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Effect of LI4 and LI11 Electro- acupressure on low back and pelvic pain in pregnant women

Protocol summary

Study aim
• Determination of electrical stimulation effect of LI4 and LI11 pressure points on lumbar and pelvic pain in pregnant women
Design
The present study was designed as a randomized double-blind clinical trial (intervention and control).
Settings and conduct
In this study, pregnant women referred to health centers in Bojin Zahra city who are eligible for inclusion in the study will be available after obtaining informed consent and obtaining written consent.Then, by filling out a demographic checklist, pregnancy, and completing the Roland Morris LBP and visual analogue questionnaire, people with a score above 12 in the Roland Morris LBP questionnaire and an equal score of more than 4 in the visual analogue will be included. Samples were randomly divided into control and intervention groups using randomized blocking method.In the intervention group, in addition to receiving routine prenatal care for 4 weeks, they receive acupressure twice a week through a two-channel tensile device at LI11, LI4 pressure points for 15 minutes, and information was obtained immediately by Roland Morris questionnaire and visual analogue questionnaire. After the intervention, each session in Venice will be reviewed and followed up at 2, 4, and 6 weeks after the intervention.
Participants/Inclusion and exclusion criteria
Having lumbopelvic pain Ages 18 to 35 years Gestational age 26-32 weeks Gravida 1 and singleton pregnancy
Intervention groups
The control group will receive standard prenatal care, and for the intervention group, in addition to standard prenatal care, twice a week for 4 minutes each and for 15 minutes will be electrically stimulated by a two-channel tensile device at Li4 and Li11 pressure points. Will find out.
Main outcome variables
Acupuncture, Hip and Back Pain, Pregnancy Age, Mother's Occupation, Age, Education, Pregnancy Age

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191209045673N1
Registration date: 2020-01-29, 1398/11/09
Registration timing: registered_while_recruiting

Last update: 2020-01-29, 1398/11/09
Update count: 0
Registration date
2020-01-29, 1398/11/09
Registrant information
Name
Parvaneh Alirezaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3441 2386
Email address
p.alirezaei@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-20, 1398/10/30
Expected recruitment end date
2020-06-18, 1399/03/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of LI4 and LI11 Electro- acupressure on low back and pelvic pain in pregnant women
Public title
Effect of LI4 and LI11 Electro- acupressure on low back and pelvic pain in pregnant women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women with lumbopelvic pain Gestational age 26 to 32 weeks Gravida 1 singleton Ages 18 to 35 years
Exclusion criteria:
Having mental disorders. Having skeletal muscle disorders. Use of psychotropic drugs. Using other pain relief techniques such as exercise in water, yoga and ... Skin lesions at acupuncture points.
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 108
Randomization (investigator's opinion)
Randomized
Randomization description
In the first step, the eligible samples will be selected who are willing to participate in the study, and then they will be divided into two groups (intervention and control) using block randomization.
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 Qazvin University of Medical Sciences
Street address
Shahid Beheshti, Ave, Mavedat, St
City
Qazvin
Province
Qazvin
Postal code
3415613911
Approval date
2019-12-07, 1398/09/16
Ethics committee reference number
IR.QUMS.REC.1398.213

Health conditions studied

1

Description of health condition studied
lumbopelvic pain
ICD-10 code
M 54.5
ICD-10 code description
Low Back pain

Primary outcomes

1

Description
lumbopelvic pain
Timepoint
Measurements of lumbopelvic pain before intervention and immediately after the intervention in each visit and followed up at 2, 4 and 6 weeks after the intervention.
Method of measurement
Using Roland Morris Low Back Pain Inventory and Visual Analogue Scal

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In this study there is an intervention group, for the intervention group in addition to standard prenatal care, twice a week for 4 weeks and each time for 15 minutes electrical stimulation by two-channel tensile device at pressure points Li4 and Li11 at They will find.
Category
Treatment - Other

2

Description
Control group: Standard Prenatal Care
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Comprehensive Health Centers in the city of Bouin Zahra
Full name of responsible person
Fatemeh Ranjkesh
Street address
School of Nursing and Midwifery, Qazvin University of Medical Sciences, Bahonar Ave.
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3333 6001
Email
F.ranjkesh@qums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Vice chancellor for research, Qazvin University of Medical Sciences
Street address
Vice Chancellor for Research and Technology, Qazvin University of Medical Sciences, Shahid Beheshti Blvd.
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3333 6007
Fax
+98 28 3335 6500
Email
F.ranjkesh@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
Fatemeh Ranjkesh
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Qazvin University of Medical Sciences, Bahonar Ave. Midwifery Translations of midwifery NounFrequency مامایی midwifery قابلگی midwifery, midwife Examples of Midwifery midwifery services Synonyms of midwifery Noun tocology obstetrics ob
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 33336001-5
Email
F.ranjkesh@qums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Fatemeh Ranjkesh
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Qazvin University of Medical Sciences, Bahonar Ave.
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 33336001-5
Email
F.ranjkesh@qums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Fatemeh Ranjkesh
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Qazvin University of Medical Sciences, Bahonar Ave.
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 33336001-5
Fax
+98 28 3323 7268
Email
F.ranjkesh@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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
All data contains code and is identifiable.
When the data will become available and for how long
1399
To whom data/document is available
Qazvin University of Medical Sciences
Under which criteria data/document could be used
If approved by Qazvin University of Medical Sciences
From where data/document is obtainable
Qazvin University of Medical Sciences
What processes are involved for a request to access data/document
Visit Qazvin University of Medical Sciences and submit a written application or request an email to F.ranjkesh@qums.ac.ir
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