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Comparison the effect of acupressure on third liver Point (liv.3) and sixth spleen point (SP.6) on pain intensity for patients with primary dysmenorrhea

Protocol summary

Summary
This study is performed for comparison the effect of acupressure on third liver, sixth spleen and placebo points on primary dysmenorrhea at female dormitory. One hundred and five people will be studied in three cycles. V.A.S. (visual analog scale) tool will be used to assess the pain intensity and those who take four points or more will participate in research. Then the subjects will be divided into three groups randomly: pressure on SP.6, liv.3 and placebo point. In the first menstrual cycle, participants will determine pain intensity at the onset of bleeding and half, 1, 2 and 3 hours later and we will teach them method of applying pressure. The pressure will be applied on both feet alternately as 2 minutes on the pressure point rotating clockwise and 2 minutes rest. Pressure will be applied two times on each leg and a total of four times (a total of 16 minutes). Each time pressure will be stopped with feeling De Chi (i.e. Feeling of tingling, heat, cold, creep) and will be applied on another foot after 2 minutes. In the second and third menstrual cycles, the research unit will apply the pressure herself. Pain intensity will record 0, 0.5, 1, 2, 3 hours after onset of bleeding using V.A.S. scale.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201201308869N1
Registration date: 2013-05-13, 1392/02/23
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-05-13, 1392/02/23
Registrant information
Name
Mahboobeh Kafaei Atrian
Name of organization / entity
Kashan University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1555 0021
Email address
kafaei_m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Sciences
Expected recruitment start date
2012-05-09, 1391/02/20
Expected recruitment end date
2013-02-18, 1391/11/30
Actual recruitment start date
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Actual recruitment end date
empty
Trial completion date
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Scientific title
Comparison the effect of acupressure on third liver Point (liv.3) and sixth spleen point (SP.6) on pain intensity for patients with primary dysmenorrhea
Public title
Effect of acupressure on dysmenorrhea
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Being a student at the dormitory, being single, regularity of menses, start of Pain with the onset of menstrual bleeding, duration of bleeding between 3-8 days and Menstrual intervals of 21-35 days, pain with a score of at least 4 of 10 according to the V.A.S. criteria in most menstrual cycles, lack of pain throughout the all times of menstrual cycle or bleeding, lack of anemia, high blood pressure, Psychiatric disorders especially depression (19 points or more, according to the beck-21 criteria for depression), lack of any known disease of genital tract, secondary dysmenorrhea, no history of abdominal or pelvic surgery, not using tobacco (cigarettes, hookah and drugs) and alcohol, disorders of speech and hearing, mental, heart and renal disorders, respiratory disease, diabetes, asthma, hypothyroidism or hyperthyroidism, severe psychological stress in the past 6 months (e.g., family death, surgery, marriage, separation of parents), lack of voluntary weight loss, absence of any problems in the pressure point such as fractures, ulcers, varicose veins, skin disease or inflammation, specific dietary regimen such as vegetarianism, eating raw, high salt or carbohydrates intake. Exclusion criteria: Use of heat, oral contraceptives or drugs that can affect on ovulation cycle, non steroidal anti-inflammatory, analgesic, Prostaglandins synthesis inhibitors for 4 hours before till 4 hours after applying pressure, not continue to cooperate until the end of the study (3 cycles).
Age
From 17 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 105
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
In this study, the research unit is not aware of effectiveness or ineffectiveness of pressure point. Also data analyzer is not aware of intervention and control groups. According to pain scale, blocking randomized allocation will be used to divide the sample study into intervention and control groups.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Kashan University of Medical Science
Street address
5th of Qotb-e Ravandi Blvd., Kashan University of Medical Science
City
Kashan
Postal code
8715981151
Approval date
2012-01-18, 1390/10/28
Ethics committee reference number
3613/1/5/29/پ

Health conditions studied

1

Description of health condition studied
Primary dysmenorrhoea
ICD-10 code
N-94.4
ICD-10 code description
Primary dysmenorrhoea

Primary outcomes

1

Description
Pain intensity
Timepoint
Pain intensity in the first cycle at the onset of bleeding and half, one, two and three hours after the onset of bleeding. Pain intensity in the second cycle at the onset of bleeding and half, one, two and three hours after the onset of bleeding. Pain intensity in the third cycle at the onset of bleeding and half, one, two and three hours after the onset of bleeding.
Method of measurement
Visual analog scale of pain intensity

Secondary outcomes

1

Description
Quality of life
Timepoint
Before intervention (first cycle) and after intervention (third cycle)
Method of measurement
Quality of life questionnaire (WHOQOL-BREF-26)

Intervention groups

1

Description
Pressure on sp.6 acupressure point. The pressure is applied on both feet alternately as 2 minutes in the pressure point rotating clockwise and 2 minutes rest. Pressure will be applied two times on each leg and a total of four times (a total of 16 minutes). Each time pressure will be stopped with feeling De Chi (i.e. Feeling of tingling, heat, cold, creep) and will be applied on another foot after 2 minutes
Category
Other

2

Description
Pressure on Liv.3 acupressure point. The pressure is applied on both feet alternately as 2 minutes in the pressure point rotating clockwise and 2 minutes rest. Pressure will be applied two times on each leg and a total of four times (a total of 16 minutes). Each time pressure will be stopped with feeling De Chi (i.e. Feeling of tingling, heat, cold, creep) and will be applied on another foot after 2 minutes.
Category
Other

3

Description
Pressure on placebo point. The pressure is applied on both feet alternately as 2 minutes in the pressure point rotating clockwise and 2 minutes rest. Pressure will be applied two times on each leg and a total of four times (a total of 16 minutes). Each time pressure will be stopped with feeling De Chi (i.e. Feeling of tingling, heat, cold, creep) and will be applied on another foot after 2 minutes.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Female Dormitories of Kashan University of Medical Sciences
Full name of responsible person
Tahereh Mazoochi, Ph.D. in Histology, associate professor
Street address
Five kilometers of Ghotbe Ravandi Blvd., Female Dormitories of Kashan University of Medical Sciences
City
Kashan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Kashan University of Medical Sciences
Full name of responsible person
Gholamali Hamidi
Street address
5th km of Qotbe Ravandi Blvd., Kashan University of Medical Sciences
City
Kashan
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, Kashan University of Medical Sciences
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
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Person responsible for general inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mahboobeh Kafaei Atrian
Position
MSc. Faculty member
Other areas of specialty/work
Street address
5th km of Ghotbe Ravandi Blvd., Kashan University of Medical Sciences
City
Kashan
Postal code
Phone
+98 36 1555 0021
Fax
Email
kafaei_m@kaums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Science
Full name of responsible person
Mahboobeh Kafaei Atrian
Position
MSc. Faculty member
Other areas of specialty/work
Street address
5th km of Ghotbe Ravandi Blvd., Kashan University of Medical Sciences
City
Kashan
Postal code
8715981151
Phone
+98 36 1555 0021
Fax
Email
kafaei_m@kaums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mahboobeh Kafaei Atrian
Position
MSc.- Faculty member
Other areas of specialty/work
Street address
5th km of Ghotbe Ravandi Blvd., Kashan University of Medical Sciences
City
Kashan
Postal code
8715988141
Phone
+98 36 1555 0021
Fax
+98 36 1555 6633
Email
kafaei_m@kaums.ac.ir
Web page address

Sharing plan

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