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Comparison of the effects of supportive care for the mother and acupressure at BL32 point on the severity pain and outcome of labor in pregnant women

Protocol summary

Summary
This study is a randomized clinical trial on 150 women who had referred to Shoushtari hospital, Shiraz, Iran and compare the effect of supportive care for the mother and acupressure (the BL32) on the severity pain and outcome of labor in pregnant women is discussed. After obtaining informed consent, eligible women were allocated randomly into three groups (two experimental groups and one control group). In all three groups, the standard scale for measuring pain intensity, pain assessment (VAS) was used. The first group, the intervention was that the researcher was beside the mother since her entrance into the department, calmed and encourages the mother to be in positions to suit different stages of labor with cervical dilatation were performed. In the second group, in 3-4 and 7-8cm dilatation, the mother was placed in a proper position and BL32 point was pressed. The pressure was continuously and gently applied by both thumbs for 20 minutes. It was applied by the beginning and stopped at the end of the contractions. On the other hand, the control group only received the department’s routine care and underwent no interventions and was indirectly monitored. In all groups, pain intensity before and after the intervention, the progress of labor and delivery process was studied.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014011011706N5
Registration date: 2014-02-11, 1392/11/22
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-02-11, 1392/11/22
Registrant information
Name
Zahra Masoudi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1235 7282
Email address
masoudi_z@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Center for raditional Medicine and History of Medicine
Expected recruitment start date
2013-09-15, 1392/06/24
Expected recruitment end date
2013-11-15, 1392/08/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of supportive care for the mother and acupressure at BL32 point on the severity pain and outcome of labor in pregnant women
Public title
The impact of supportive care for the mother and acupressure at BL32 point on the severity pain and outcome of labor in pregnant women
Purpose
Supportive
Inclusion/Exclusion criteria
The inclusion criteria of the study were gestational age of 37-41 weeks based on the date of the last menstrual cycle or first and second trimester ultrasound; first or second pregnancy; mother's age between 18 and 35 years old; single pregnancy; head presentation; lack of obvious chromosomal abnormalities and fetal anomalies; not using any special drugs during pregnancy, and having at least middle school degree. Exclusion criteria of the study were maternal diabetes; growth restriction; Rh incompatibility; history of smoking; history of tobacco use; preeclampsia; oligohydramnios; placenta previa; placental abruption; thick meconium; suffering from any physical or mental disorder, and receiving any kind of medication including pethidine; hyoscine; oxytocin, and atropine.
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: 150
Randomization (investigator's opinion)
Randomized
Randomization description
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 in Medical Research, Shiraz University of Medical Sciences
Street address
Deputy of Research_Floor 7_University of Medical Sciences of Central Building_Zand Avenue_Shiraz
City
Shiraz
Postal code
71345-1978
Approval date
2013-09-15, 1392/06/24
Ethics committee reference number
CT_P_92_4985

Health conditions studied

1

Description of health condition studied
Pain intensity
ICD-10 code
R10.2
ICD-10 code description
Pelvic and perineal pain

2

Description of health condition studied
Outcome of delivery
ICD-10 code
Z37.0
ICD-10 code description
Single live birth

Primary outcomes

1

Description
Intensity pain
Timepoint
Before and After of intervention
Method of measurement
Visual Analoge Scale

Secondary outcomes

empty

Intervention groups

1

Description
The first group, the intervention was that the researcher was beside the mother since her entrance into the department, calmed and encourages the mother to be in positions to suit different stages of labor.Positions selected so as to avoid boredom and monotony of motherhood.
Category
Treatment - Other

2

Description
In the second group, in 3-4 and 7-8cm dilatation, the mother was placed in a proper position and BL32 point was pressed.The pressure was continuously and gently applied by both thumbs for 20 minutes. It was applied by the beginning and stopped at the end of the contractions.
Category
Treatment - Other

3

Description
The control group only received the department’s routine care and underwent no interventions.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shoushtari hospital
Full name of responsible person
Andishe Jorkesh
Street address
Shoushtari hospital_Corner of Hong
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Center for Traditional Medicine and History of Medicine
Full name of responsible person
Dr. Alireza Salehi
Street address
Shiaz Medical School Karimkhan Zand St
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Center for Traditional Medicine and History of Medicine
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

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz Medical School
Full name of responsible person
Dr. Maryam Kasraeian
Position
Expert Of Obstetricians and Gynecologists_Fellow Ship Of Perinatology_Assistant Professor
Other areas of specialty/work
Street address
Department Of Obestetrics And Gynecology_Medical School_Shiraz
City
Shiraz
Postal code
713451978
Phone
+98 71 1627 6411
Fax
Email
kasraeem@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zahra Masoudi
Position
Master student of midwifery
Other areas of specialty/work
Street address
Fatemeh (P.B.U.H) School Of Nursing & Midwifery_Shiraz
City
Shiraz
Postal code
7193613119
Phone
+98 71 1235 7282
Fax
Email
z.masoudi2007@yahoo.com; z.masoudi85@gmail.commasoudi_z@sums.ac.ir
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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