The aim of this study was to evaluate acupressure effect on severity and duration of pain. A total of 200 students aged 18-21 year, educated at Nasibe Tarbiat Moalem College, single, have regular menstruation, and have pain scoring 4-10 on Wong-baker faces pain rating score were recruited. The intervention was acupressure on liv3 point or placebo and primary outcome were severity and duration of primary dysmenorrhea and symptom of liver channel evaluated for four menstrual cycle.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138808272731N1
Registration date:2010-02-16, 1388/11/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-02-16, 1388/11/27
Registrant information
Name
Fatemeh Bazarganipour
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 21 8822 0209
Email address
bazarganipour@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Tarbiat Modares University
Expected recruitment start date
2008-10-22, 1387/08/01
Expected recruitment end date
2009-03-19, 1387/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The evaluation of effect of acupressure on primary dysmenorrheal
Public title
The evaluation of effect of acupressure on primary dysmenorrheal
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age 18-21 years, having regular menstrual cycles (duration of 3-8 days and interval of 21-35 days). presence of moderate to severe pain i.e. a score of 4 or more on a wrong-Baker faces pain scale, presence of symptoms of liver channel, presence of fix or sharp pain in lower abdomen for 1-2 day prior to onset of menstruation, distension feel in abdomen and breast, presence of dark-colored menstruation with clotting, irritability or depression and sometimes sleeplessness prior to onset of menstruation, tongue with red-colored seed, worsening the pain with pressure on abdominal), no prior history of gynecological disease or abdominal or pelvic surgery, no pain during menstrual cycle or menstruation duration, 2 hours after meal
Exclusion criteria: history of mental stress in last 6 month especially having moderate to severe level of depression (score of 19 or more in beck-21 inventory), taking analgesics during 4 hours before intervention, menstruation cycle lower than 25 days or more than 35 days, use of tobacco products, or alcohol, presence of verbal, audible, mental problems, heart disease, kidney disease, diabetes mellitus, asthma, hyperthyroid or hypothyroid, or respiratory disease, presence of scar or inflammatory disease in acupoint.
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:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Inclusion criteria: age 18-21 years, having regular menstrual cycles (duration of 3-8 days and interval of 21-35 days). presence of moderate to severe pain i.e. a score of 4 or more on a wrong-Baker faces pain scale, presence of symptoms of liver channel, presence of fix or sharp pain in lower abdomen for 1-2 day prior to onset of menstruation, distension feel in abdomen and breast, presence of dark-colored menstruation with clotting, irritability or depression and sometimes sleeplessness prior to onset of menstruation, tongue with red-colored seed, worsening the pain with pressure on abdominal), no prior history of gynecological disease or abdominal or pelvic surgery, no pain during menstrual cycle or menstruation duration, 2 hours after meal
Exclusion criteria: history of mental stress in last 6 month especially having moderate to severe level of depression (score of 19 or more in beck-21 inventory), taking analgesics during 4 hours before intervention, menstruation cycle lower than 25 days or more than 35 days, use of tobacco products, or alcohol, presence of verbal, audible, mental problems, heart disease, kidney disease, diabetes mellitus, asthma, hyperthyroid or hypothyroid, or respiratory disease, presence of scar or inflammatory disease in acupoint.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tarbiat Modares Unovercity
Street address
Tehran, Gisha bridge
City
Tehran
Postal code
1411713116
Approval date
empty
Ethics committee reference number
15064459
Health conditions studied
1
Description of health condition studied
primary dysmenorrhea
ICD-10 code
N94.4
ICD-10 code description
Pain and other conditions associated with female genital organs and menstrual cycle
Primary outcomes
1
Description
Liver channel symptoms
Timepoint
first and fourth cycles
Method of measurement
liver channel symptoms questionnare-interview to patient
2
Description
Severity of dysmenorrhea
Timepoint
first and fourth cycles
Method of measurement
multidimensional scoring system -interview with patient
3
Description
Pain severity
Timepoint
monthly
Method of measurement
wrong-Baker faces pain scale-interview to patient
4
Description
Pain duration
Timepoint
monthly
Method of measurement
questionnare-interview to patient
Secondary outcomes
empty
Intervention groups
1
Description
In the experiment group, acupressure done on liv3 point located two thumb-widths behind the skin-margin between the first (big) and second toes for 3-7 days before the onset of menstruation for 20 minutes and follow up for 4 menstruation cycles
Category
Other
2
Description
In the control group, acupressure done on placebo point located two thumb-widths behind the skin-margin between the first (big) and second toes for 3-7 days before the onset of menstruation for 20 minutes and follow up for 4 menstruation cycles
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Nasibe Tarbiat Moallem center
Full name of responsible person
Master and students in this center
Street address
Nasibe Ave., Marzdaran Blvd,Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tarbait Modares University
Full name of responsible person
Research Assisstant of university
Street address
Tehran, Gisha bridge
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?