The effect of Transcutaneous Electrical Acupoint stimulation on menstrual migraine.
Design
.This experimental study is a pre- and post-control. The sample size is 60. Convenience sampling will be done. In order to prevent bias, in this study, simple randomization will be used to perform random allocation and then will be randomly divided into one intervention group and two control groups.
Settings and conduct
Patients are referred to psychiatrists and midwives in clinics in Kermanshah.
Sampling is done at Sleep Disorders Research Center of Kermanshah University of Medical Sciences, Farabi Hospital. Intervention for each individual for 6 sessions at least 3 days before menstruation, during menstruation and after menstruation for two consecutive cycles in each session. , 5 minutes Acupuncture points are performed for 50 seconds by a student under the supervision of an acupuncturist.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1) having migraine headache during menstrual phase
Exclusion criteria: 1) painkillers and hormone medication during menstruation.
Intervention groups
Individuals are randomly divided into three groups.
The intervention group consisted of 20 patients and two control groups of 40 persons.
Intervention According to the results of Ahwaz migraine headache questionnaire, the headache status of the patients is determined before the intervention. In the acupuncture treatment group for acupuncture skin acupuncture in the six points, HT7 Shen I in the hands, Sanjiano SP6 in the medial ankle, and L14 Hugo in the thumb and forearm. But in the first control group the same acupuncture points without electrical stimulation are performed by simply touching the pen and in the second control group the acupuncture is performed by the device on non acupuncture points.
Main outcome variables
Menstrual Migraine Headache.
General information
Reason for update
Acronym
TEAS
IRCT registration information
IRCT registration number:IRCT20191016045129N1
Registration date:2020-01-04, 1398/10/14
Registration timing:retrospective
Last update:2020-01-04, 1398/10/14
Update count:0
Registration date
2020-01-04, 1398/10/14
Registrant information
Name
Faezeh Malekshahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3835 2689
Email address
malkshahi2000@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-23, 1398/08/01
Expected recruitment end date
2019-12-22, 1398/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Transcutaneous Electrical Acupoint stimulation on women menstrual migraine.
Public title
The effect of acupuncture on menstrual migraine
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Having a migraine headache in the menstrual phase
Willingness to participate in the study
Exclusion criteria:
Having a physical illness
Use of painkillers and hormones during menstruation
Age
From 15 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In order to prevent bias, in this study, simple randomization method will be used to perform random allocation. By making 60 cards that are matched in appearance, there are 20 cards on the 1 that indicate the intervention group, 20 on the other two, 2 on the first control group and 20 on the other 20. We describe the second control group. Each eligible person then randomly picks up one of these cards on which the code is written, which determines how patients will be randomly assigned to each group.
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 Kermanshah University of Medical Sciences
Street address
No. 7, Alley chaghakaboudi , Shahid Sq, Elahie Street
City
kermanshah
Province
Kermanshah
Postal code
6719946178
Approval date
2019-09-17, 1398/06/26
Ethics committee reference number
IR.KUMS.REC.1398.690
Health conditions studied
1
Description of health condition studied
Menstrual migraine
ICD-10 code
G43.82
ICD-10 code description
Menstrual migraine, not intractable
Primary outcomes
1
Description
Severity or extent of menstrual migraine
Timepoint
Before and after the intervention
Method of measurement
Ahwaz Migraine Headache Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group at least 3 days before menstruation, during menstruation and after menstruation for two consecutive cycles during six sessions, the student performed acupuncture dermal acupuncture.
Category
Rehabilitation
2
Description
Control group:In the first control group, at least 3 days before menstruation, during menstruation and after menstruation for two consecutive cycles during six sessions, the acupuncture points are touched only by the device without the stimulator.
Category
Rehabilitation
3
Description
Control group: In the second control group, at least 3 days before menstruation, during menstruation and after menstruation for two consecutive cycles during six sessions, the student performed electrical stimulation of the shunt at non-acupuncture points.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Farabi Hospital, Sleep Disorders Clinic
Full name of responsible person
Faezeh malekshahi
Street address
No. 7, Alley Chaghakaboudi , Shahed Square, Elahieh Street
City
kermanshah
Province
Kermanshah
Postal code
6719946178
Phone
+98 83 3835 2689
Email
Malkshahi2000@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Kermanshah University of Medical Sciences
Street address
No. 7,Alley Chaghakaboudi, Shahid Sq , Elahie Street
City
kermanshah
Province
Kermanshah
Postal code
6719946178
Phone
+98 83 3835 2689
Email
Malkshahi2000@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Faezeh Malekshahi
Position
University student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No .7, Alley chaghakaboudi , Sq shahed , elahiye street
City
kermanshah
Province
Kermanshah
Postal code
6719946178
Phone
+98 83 3835 2689
Email
Malkshahi2000@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Faezeh Malekshahi
Position
University student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No.7, Alley chaghakaboudi , Sq shahed , street elahiye
City
kermansha
Province
Kermanshah
Postal code
6719946178
Phone
009883338352689
Email
Malkshahi2000@gmail .com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Faezeh Malekshahi
Position
University student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 7, Alley Chaghakaboudi , Shahed Square, Elahieh Street
City
kermanshah
Province
Kermanshah
Postal code
6719946178
Phone
+98 83 3835 2689
Email
Malkshahi2000@gmail.com
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