1. Home
  2. Approved trials
  3. » فارسی

The Effect of Acupressure on Points (LV3) on Non Stress Test Results, Mother Heart Rate and Blood Pressure in Pregnant Mothers

Protocol summary

Study aim
The effect of acupressure, point (LV3) on results of non-stress test, pulse and blood pressure of pregnant mothers
Design
Blind randomized,controlled trial, non-probabilistic, targeted sampling
Settings and conduct
To select research units, a non-probabilistic sampling method based on purpose and volunteer sampling method will be exploited. Accordingly, from among the patients who referred the emergency clinic of Bentolhoda hospital in Bojnurd, eligible individuals with informed consent and sufficient time and meet entry requirements elected. Blind: The NST strip is interpreted by a skilled and ignorant person to the objectives of the study.
Participants/Inclusion and exclusion criteria
Among those who had refered to the emergency clinic of Bentolhoda Hospital in Bojnurd, eligible people are selected for their informed consent, sufficient time and criteria for entering the study.
Intervention groups
Five minutes before the test, mother’s pulse and blood pressure were measured for the non stress test. It takes about 20 minutes. After 5 minutes, in the intervention group, the researcher will arrive at a pressure of 3 kg for 1 minute and rest for 30 seconds, and it takes 2.5 minutes for each leg. While the above point is under pressure and 5 minutes later, the heartbeat of fetus is monitored. In the control group, the researcher will only touch a point near the point LV3 (with a radius of 2 cm) that is not on the meridian path. After five minute the pulse and blood pressure of mothers are measured and the NST strip is interpreted by a specialist in the hospital and also by an expert that is unaware to the study objectives.
Main outcome variables
The effect of acupressure, point (LV3) on non stress test results, pulse and blood pressure of pregnant mothers

General information

Reason for update
Acronym
طب فشاری
IRCT registration information
IRCT registration number: IRCT20171209037795N1
Registration date: 2018-07-22, 1397/04/31
Registration timing: registered_while_recruiting

Last update: 2018-07-22, 1397/04/31
Update count: 0
Registration date
2018-07-22, 1397/04/31
Registrant information
Name
Maryam Bagheri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 58 3242 7442
Email address
bagherim@nkums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-08, 1396/12/17
Expected recruitment end date
2018-09-08, 1397/06/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Acupressure on Points (LV3) on Non Stress Test Results, Mother Heart Rate and Blood Pressure in Pregnant Mothers
Public title
The effect of acupressure on the Non Stress Test results
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
To participate in the research, you must be informed in writing. Age 18 to 35 years old. Have at least basic elementary education Pregnancy was first and single. The gestational age was 40 to 42 weeks. There is no medical problem. There is no maternity problem. Do not consume drugs or alcohol. No students or health care personnel. During pregnancy, do not have severe mental or physical problems.
Exclusion criteria:
If she had a contraction. The basic heart rate of the fetus is less than 110 beats per minute. The basic heart rate of the fetus is greater than 160 beats per minute Maternal blood pressure is greater than or equal to 140 to 90 mmHg. Mother's pulse is more than 100 beats per minute.
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 84
Randomization (investigator's opinion)
Randomized
Randomization description
First, a non-objective sampling method of purposeful sampling will be conducted among women who are willing to participate and criteria for entering the research.Then, according to the random number table, randomization will be done for each random sample, based on the set point on the random numbers table and determining the direction to the right if the number was read from the paired table to the control group and if the person It was entered into the intervention group.
Blinding (investigator's opinion)
Single blinded
Blinding description
After intervention in the intervention group and in the control group, after the test, NST (Non stress test) is interpreted by a specialist in the hospital and then by a skilled and unaware person for study purposes.
Placebo
Used
Assignment
Parallel
Other design features
The study has an intervention group that the researcher is doing non stress test on the mother a with pressure on LV3 point , and is performed routinely in the control group.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of North Khorasan University of Medical Sciences
Street address
Bojnurd Bentolhoda haspital
City
Bojnurd
Province
North Khorasan
Postal code
9415614963
Approval date
2017-12-27, 1396/10/06
Ethics committee reference number
ir.nkums.rec.1396.48

Health conditions studied

1

Description of health condition studied
Acupressure, LV3 point,fetus non stress test
ICD-10 code
P00-P96
ICD-10 code description
Certain conditions originating in the perinatal period

Primary outcomes

1

Description
Fetal non stress test result,
Timepoint
Pulse measurement and maternal blood pressure 5 minutes before the test and 5 minutes after intervention
Method of measurement
Pulse count, mercury pressure gauge machine

Secondary outcomes

1

Description
Mother's pulse and blood pressure
Timepoint
5 minutes before and after intervention
Method of measurement
Pulse count and mercurial blood pressure device

Intervention groups

1

Description
Intervention group: Mothers of the study will be asked to lie flat on the left side and after hearing of the heartbeat of the fetus and to ensure the absence of uterine contraction, stress-free test is performed for 20 minutes, after 5 minutes, in the intervention group, a researcher An equivalent of 3 kg will be given for 1 minute and rest for 30 seconds, and will be performed for a total of 2.5 minutes for each leg.
Category
Diagnosis

2

Description
Control group: The researcher will only touch the point near the point LV3 (2 cm radius) that is not on Meridian's path.
Category
Diagnosis

Recruitment centers

1

Recruitment center
Name of recruitment center
Bojnurd Bentolhoda Haspital
Full name of responsible person
Maryam Bagheri
Street address
Bentolhoda Haspital, Honar street,Bojnurd
City
بجنورد
Province
North Khorasan
Postal code
9415614963
Phone
+98 58 3241 4474
Email
bagherim@nkums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Maryam Bagheri
Street address
Bentolhoda Haspital
City
Bojnurd
Province
North Khorasan
Postal code
9415614963
Phone
+98 58 3241 4474
Email
bagherim@nkums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bojnourd 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
Bojnourd University of Medical Sciences
Full name of responsible person
Maryam Bagheri
Position
tutor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Bentolhoda Haspital
City
Bojnord
Province
North Khorasan
Postal code
9415614963
Phone
+98 32414474
Email
bagherim@nkums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Maryam Bagheri
Position
tutor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Bentolhoda Haspital
City
Bojnord
Province
North Khorasan
Postal code
9415614963
Phone
+98 58 3241 4474
Email
bagherim@nkums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Maryam Bagheri
Position
tutor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Bentolhoda Haspital
City
Bojnurd
Province
North Khorasan
Postal code
9415614963
Phone
+98 58 3241 4474
Email
bagherim@nkums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Title and more details about the data/document
Total data
When the data will become available and for how long
A year after printing results
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
Applying unidentifiable individual data
From where data/document is obtainable
Email
What processes are involved for a request to access data/document
Email request, plan explanation, answer
Comments
Loading...