Protocol summary

Study aim
The effect of taping therapy in primary Dysmenorrhea and Premenstrual syndrome in female students of Sardasht in 2019
Design
A randomized double-blind, before-after clinical trial
Settings and conduct
Participants will be followed for 3 cycles. In the first cycle, the sensitivity test was performed with a small piece of tape on hands, and in the next cycle, both groups had to inform the researcher about the menstrual cycle for 6 days. Installation of the tape in the Ava occupational therapy clinic by researcher who is also licensed to install the type In the Sardasht city of West Azerbaijan study area.
Participants/Inclusion and exclusion criteria
inclusion criteria:18-25 years, single, regular menstrual period (21-35 days), presence of primary menstrual pain in most menstrual cycles during the last 6 months, having a score of 4-10 Pain ruler, having at least one PMS diagnostic criteria, score below 92 based on MDQ questionnaire, no adverse events occurring in the last 6 months, no psychiatric medication, no type allergy, no history of any tendency to adhere to the tape, unwillingness to continue to cooperate, and significant change in one's lifestyle depending on his / her statement. exclusion criteria: Having any disease that affects the results of study, including mental illness and genital disease
Intervention groups
Intervention group: Kinesio tape adhesive strips have taped. After 5 days inform the researcher about the changeover to the clinic. It should be noted that the type stays on the skin does not interfere with their daily activities and since waterproof type will be used, there is no obstacle bathing with the type and this will be told to the students. This is done for 10 days. 5 days before and 5 days after menstruation. The control group will also receive a tape with a non-effect of Kinesio tape.
Main outcome variables
Primary Dysmenorrhea, Premenstrual Syndrome

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191218045790N1
Registration date: 2020-06-25, 1399/04/05
Registration timing: retrospective

Last update: 2020-06-25, 1399/04/05
Update count: 0
Registration date
2020-06-25, 1399/04/05
Registrant information
Name
Seyran Khezri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 4433 5574
Email address
seyran.khezri.m@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-22, 1398/04/01
Expected recruitment end date
2019-09-22, 1398/06/31
Actual recruitment start date
2019-06-22, 1398/04/01
Actual recruitment end date
2019-09-22, 1398/06/31
Trial completion date
2019-09-22, 1398/06/31
Scientific title
The effect of Taping Therapy in Primary Dysmenorrhea (PD) and Premenstrual Syndrome (PMS) in female students of Sardasht universities in 2018-2019
Public title
The effect of Taping Therapy in Primary Dysmenorrhea and Premenstrual Syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The age range 18-25 single Regular menstrual cycle (35-21 days) The existence of Early dysmenorrhea cramps in most menstrual cycles over the past 6 months Having 4-10 score, based on visual analog pain Scale Having a below score 92, based on the Menstrual Distress Questionnaire Do not take psychiatric medications Lack of sensitivity to tape No history of alcohol use No smoking Having at least one of the diagnostic criteria for premenstrual syndrome
Exclusion criteria:
Having any disease that affects the results of study, including mental illness and genital disease
Age
From 18 years old to 25 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 25
Actual sample size reached: 25
Randomization (investigator's opinion)
Randomized
Randomization description
In the first stage, out of 393 female students of Sardasht universities, we will determine eligible people to participate in the study based on the entry and exit criteria. The goal of the study and the probability of being assigned to intervention or control group will be explained to eligible participants in the study. If someone wishes to participate in the study, a written consent will be obtained consciously and based on the output of the following software, from the first to fiftieth people who have tended to participate in the study will be assigned to intervention and control groups by method of random blocking of 4. Eligible individuals will be assigned to control and intervention groups in 13 blocks of 4 people.
Blinding (investigator's opinion)
Single blinded
Blinding description
The participants will be told that they have been chosen in order to examine the effect of taping therapy on the severity of primary dysmenorrhea and premestrual syndrome. they will be divided into two random groups but without them noticing it. the intervention group will be provided with the real tape, but the control group will be provided with the similar tape without having real impact.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Orumieh University of Medical Sciences
Street address
Jihad Square, next to the emergency
City
Urmia
Province
West Azarbaijan
Postal code
1107894302
Approval date
2019-06-10, 1398/03/20
Ethics committee reference number
IR.UMSU.REC.1398.044

Health conditions studied

1

Description of health condition studied
Dysmenorrhea, premenstrual syndrome
ICD-10 code
N94.6
ICD-10 code description
Dysmenorrhea, unspecified, premenstrual syndrome

Primary outcomes

1

Description
Pain score on Visual Analogue Scale questionnaire
Timepoint
Measurement of Visual Analogue Scale at the beginning and end of the study
Method of measurement
Visual Analogue Scale, menstrual distress questionaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Keynesian tape is a waterproof tape without chemical adhesive. The 3NS TEX brand, made in Korea, measures 5 cm by 5 m. It is installed by a researcher for two menstrual cycles from 5 days before menstruation, after 5 days it is removed by the person and after 24 hours of skin respiration, Re-installed by the researcher and left on the site for another 5 days. In total, the tape is installed on the pain area for 10 days.
Category
Treatment - Other

2

Description
Control group: The actions taken for the intervention group are done exactly for the comparison group without real tape
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Azad University of Sardasht, Payame Noor University of Sardasht
Full name of responsible person
Seyran Khezri
Street address
Mellat Street, Second Alley, Miss Puri's Home
City
Sardasht
Province
West Azarbaijan
Postal code
2035846441
Phone
+98 44 4433 5574
Email
seyran.khezri.m@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Doctor Mohebbi
Street address
Jihad Square, next to the emergency110
City
Orumieh
Province
West Azarbaijan
Postal code
1102598712
Phone
+98 44 3275 5001
Email
Soheila80@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Soheila Rabipour
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Nazlou, Urmia University of Medical Sciences, School of Nursing and Midwifery
City
Urmia
Province
West Azarbaijan
Postal code
8202254554
Phone
+98 44 3275 5001
Email
Soheila80@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Seyran Khezri
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Mellat
City
Sardasht
Province
West Azarbaijan
Postal code
2333565984
Phone
+98 44 4433 5574
Fax
Email
seyran.khezri.m@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Seyran Khezri
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Mellat
City
Sardasht
Province
West Azarbaijan
Postal code
2335659870
Phone
+98 44 4433 5574
Fax
Email
seyran.khezri.m@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Loading...