Labor pain is one the of the worst pains women experience during their life and its one of the reasons of increase in Caesarean section incidents. Many ways to reduce this pain is invented, one of which is the injection of distilled water in sacrum area subcutaneously. The aim of this study is to evaluate the effect of this therapeutic method. This study is a double blinded clinical trial. 160 primigravid women were recruited into two groups, cases and controls. In cases group distilled water was injected subcutaneously in sacrum area while normal saline was used in controls group and the pain degree was measured using VAS method.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201202253547N2
Registration date:2012-03-04, 1390/12/14
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-03-04, 1390/12/14
Registrant information
Name
Mohammad Nadjafi-Semnani
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8863 9551
Email address
nadjafi@hbi.ir
Recruitment status
Recruitment complete
Funding source
Birjand University of Medical sciences
Expected recruitment start date
2006-12-22, 1385/10/01
Expected recruitment end date
2009-08-23, 1388/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Will Subcutaneous Injection of Distilled Water Lessen the Back Pain in
Active Phase of Labour
Public title
Will Subcutaneous Injection of Distilled Water Reduce the Back Pain in
Active Phase of Labour
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: term pregnancy, alive fetus and active phase of labour.
Exclusion criteria: preterm labour; fetal death; labour inducton (oxcytocin prostaglandin) and use of sedatives
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Etich committee of Birjand university of medical sciences
Street address
Moalem St.
City
Birjand
Postal code
9713667649
Approval date
2006-12-09, 1385/09/18
Ethics committee reference number
143
Health conditions studied
1
Description of health condition studied
Normal delivery
ICD-10 code
Z34
ICD-10 code description
Supervision of normal pregnancy
Primary outcomes
1
Description
Pain
Timepoint
At the begging of the study and minutes: 40, 60 and 90.
Method of measurement
Visual analogue scale
Secondary outcomes
1
Description
Demand for sedative
Timepoint
At the end of the study
Method of measurement
Questionaire
2
Description
Patient satisfaction from treatment
Timepoint
At the end of the study
Method of measurement
Questionaire
Intervention groups
1
Description
In controls group, normal saline was injected subcutaneously in sacrum area
Category
Placebo
2
Description
In cases group distilled water was injected subcutaneously in sacrum area.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr hospital
Full name of responsible person
Nahid Ghanbarzadeh
Street address
Birjand Valiasr hospital
City
Brjand
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Shairfzadeh
Street address
Ghafary street
City
Birjand
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Dr. Nahid Ghanbarzadeh
Position
Gynecologist-
Other areas of specialty/work
Street address
Birjand University of Medical Sciences
City
Birjand
Postal code
Phone
+98 56 1222 9129
Fax
Email
nghanbarzadeh@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr. Nahid Ghanbarzadeh
Position
Gynecologist
Other areas of specialty/work
Street address
Birjand University of Medical Sciences
City
Birjand
Postal code
Phone
+98 56 1222 9129
Fax
Email
nghanbarzadeh@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr. Mohammad Najafi Semnani
Position
Associate professor
Other areas of specialty/work
Street address
Birjand University of Medical Sciences
City
Birjand
Postal code
Phone
+98 56 1222 8499
Fax
Email
monadjafi@gmail .com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)