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Comparison of acupressure effect of the third liver, fourth large intestine and placebo points on quality of life of girls with primary dysmenorrhea.

Protocol summary

Summary
Aim of study: evaluation of acupressure effect of the third liver, fourth large intestine and placebo points on quality of life of girls with primary dysmenorrhea. Study design: one blind randomized. Study population: this study is a randomized single blind controlled clinical trial undertaken with students with primary dysmenorrhea living in the Kowsar dormitory of the Hormozgan University of Medical Science, Iran from 2015-2016. Inclusion criteria: age between 18-21; being single; regular menstrual period ( duration of 3-8 days and the interval of 21-35 days); a pain score of 4-10 according to the Wong-Baker faces pain scale; no genital disease; at least two hours passing after the last meal; absence of pain in all days of menstrual bleeding; no usage of oral or other contraceptives or drugs which disturb the ovulation cycle (NSAIDS, analgesics, prostaglandin synthesis inhibitors) four days before acupressure is started; lack of any abdominal/pelvic surgery; absence of tobacco consumption; not being alcohol consumer; absence of any speaking, visual, and auditory problems; absence of medical disease(cardio-vascular disease, nephropathy, respiratory disorders, diabetes, asthma, hypo/hyper thyroidism; absence of any severe psychological stress during the last six months(loss of relatives, etc); absence of any lesion, varices, or inflammatory skin disease at the location of applying pressure. Exclusion criteria: no desire of participant to cooperative in the study. Study sample: 90 people (30 people per group). Intervention: 20 minutes acupressure on the third liver, fourth large intestine and placebo points for five days before of menstruation for two menstrual cycles. Time intervention: five days before of menstruation for two menstrual cycles for 20 minutes. Primary outcomes: pain severity, pain duration, quality of life.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016052428038N1
Registration date: 2016-07-04, 1395/04/14
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-07-04, 1395/04/14
Registrant information
Name
Fatemeh Bazarganipour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 76 3366 6367
Email address
bazarganipour@hums.ac.ir
Recruitment status
Recruitment complete
Funding source
Hormozgan University of Medical Sciences
Expected recruitment start date
2015-04-21, 1394/02/01
Expected recruitment end date
2017-03-20, 1395/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of acupressure effect of the third liver, fourth large intestine and placebo points on quality of life of girls with primary dysmenorrhea.
Public title
Effect of acupressure in dysmenorrhea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: female gender; age between 18-21 years old; being single; regular menstrual period ( duration of 3-8 days and the interval of 21-35 days); a pain score of 4-10 according to the Wong-Baker faces pain scale; no genital disease; at least two hours passing after the last meal; absence of pain in all days of menstrual bleeding; no usage of oral or other contraceptives or drugs which disturb the ovulation cycle (NSAIDS, Analgesics, Prostaglandin synthesis inhibitors) four days before acupressure is started; lack of any abdominal/pelvic surgery; absence of tobacco consumption; not being alcohol consumer; absence of any speaking, visual, and auditory problems; absence of medical disease(cardio-vascular disease, nephropathy, respiratory disorders, diabetes, asthma, hypo/hyper thyroidism; absence of any severe psychological stress during the last six months(loss of relatives, etc); absence of any lesion, varices, or inflammatory skin disease at the location of applying pressure. Exclusion criteria: no desire of participant to cooperative in the study.
Age
From 18 years old to 21 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Hormozgan University of Medical Science
Street address
Hormozgan University of Medical Science
City
Bandarabbas
Postal code
Approval date
2016-03-14, 1394/12/24
Ethics committee reference number
HUMS.REC.1394.165

Health conditions studied

1

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

Primary outcomes

1

Description
Pain severity
Timepoint
Start of mensturation for two mentrural cycles
Method of measurement
Questionnaire

Secondary outcomes

1

Description
Quality of life
Timepoint
start of mensturation for two mentrural cycles
Method of measurement
Questionnaire

Intervention groups

1

Description
LIV3 group: The LIV3 point (or third hepatic acupoint) is one of the hepatic meridians located at the point of bones junction. LI4 group: The LI4 point (HUGO) is located at the dorsal surface of the hand between the thumb and the index finger, at the middle of the second metacarpus bone. Placebo group:The placebo point is located between the third and the forth toes which is not in the meridian line
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
University Students Dormitory
Full name of responsible person
Street address
City
Bandarabbas

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hormozgan University of Medical Science
Full name of responsible person
Abdolazim Nejatizadeh
Street address
No. 7916839319, Vice chancellor for research, Shahid Mohammadi hospital, Bandarabbas
City
Bandarabbas
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hormozgan University of Medical Science
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
Hormozgan University of Medical Science
Full name of responsible person
Dr. Fatemeh Bazarganipour
Position
Faculty member
Other areas of specialty/work
Street address
No. 7916839319, South Resalat street, Bandarabbas, Hormozgan
City
Bandarabbas
Postal code
Phone
+98 76 3333 7192
Fax
Email
bazarganipour@hums.ac.ir; f.bazarganipour@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hormozgan University of Medical Science
Full name of responsible person
Dr. Fatemeh Bazarganipour
Position
Ph.D
Other areas of specialty/work
Street address
No. 7916839319, South Resalat street, Bandarabbas, Hormozgan
City
Bandarabbas
Postal code
Phone
+98 76 3333 7192
Fax
Email
bazarganipour@hums.ac.ir; f.bazarganipour@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Hormozgan University of Medical Science
Full name of responsible person
Fatemeh Bazarganipour
Position
Assistant professor
Other areas of specialty/work
Street address
No. 7916839319, South Resalat street, Bandarabbas, Hormozgan
City
Bandarabbas
Postal code
Phone
+98 76 3366 6367
Fax
Email
bazarganipour@hums.ac.ir; f.bazarganipour@gmail.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
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