Comparison of the effect of acupressure and fluoxetine on physical and psychological symptoms of premenstrual syndrome
Design
Randomized controlled clinical trial, with parallel group
Settings and conduct
Research population: All female students of Islamic Azad University of Qazvin who have entered the study.For the first diagnosis of syndrome from set temporary premenstrual syndrome used.Beck Depression Inventory is provided to affected people, and depressed people are excluded from the study based on the score.Then, for the definitive diagnosis, the selected individuals are asked to complete the DRSP for 2 cycles. Subjects were then randomly divided into two groups of intervention (acupressure and fluoxetine) and control group.The acupressure group receives acupressure for 18 consecutive sessions in three cycles. And the fluoxetine group received 10 mg of fluoxetine in the luteal phase every 12 hours in three successive cycles. The subjects are asked to complete the DRSP during the intervention and again three months after the end of the intervention.
Participants/Inclusion and exclusion criteria
Entry requirements: Regular menstruation, normalization of bleeding length and volume, range from 18 to 35 years
Having normal body mass, having symptoms of premenstrual syndrome in two cycles before intervention
Intervention groups
Acupressure group: Acupressure is given by using aTENS machine for 15 minutes in the second half of the menstrual cycle for 12 days in a one-day interval, namely 6 sessions in three consecutive cycles.
Fluoxetine group: In the luteal phase, fluoxetine capsules receive 10 mg every 12 hours
Control group: There is no intervention and only they will be asked to complete the sixth month of the DRSP questionnaire every month until the third month and again.
Main outcome variables
Physical and psychosomatic symptoms of premenstrual syndrome
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190430043433N1
Registration date:2019-05-11, 1398/02/21
Registration timing:prospective
Last update:2019-05-11, 1398/02/21
Update count:1
Registration date
2019-05-11, 1398/02/21
Registrant information
Name
Zeinab Zarabadipour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3335 3695
Email address
z.zarabadipour@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-22, 1398/03/01
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare the effect of acupressure therapy and Fluoxetine on the symptoms of premenstrual syndrome: A randomized clinical trial
Public title
Acupressure therapy in premenstrual syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The desire to participate in the study
Regular menstruation from 24 to 35 days
The normalization of the length and volume of menstrual bleeding is 3-10 days
Age range 18 to 35 years
Having a Body Mass (25 -5/18)
. Having symptoms of premenstrual syndrome in two cycles before starting the intervention
Non-Depression Based on the Beck Questionnaire
Having a phone number to follow
Exclusion criteria:
Having known psychological illnesses (according to the person)
Use of any drug for the treatment of premenstrual syndrome
Tobacco use, narcotics and psychotropic drugs (according to the person)
Having regular exercise
Use of antidepressants, sedation and hormones and vitamin supplements
There are skin lesions in acupressure points
A stressful incident in the past six months, such as: separation of parents, death of first-degree family members, and ....
Use of any drug that has fluoxetine interactions
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling takes place in two stages: the first stage, the selection of eligible samples is available and the second stage of random allocation will be divided into three groups by blocking method.
For placement of the samples in three groups (two intervention and one control group) using the PSSA software, a randomly blocked block size of 6, 12 and 12 with a 1: 1: 1 ratio is used
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Qazvin University of Medical Sciences
Street address
Dept of research Qazvin University of Medical Sciences Shahid Beheshti, Ave' 3415613911 Qazvin' IRAN
City
Qazvin
Province
Qazvin
Postal code
13911/34156
Approval date
2019-04-29, 1398/02/09
Ethics committee reference number
IR.QUMS.REC.1398.014
Health conditions studied
1
Description of health condition studied
Premenstural syndrome
ICD-10 code
N94.3
ICD-10 code description
Premenstrual tension syndrome
Primary outcomes
1
Description
Physical symptoms of premenstrual syndrome
Timepoint
Two months before the intervention, during the intervention, three months after the end of the intervention
Method of measurement
Daily Record of Severity of Problems chart
2
Description
Psychosomatic symptoms of premenstrual syndrome
Timepoint
Two months before the intervention, during the intervention, three months after the end of the intervention
Method of measurement
Daily Record of Severity of Problems chart
Secondary outcomes
empty
Intervention groups
1
Description
IThe first intervention group: received acupressure completely free of charge for 15 minutes in the second half of the menstrual cycle for 12 days in a one day interval, namely 6 sessions in three consecutive cycles. Acupressure by a researcher at points LIV3, SP9, LI 11, LI 4 is performed using a TENS with a pulse width of 4-200 Hz. Each session will be used as one side of the limb of one side (left or right)
Category
Treatment - Other
2
Description
he second intervention group: the fluoxetine group. Firstly, the necessary training will be given to fluoxetine and the possible side effects of the onset of the drug, and in the event of a problem, the physician will be provided with the samples. Samples are taken for three consecutive cycles every 12 hours under the supervision of a specialist physician to reduce the complications in the luteal phase. 10 mg of fluoxetine capsule (Sobhan Pharmaceutical Company)
Category
Treatment - Drugs
3
Description
Control group: There is no intervention and only they will be asked to complete the sixth month of the DRSP questionnaire every month until the third month and again. Calling will be made every month to remind the samples. To follow ethical principles after the completion of the research, a training session on the treatment of premenstrual syndrome and an acupressure session will be conducted in accordance with the study protocol for applicants.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Islamic Azad University of Qazvin
Full name of responsible person
Zeinab zarabadipour
Street address
Bahonar Blvd. Qazvin University of Medical Sciences
City
Qazvin
Province
Qazvin
Postal code
15315-34199
Phone
+98 28 3333 8034
Email
z.zarabadipour@qums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Vice-Chancellor for Research in Qazvin University of Medical SciencesDr. Amir Peymani
Street address
Shahid Beheshti Blvd., Deputy Minister for Research and Technology, Qazvin University of Medical Sciences
City
Qazvin
Province
Qazvin
Postal code
13911/34156
Phone
+98 28 3333 7006
Email
apeymani@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Zeinab Zarabadipour
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Shahid Bahonar Blvd. - Qazvin University of Medical Sciences
City
Qazvin
Province
Qazvin
Postal code
15315-34199
Phone
+98 28 3333 8034
Email
z.zarabadipour@qums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Zeinab Zarabadipour
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Shahid Bahonar Blvd. - Qazvin University of Medical Sciences
City
Qazvin
Province
Qazvin
Postal code
15315-34199
Phone
+98 28 3333 8034
Email
z.zarabadipour@qums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Zeinab Zarabadipour
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Shahid Bahonar Blvd. Qazvin University of Medical Sciences
City
Qazvin
Province
Qazvin
Postal code
ایران
Phone
+98 28 3333 8034
Email
z.zarabadipour@qums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available