Protocol summary

Study aim
Determining the effect of acupressure on the severity of acute migraine headache in patients referred to the emergency department
Design
Clinical trials with control group, with false intervention group, are randomized. 69 samples were randomly assigned in 3 groups and based on the software in 11 blocks and 6 blocks and 3 blocks in each group, 2 in group A (acupressure group), 2 in group B (sham group) and 2 in group Group C (control group). And in the triple block, there is one person from each group
Settings and conduct
For each compression point for 8 seconds, followed by 2 seconds of rest and repetition of this sequence for 3 minutes. After 24 minutes of massage, the pain will be recorded. The study area is located in Bouali Sari Hospital.
Participants/Inclusion and exclusion criteria
1- Previous diagnosis of migraine by a neurologist at least 6 months ago, 2- Being in the age range of 18-65 years, 3- Headache severity, according to the scale of VAS with a score of 4, are included in the study
Intervention groups
In the acupressure group, in addition to medication in the emergency department, to reduce the headache caused by migraine, 6 points of the body called ST.44 Neiting, Liv.3 Taiching, BL.2Cuanzhu, GB.14 Yanghabi GB.1Tong Zi Liao, SI .3 Houxi, Du 20 Baihui and LI.4Hegu will be pressed. For each compression point for 8 seconds, followed by 2 seconds of rest and repetition of this sequence for 3 minutes. For the control group, only the medication in the emergency department will be performed and for the sham group at 8 points, 2 cun above the group points The pressure intervention is applied. After 24 minutes of massage, the pain of the patients will be recorded
Main outcome variables
Acute migraine headache

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20110906007494N30
Registration date: 2019-06-17, 1398/03/27
Registration timing: registered_while_recruiting

Last update: 2019-06-17, 1398/03/27
Update count: 0
Registration date
2019-06-17, 1398/03/27
Registrant information
Name
Masoumeh Bagheri Nesami
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 7551
Email address
mbagheri@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-17, 1398/03/27
Expected recruitment end date
2019-09-18, 1398/06/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of acupressure on headache intensity of patients with acute migraine referred to emergency departments
Public title
The effect of acupressure on headache intensity of patients with acute migraine referred to emergency departments
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
معیارهای تشخیص انجمن بین المللی سر درد برای تشخیص سر درد میگرنی عبارتند از الف: سابقه حداقل 5 حمله، (ب) حملات سر درد به مدت 4 تا 72 ساعت ( 2 تا 4 ساعت در افراد زیر 15 سال)، (ج) حملات سر درد با دو علامت از قبیل یک طرفه، ضربان دار، شدت متوسط تا شدید (با ممانعت از فعالیت روزانه)، تشدید سر درد با بالا رفتن از پله یا فعالیت های مشابه، (د) وجود حداقل یکی از علائم از قبیل تهوع یا استفراغ یا هر دو و ترس از نور و صدا در زمان سر درد) می باشند International diagnostic criteria for diagnosis of migraine headaches include: A: history of at least 5 attacks; (b) headache attacks for 4 to 72 hours (2 to 4 hours in people under 15 years of age); (c) head attacks Pain with two signs, such as one-way, pulsating, moderate to severe severity (by inhibiting daily activity), exacerbation of headache by climbing the stairs or similar activities, (d) having at least one of the symptoms, such as nausea or vomiting Or both, and fear of light and sound at the time of headache)
Exclusion criteria:
International diagnostic criteria for diagnosis of migraine headaches include: A: history of at least 5 attacks; (b) headache attacks for 4 to 72 hours (2 to 4 hours in people under 15 years of age); (c) head attacks Pain with two signs, such as one-way, pulsating, moderate to severe severity (by inhibiting daily activity), exacerbation of headache by climbing the stairs or similar activities, (d) having at least one of the symptoms, such as nausea or vomiting Or both, and fear of light and sound at the time of headache)
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 69
Randomization (investigator's opinion)
Randomized
Randomization description
23 in the acupressure group, 23 in the control group and 23 in the sham group or false intervention for research. 69 samples were randomly assigned in 3 groups and based on the software in 11 blocks and 6 blocks and 3 blocks in each group, 2 in group A (acupressure group), 2 in group B (sham group) and 2 in group Group C (control group). And in the triple block, there is one person from each group
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Mazandaran University of Medical Sciences
Street address
Mazandaran University of Medical Sciences, Vice chancellor for research, Moalem street, Moalem square, Sari, Mazandaran, Iran.
City
sari
Province
Mazandaran
Postal code
4816715793
Approval date
2019-06-16, 1398/03/26
Ethics committee reference number
IR.MAZUMS.REC.1398.528

Health conditions studied

1

Description of health condition studied
The effect of acupressure on acute migraine pain
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Migraine headache
Timepoint
The effect of acupressure on the severity of migraine headache in patients referred to the emergency department
Method of measurement
( VAS) Visual Analogue Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:
Category
Treatment - Drugs

2

Description
Control group:
Category
Treatment - Drugs

3

Description
Control group:
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Buali Sari Hospital
Full name of responsible person
PURIA SEAYDI
Street address
Juibar three ways, Mazandaran University of Medical Sciences
City
SARI
Province
Mazandaran
Postal code
48157-33971
Phone
+98 11 3336 1985
Email
puriaems@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
University researches Assistance
Street address
Deputy of Research of Mazandaran University of Medical Sciences
City
SARI
Province
Mazandaran
Postal code
48157-33971
Phone
+98 11 3379 5508
Email
puriaems@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Sari 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
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Masoumeh Bagheri Nasami
Position
Ph.D. Nursing Education
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Research Assistant of Mazandaran University of Medical Sciences
City
sari
Province
Mazandaran
Postal code
48157-33971
Phone
+98 11 3379 5508
Email
puriaems@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Masoumeh Bagheri Nesami
Position
Nursing Ph.D
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Mazandaran University of Medical Sciences, three way Joibar, highway Basij, Imam square, Sari, Mazandaran
City
Sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 3379 5508
Email
Anna3043@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Sari University of Medical Sciences
Position
Nursing Ph.D.
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nasibe Nursing and Midwifery Faculty
City
SARI
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 3336 1985
Email
puriaems@yahoo.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
There is no further 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
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