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Effect of pressure on tenth spleen point on pain intensity and amount of bleeding in primary dysmenorrhea

Protocol summary

Summary
Objective:The aim of this study is investigating effect of acupressure on pain severity and amount of bleeding on primery dysmenorrhea Design: This is a semi experimental single blind study which conducted on 100 female residents of Tehran university dormitories suffering from primary dysmenorrhea. Setting and conduct: At First, two of Tehran university dormitories is selected randomly via computerized randomization program as control and intervention groups, then purposive sampling is done. Participants: Participants are all of the female residents of Tehran dormitories whom are eligible for inclusion criteria. Inclusion criteria: aged 18 to 30, single , having regular menstrual period, without any pelvic disease or genital system anomalies. Exclusion criteria: using of oral contraceptive drugs or medications intervene with ovulation cycle, Having sever anxiety and stress during the survey. Research instruments are demographic questionnaire, VAS, and visibility scale Cample and Monoga. One month before the intervention, research instruments are tested in both groups. Intervention: There is no intervention in control group, but just there is usual care. in intervention group, finding tenth spleen point and, how to do pressure is taught in an hour with demonstrating the technique. Then this pressure is done for 4 cycles by samples. Main outcome and major variables: Pain intensity and amount of bleeding is recorded in the period of intervention in both groups. Then all of statics data are analyzed.

General information

Acronym
-
IRCT registration information
IRCT registration number: IRCT201211203037N6
Registration date: 2014-09-14, 1393/06/23
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-09-14, 1393/06/23
Registrant information
Name
Mehrnaz Geranmayeh
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6694 1669
Email address
geranmay@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical Sciences
Expected recruitment start date
2013-01-14, 1391/10/25
Expected recruitment end date
2013-08-22, 1392/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of pressure on tenth spleen point on pain intensity and amount of bleeding in primary dysmenorrhea
Public title
Effect of pressure on tenth spleen point on pain intensity and amount of bleeding in primary dysmenorrhea
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: age 18 to 30 years; menstrual pain intensity based on visual pain scale is grade 1, 2 or 3; unmarried; Having regular menstrual periods (Duration of 3 to 8 days, and the interval between two menstrual periods from 21 to 35 days); Absence of psychological disorders especially depression, moderate and severe (earn points 19 and greater according to Beck Depression Inventory); absence of pain during all cycle or during the time of menstrual bleeding; There is no history of abdominal-pelvic surgery; without any pelvic disease And genital system anomalies; absence of ulceration, varices and inflammatory disease or skin in the area of tenth of splenic. Exclusion criteria: using of oral contraceptive drugs, medications which interfere with ovulation or prostaglandin synthesis inhibitors during the study; any extreme psychological stress during the study.
Age
From 18 years old to 30 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
by making on accident is computer Among Tehran university dormitories just two of them were selected as a Control group and another intervention group

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethical committee of Tehran University of Medical Sciences
Street address
Central Building of Tehran University of Medical Sciences, Ghods street, Keshavarz boulevard, Tehran
City
Tehran
Postal code
-
Approval date
2013-01-27, 1391/11/08
Ethics committee reference number
2765/130/د/91

Health conditions studied

1

Description of health condition studied
dysmenorrhea
ICD-10 code
F45.8
ICD-10 code description
Other somatoform disorders

Primary outcomes

1

Description
Pain intensity in primary dysmenorrhea
Timepoint
Before intervention and 1, 2, 3, 4 Months after intervention
Method of measurement
Pain ruler

2

Description
Amount of bleeding in primary dysmenorrhea
Timepoint
Before intervention and 1, 2, 3, 4 Months after intervention
Method of measurement
Campbell and Mvnga Visual Chart

Secondary outcomes

1

Description
-
Timepoint
-
Method of measurement
-

Intervention groups

1

Description
intervention group: in this group during a 30 minute meeting find tenth spleen point and how to do pressure is taught and and technique done. Then this survey is done for 4 cycles by a person who has trained. Pain intensity and amount of bleeding is recorded in this period of time after finishing technique.
Category
Treatment - Other

2

Description
Control group: There is no intervention in control group, but just there is usual care.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Dormitory of Tehran University of Medical Sciences (kooye daneshgah dormitory)
Full name of responsible person
Hamideh Izadi,MS. student of midwifery
Street address
Kooy-e- daneshgah dormitory, North Karegar Ave.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical sciences
Full name of responsible person
Doctor Masoud Younesian
Street address
Central Building of Tehran University of Medical Sciences, Ghods street, Keshavarz boulevard, Tehran
City
Tehran
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, Tehran 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
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hamideh, Izadi
Position
Student of master of Sciences in midwifery
Other areas of specialty/work
Street address
Tehran University of Medical Science, school of nursing and midwifery, East Nusrat Street, Tohid Square, Tehran
City
Tehran
Postal code
-
Phone
+98 21 6105 4226
Fax
-
Email
ezadi.hamide@yahoo.com
Web page address
-

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hamideh Izadi
Position
Student of master of sciences in midwifery
Other areas of specialty/work
Street address
Tehran University of Medical Science, School of Nursing and Midwifery, East Nusrat Street, Tohid Square, Tehran
City
Tehran
Postal code
-
Phone
+98 21 6105 4226
Fax
-
Email
ezadi.hamide@yahoo.com
Web page address
www.tums.ac.ir/research

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hamideh Izadi
Position
Student of Master of Sciences in midwifery
Other areas of specialty/work
Street address
Tehran University of Medical Science, school of nursing and midwifery, East Nusrat Street, Tohid Square, Tehran
City
Tehran
Postal code
-
Phone
+98 21 6105 4226
Fax
-
Email
ezadi.hamide@yahoo.com
Web page address
www.tums.ac.ir/research

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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