98 71 5383 0850
Fax
Email
Fahime.mahmoudi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Arak University
Full name of responsible person
Fahime Mahmoudi
Position
M.Sc of Physical Training and Sport Sciences
Other areas of specialty/work
Street address
Arak University, Shareaati street, Arak, Iran
City
Arak
Postal code
38138-5-3945
Phone
+98 71 5383 0850
Fax
Email
Fahime.mahmoudi@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...