Determination Effect of Ear Acupressure on Pregnancy Hypertension in Pregnant Women Referring to Qazvin Kosar Medical Center
Design
This study is a randomized, controlled clinical trial.
Available sampling method
80 pregnant mothers with high blood pressure. The conditions of entry into the study are divided into four interventional and control groups.
Settings and conduct
In the intervention group, in addition to receiving the usual medical care of the hospital, for acupressure patients, the ear will be labeled with 6 seeds on the back of the ear for eight sessions, and the mothers press seeds 6 times a day for 1 minute to reach the threshold of pain, and twice a week to replace the seeds and control blood pressure. Each mother, 8 sessions, and each ear, 4 times., and their blood pressure will be measured and recorded at each visit after 15 minutes of rest.
Participants/Inclusion and exclusion criteria
entering Criteria
Pregnant women 32-20 weeks;
Hypertension 140/140 mmHg and higher without proteinuria;
Singleton pregnancy;
Having reading and writing;
Not having external ear disease.
Exit criteria
Pre-eclampsia, eclampsia and Hellp syndrome;
Systolic blood pressure equal to 160 mm Hg;
Diastolic blood pressure equal t or greater than 110 mmHg;
Having chronic diseases (diabetes, cardiovascular diseases, chronic blood pressure, etc.);
Having uterine contractions and vaginal bleeding;
Use of psychoactive substances and cigarettes and alcohol;
use of other methods of complementary medicine.
Intervention groups
40 patients in the intervention group and performing the intervention protocol in addition to the usual medical care for four weeks and control of blood pressure twice a week
40 patients in the control group and performing usual medical care for four weeks and control of blood pressure twice a week
Main outcome variables
Reduce blood pressure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190402043156N1
Registration date:2019-05-01, 1398/02/11
Registration timing:registered_while_recruiting
Last update:2019-05-01, 1398/02/11
Update count:0
Registration date
2019-05-01, 1398/02/11
Registrant information
Name
Ladan Keshtkar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3335 7946
Email address
l.keshtkar@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-21, 1398/02/01
Expected recruitment end date
2019-09-22, 1398/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of auriculotherapy on pregnancy hypertension in pregnant women
Public title
The effect of auriculotherapy on pregnancy hypertension in pregnant women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1. Pregnant women 32-20 weeks;2. Hypertension 140/140 mmHg and higher without proteinuria;3. Single pregnancy;4. Having reading and writing;5. Not having external ear disease.
2. Hypertension 140/140 mmHg and higher without proteinuria
3. Singleton pregnancy
4. Having reading and writing
5. Not having external ear disease
Exclusion criteria:
Age
From 18 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
For random assignment Considering that we have two therapies (acupuncture and conventional medical care), we will use the 4th block. There are six different modes for the four blocks:
(AaaA, aaAA, AaAa.aAaA, AaAA, AaAa.aAaA, AaaA, aAAa), different states are written on six cards and will be dropped inside a bag. By selecting 20 blocks of six blocks, the allocation process of 80 patients to the two groups before The study will be started.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients in both groups and clinic nurses will not be informed of the groups
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics committee of Qazvin univercity of medical sciences
Street address
Shahid Bahonar Blvd. - Qazvin University of Medical Sciences
City
Qazvin
Province
Qazvin
Postal code
3613645569
Approval date
2019-02-27, 1397/12/08
Ethics committee reference number
IR.QUMS.REC.1397.370
Health conditions studied
1
Description of health condition studied
Pregnancy Hypertension
ICD-10 code
O10-O16
ICD-10 code description
Oedema, proteinuria and hypertensive disorders in pregnancy, childbirth and the puerperium
Primary outcomes
1
Description
blood pressure
Timepoint
twice in a week for four weeks
Method of measurement
The arterial artery pressure in each session is measured by a mercuric barometric device (ABN) made in the country of Germany, calibrated every six months. In all cases, measurements will be made from the right arm and in the sitting position
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, in addition to receiving the usual medical care of the hospital, the acupressure acupressure of the ears will be carried out by the researcher in the form of a label with 6 seeds of Seid (to completely cover the line of hypertension) on the hypertension line behind the ear during 8 sessions and will ask the mother Take 6 times at least 1 minute on squeezed seeds to reach the threshold of pain, and twice a week to replace the seizable labels and control blood pressure. Each mother, 8 sessions, and each ear, 4 times the adhesives are replaced, and their blood pressure will be measured and recorded at each visit for changing the adhesive containing seeds after 15 minutes of rest.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Kowsar Medical Center
Full name of responsible person
Ladan Keshtkar
Street address
Taleghani Ave.Kowsar Medical Center
City
Qazvin
Province
Qazvin
Postal code
3413645569
Phone
+98 28 3323 6374
Fax
+98 28 3324 2661
Email
itkosar@qums.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
دکتر امیر پیمانی
Street address
Shahid Bahonar Blvd. Ghazvin University of Medical Sciences
City
Qazvin
Province
Qazvin
Postal code
3413645569
Phone
+98 28 3337 8077
Email
Info@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
Ladan Keshtkar
Position
nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Taleqani Ave. Kowsar Medical Center
City
Qazvin
Province
Qazvin
Postal code
3413645596
Phone
+98 28 3323 6374
Email
l.keshtkar@qums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Ladan Keshtkar
Position
nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Taleqani Ave. Kowsar Medical Center
City
Qazvin
Province
Qazvin
Postal code
3413645596
Phone
+98 28 3323 6374
Email
l.keshtkar@qums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Ladan Keshtkar
Position
nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Taleqani Ave. Kowsar Medical Center
City
Qazvin
Province
Qazvin
Postal code
3413645596
Phone
+98 28 3323 6374
Email
l.keshtkar@qums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Yes - There is 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
Title and more details about the data/document
The results of the data will be published as a article
When the data will become available and for how long
" the Access Period since 1399"
To whom data/document is available
Only for researchers working in academic and scientific institutions
Under which criteria data/document could be used
reserch
From where data/document is obtainable
l.keshtkar@qums.ac.ir
What processes are involved for a request to access data/document