Aim: Evaluating the effect of acupressure in the third liver, four large intestine and placebo points on the PMS symptoms and quality of life in girls with PMS
Design of study: randomized, one blinded
Population of study: Kowsar dormitory of Hormozgan University of Medical Sciences.
Inclusion criteria: Age of 18-45; passing at least two hours after the last meal; having moderate to severe PMS according to the score of premenstrual symptoms screening tool
Exclusion criteria: Infectious or skin diseases; acute rheumatoid arthritis; lesion or dermatitis at the site of applying pressure; visual or auditory impairment; avoid taking analgesics for three hours before starting the intervention; severe psychological tension during the last six months (loss of relatives, surgery, etc); heart disease, renal disorder, diabetes, asthma, hypothyroidism or hyperthyroidism, respiratory disorder; genital disease; interval between menstruation lower than 21 or upper than 35 days; PMS in all menstrual cycle
Sample size:90
Intervention: Acupressure in the third liver, four large intestine and placebo points
Intervention time: Twenty minutes acupressure during 14 days before menstruation for three consecutive menstrual cycles
Primary outcome: PMS severity, quality of life
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016060828038N2
Registration date:2016-06-14, 1395/03/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-06-14, 1395/03/25
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
2015-03-20, 1393/12/29
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of acupressure on quality of life in girls with PMS
Public title
Acupressure and premenstrual syndrome (PMS)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age of 18-45; passing at least two hours after the last meal; having moderate to severe PMS according to the score of premenstrual symptoms screening tool
Exclusion criteria: Infectious or skin diseases; acute rheumatoid arthritis; lesion or dermatitis at the site of applying pressure; visual or auditory impairment; avoid taking analgesics for three hours before starting the intervention; severe psychological tension during the last six months (loss of relatives, surgery, etc); heart disease, renal disorder, diabetes, asthma, hypothyroidism or hyperthyroidism, respiratory disorder; genital disease; interval between menstruation lower than 21 or upper than 35 days; PMS in all menstrual cycle
Age
From 18 years old to 45 years old
Gender
Male
Phase
2
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
Method of one blind was as that the subjects were not aware of their allocation to study groups.
Randomization was done with random numbers table.
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hormozgan University of Medical Sciences
Street address
Vice chancellor of research, Shahid Mohamadi Hospital, Bandarabbas, Hormozgan
City
Bandarabbas
Postal code
Approval date
2016-03-14, 1394/12/24
Ethics committee reference number
hums.rec.ac.164
Health conditions studied
1
Description of health condition studied
Premenstrual syndome
ICD-10 code
N94.3
ICD-10 code description
Premenstrual tension syndrome
Primary outcomes
1
Description
PMS severity
Timepoint
Start of mensuration in two cycles
Method of measurement
Premenstrual symptoms screening tool
Secondary outcomes
1
Description
Quality of life
Timepoint
Start of menstruation in two cycles
Method of measurement
SF-12 quality of life questionnaire
Intervention groups
1
Description
First intervention: Acupressure done in the third hepatic point that located at dorsal surface of the foot between the first and second toes at the point of bones junction.
Category
Other
2
Description
Second intervention: Acupressure done in the large intestine point that located at the dorsal surface of the hand between thumb and index finger approximately at the middle of the second metacarpus bone.
Category
Other
3
Description
Third intervention: Acupressure done in the placebo point that located at dorsal surface of the foot between the third and the forth toes which is not in the line of meridian.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Kowsar dormotory of Hormozgan University of Medical Sciences
Full name of responsible person
Mrs Salari
Street address
Kowsar dormotory, south Resalat street, Bandarabbas, Hormozgan
City
Bandarabbas
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor of research of Hormozgan University of Medical Science
Full name of responsible person
Abdolazim Nejatizadeh
Street address
Vice chancellor of research, Shahid Mohamadi Hospital, Bandarabbas, Hormozgan
City
Bandarabbas
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor of research of 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 Sciences
Full name of responsible person
Fatemeh Bazarganipour
Position
Assistant professor
Other areas of specialty/work
Street address
Nursing and midwifey University, south Resalat street, Bandarabbas, Hormozgan