Protocol summary
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Study aim
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Comparison of the effect of acupressure and fluoxetine on physical and psychological symptoms of premenstrual syndrome
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Design
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Randomized controlled clinical trial, with parallel group
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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.
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Main outcome variables
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Physical and psychosomatic symptoms of premenstrual syndrome
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20190430043433N1
Registration date:
2019-05-11, 1398/02/21
Registration timing:
prospective
Last update:
2019-05-20, 1398/02/30
Update count:
1
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Registration date
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2019-05-11, 1398/02/21
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-05-22, 1398/03/01
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Expected recruitment end date
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2020-03-19, 1398/12/29
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Compare the effect of acupressure therapy and Fluoxetine on the symptoms of premenstrual syndrome: A randomized clinical trial
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Public title
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Acupressure therapy in premenstrual syndrome
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 35 years old
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Gender
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Female
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Phase
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3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
90
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-04-29, 1398/02/09
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Ethics committee reference number
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IR.QUMS.REC.1398.014
Health conditions studied
1
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Description of health condition studied
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Premenstural syndrome
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ICD-10 code
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N94.3
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ICD-10 code description
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Premenstrual tension syndrome
Primary outcomes
1
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Description
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Physical symptoms of premenstrual syndrome
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Timepoint
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Two months before the intervention, during the intervention, three months after the end of the intervention
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Method of measurement
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Daily Record of Severity of Problems chart
2
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Description
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Psychosomatic symptoms of premenstrual syndrome
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Timepoint
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Two months before the intervention, during the intervention, three months after the end of the intervention
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Method of measurement
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Daily Record of Severity of Problems chart
Intervention groups
1
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Description
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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)
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Category
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Treatment - Other
2
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Description
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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)
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Category
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Treatment - Drugs
3
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Description
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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.
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Category
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Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Qazvin University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available