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Clinical trial of comparing the effects of acupressure and touch in chihyin point on non- stress test parameters in primiparous women

Protocol summary

Summary
The aim of this research was to study the effects of acupressure on the results of non-stress test. The current research is a random, single blind, single stage, and single central study. First, 90 pregnant women (gestational age 37-41 weeks) and with non-troubling conditions were selected randomly for this study. The sampling method was simple and objective-based, so that the researcher substituted the alternative ones, if the first sample was excluded for any reasons. Then the remaining samples were randomly divided into two groups namely control and intervention. In case of any problems such as uterine contraction, placental abruption, etc. the samples were excluded. First, non- stress test was applied for all pregnant mothers for 10 min. Then, acupressure in Chyhyin point was performed for 10 min ( 30s acupressure and 10 s rest) without any interrupt. During this period, the non- stress test was continued and then the heart pulses were registered 10 min after acupressure completion. The same process was applied for the control group. The only difference was that in control group the researcher only touches the Chihyin point without performing acupressure. Finally , the non- stress test parameters including fetus heart rate baseline, fetus movements, number of heartbeat accelerations , and long term variability were compared between control and intervened groups.

General information

Acronym
BL67point
IRCT registration information
IRCT registration number: IRCT2013111815449N1
Registration date: 2014-01-14, 1392/10/24
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-01-14, 1392/10/24
Registrant information
Name
Rafat Ebadi
Name of organization / entity
Shiraz University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 71 1647 4252
Email address
ebadi_r@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2013-08-23, 1392/06/01
Expected recruitment end date
2014-01-20, 1392/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of comparing the effects of acupressure and touch in chihyin point on non- stress test parameters in primiparous women
Public title
Effects of acupressure in non-stress test
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria 1.Age range 18-35 years 2.Body mass index( B.M.I) of 18-25 3.Gestational age of 37-41 weeks 4.Primiparous with single fetus 5.Base heartbeat of 110-160 6.No mental disorders 7.No chronic diseases such as cardiac , pulmonic, renal, chronic hypertension, and diabetic 8.No intense exercise 2 hours before test 9.No smoking 10.At least 2 hours after nutrient consumption 11. No injuries and allergy in 5th toe Exclusion criteria 1. Any problems such as placental abruption, umbilical cord prolapse, etc. 2. Non-intention to continue the study 3. Existence of contractions
Age
To 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Shiraz University of Medical Sciences
Street address
Zand Avenue, Shiraz
City
Shiraz
Postal code
1975-71345
Approval date
2012-10-07, 1391/07/16
Ethics committee reference number
CT-92-6660

Health conditions studied

1

Description of health condition studied
Fetal health
ICD-10 code
O35
ICD-10 code description
Maternal care for known or suspected fetal abnormality and damage

Primary outcomes

1

Description
Baseline fetal heart rate
Timepoint
ten min before intervention, 10 min during intervention and 10 min after intervention consistently
Method of measurement
Fetal Monitoring Device

2

Description
Acceleration of fetal heart rate
Timepoint
ten min before intervention, 10 min during intervention and 10 min after intervention consistently
Method of measurement
Fetal Monitoring Device

3

Description
Fetal movements
Timepoint
ten min before intervention, 10 min during intervention and 10 min after intervention consistently
Method of measurement
Fetal Monitoring Device

4

Description
Long-term variability of fetal heart rate
Timepoint
ten min before intervention, 10 min during intervention and 10 min after intervention consistently
Method of measurement
Fetal Monitoring Device

Secondary outcomes

empty

Intervention groups

1

Description
Touching BL67 point in the control group without applying acupressure during intervention time.
Category
N/A

2

Description
Doing acupressure BL67 point in intervention group for 10 minutes
Category
Diagnosis

Recruitment centers

1

Recruitment center
Name of recruitment center
Hafez Hospital
Full name of responsible person
Ladan Humayun
Street address
chamran avenue, shiraz, Fars
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Gholamreza Hatam
Street address
Zand avenue, Shiraz
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Masumeh Kaviani
Position
Master of Midwifery
Other areas of specialty/work
Street address
Fatemeh (P.B.U.H) School Of Nursing & Midwifery, Shiraz.
City
Shiraz
Postal code
1975-71345
Phone
+98 71 1647 4252
Fax
Email
kavianm@sums.ac.ir
Web page address
www.sums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Nasrin Asadi
Position
Assistant
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences, Division of Obstetrics and Gynecology
City
Shiraz
Postal code
71345-1978
Phone
00
Fax
Email
nasadi2012@yahoo.ca
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Science
Full name of responsible person
Rafat Ebadi
Position
Student Master of Midwifery
Other areas of specialty/work
Street address
Fatemeh (P.B.U.H) School Of Nursing & Midwifery, Shiraz.
City
Shiraz
Postal code
713451978
Phone
Fax
Email
ebadi_r@sums.ac.irrafatebadi@yahoo.comrafatebadi@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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