This study was designed to determine the effect of acupressure on childbirth satisfaction in postdate women. In this single blind clinical trial, 120 pregnant women referred to Shahid Akbar Abadi hospital are enrolled randomly into three groups, acupressure, sham acupressure and control. The present study is performing in Shahid Akbar Abadi hospital in Tehran at the Iran University of Medical Science, from March 2015. Inclusion criteria: gestational age of 39-40 weeks; nulliparous women; bishop score< 4. Exclusion criteria: taking chemical or herbal drugs; discontinuing of the study by mother request. Acupressure is performed at the 3 acupoints, 6 spleen, 32 and 60 bladder for 30 minutes twice a day by the mother and the researcher. In the sham acupressure group, pressure is applied in ineffective points for 30 minutes in 2 times a day. In this study, primary outcome variable is childbirth satisfaction.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016030821904N2
Registration date:2016-05-13, 1395/02/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-05-13, 1395/02/24
Registrant information
Name
Fatemeh Mahmoudi Kohani
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 913 854 3127
Email address
f.mahmodi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2016-03-09, 1394/12/19
Expected recruitment end date
2016-05-21, 1395/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of acupressure on childbirth satisfaction in postdate women: a randomized controlled trial
Public title
Acupressure on childbirth satisfaction
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age of 18-35 years old; gestational age of 39-40 weeks based on LMP or ultrasound in first trimester; nulliparous women; single fetus with cephalic presentation; intact membrane; bishop score< 4; body mass index between 19/8 to 30; estimated fetal weight between (4000-2500 gr); low risk pregnancy; not having sexual intercourse 24 hours before and up to end of the study; not use of any kind of chemical drug or herb to start labor for 36 hours before study; non history of infertility.
Exclusion criteria: discontinuing of the study by mother request; taking chemical or herbal drugs.
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:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Science
Street address
Next to Taleghani hospital, Evin, Shahid Chamran Highway,Tehran
City
Tehran
Postal code
Approval date
2016-03-07, 1394/12/17
Ethics committee reference number
IR.SBMU.RAM.REC.1394.635
Health conditions studied
1
Description of health condition studied
Childbirth satisfaction
ICD-10 code
O94
ICD-10 code description
Sequelae of complication of pregnancy, childbirth and the puerperium
Primary outcomes
1
Description
Childbirth satisfaction
Timepoint
24 hours after delivery
Method of measurement
Mackey Childbirth Satisfaction Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The sham acupressure group: pressure is applied in ineffective point for 30 minutes in 2 times a day.
Category
Treatment - Other
2
Description
The intervention group: acupressure is applied in acupressure points 6 spleen, 32 and 60 bladder in 2 times daily for 30 minutes.
Category
Treatment - Other
3
Description
Control group: routine care
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Akbar Abaadi Hospital
Full name of responsible person
Nadia Hobi
Street address
Ferdose garden station, Molavi street, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Mostafa Rezaei Tavirani
Street address
Shahid Beheshti University of Medical Sciences, Velenjak St, Shahid Chamran Highway, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research of Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fatemeh Mahmoudi Kohani
Position
MS Stedent Midwifery
Other areas of specialty/work
Street address
Shahid Beheshti University of Medical Sciences, Velenjak St, Shahid Chamran Highway, Tehran
City
Tehran
Postal code
1985717443
Phone
+98 21 8820 2517
Fax
+98 21 2243 9889
Email
mahmodi2020@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nursing and Midwifery Shahid Beheshti University of Medical Sciences
Full name of responsible person
Shahnaz Tork Zahrani
Position
Academic Faculty Member
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Valiasr Ave, Tehran
City
Tehran
Postal code
1985717443
Phone
+98 21 8820 2517
Fax
Email
mahmodi2020@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fatemeh Mahmoudi Kohani
Position
MS Student Of Midwifery
Other areas of specialty/work
Street address
Shahid Beheshti University of Medical Sciences, Velenjak St, Shahid Chamran Highway, Tehran
City
Tehran
Postal code
Phone
+98 21 8820 2517
Fax
Email
mahmodi2020@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)