Comparison of the effect of pulse electro magnetic field with placebo on the amount of post cesarean section pain in pregnant women admitted in Arash hospital
The aim of this trial is to compare the effect of pulse electromagnetic on the post cesarean section pain. This study is conducted with the method of random trial and based on a double blinded for test groups and researchers.it is conducted in one center,” Arash Hospital”. among the admitted women for cesarean section, 46 of them were selected based on inclusion criteria. Inclusion criteria: the first and second Optional cesarean section applicant pregnant women between 20-35 years of age in their 37-42 weeks of pregnancy. Those participants who are uncooperative; have underlying Medical disease; had a previous abdomen surgery and are on special drugs will exclude of the trial. Then they will be assigned to either placebo or the electromagnet pulse recipient groups. The electromagnetic pulse device or the placebo will be immediately place on the incision of the patient continuously for a 10 day period. In this way, the number of patient’s pain on the first hours and next days after the cesarean section up to 10 days period will be measured via a visual analogue scale. At the end of the study, in addition to the effects of this device on relieving the post cesarean section pain, edema and immediately going back to normal work condition and the side effects will be measured and these cases will be compared with pharmacological drugs.
General information
Acronym
PEMF
IRCT registration information
IRCT registration number:IRCT2014070711020N3
Registration date:2014-08-02, 1393/05/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-08-02, 1393/05/11
Registrant information
Name
Maryam Khoshideh
Name of organization / entity
Tehran University of Medical Sciences, Arash Hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 7788 0909
Email address
khooshide@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran Medical University
Expected recruitment start date
2014-07-12, 1393/04/21
Expected recruitment end date
2014-11-01, 1393/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of pulse electro magnetic field with placebo on the amount of post cesarean section pain in pregnant women admitted in Arash hospital
Public title
Assessment of the effect of electromagnet on the reduction of cesarean section pain
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: First and second Optional C-section applicant pregnant women:20-35 years old: 37-42 weeks of pregnancy: single pregnancy.
exclusion criteria:previous underlying medical disease or abdominal surgery; Being on special drugs; patients' non-cooperation
Age
From 20 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
46
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
Ethics committee of Tehran University of Medical Sciences
Street address
Qods St, Keshavarz Blvd
City
Tehran
Postal code
Approval date
2014-07-17, 1393/04/26
Ethics committee reference number
940/130/د/93
Health conditions studied
1
Description of health condition studied
Pain
ICD-10 code
S31.7
ICD-10 code description
Multiple open wounds of abdomen, lower back and pelvis
Primary outcomes
1
Description
post cesarian section pain
Timepoint
3 period of 2 hours and 3 period of6 hours in the first day and then once every three days up to the 10th day after CS
Method of measurement
visual analogue scale
2
Description
Discharge of the incision of cesarin section
Timepoint
The first 10 days after cesarin section
Method of measurement
observentional
3
Description
peri incisional edema
Timepoint
the first 10 days after CS
Method of measurement
physician visit and patient report
Secondary outcomes
1
Description
Immediately going back to normal work
Timepoint
The first 10 days after cesarin section
Method of measurement
Patient report
Intervention groups
1
Description
using Pulse electro magnetic field on the cesarin section incision for the first 10 days after cesarin section in intervened group.
Category
Treatment - Other
2
Description
using placebo device in cesarian incision for the 10 firts days after post cesarian section in control group.This device is similar to pulse electro magnetic device and dose not make any pulse.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Arash Women's Hospital
Full name of responsible person
Dr Maryam Khooshide
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Tehran University of Medical Sciences , Deputy of Research
Full name of responsible person
Dr. Akbar Fotohi
Street address
Qods St, Keshavarz Blvd
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 Tehran University of Medical Sciences , Deputy of Research
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
Tehran University of Medical Sciences
Full name of responsible person
Dr Maryam Khooshide
Position
Associate professor
Other areas of specialty/work
Street address
Arash Women 's Hospital
City
Tehran
Postal code
Phone
+98 21 7788 3288
Fax
Email
khooshide@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Maryam Khooshide
Position
Associate professor
Other areas of specialty/work
Street address
Arash Women 's Hospital
City
Tehran
Postal code
Phone
+98 21 7788 3288
Fax
Email
khooshide@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Seyede Sakine Latifi Rostami
Position
Gynecology Resident
Other areas of specialty/work
Street address
Arash Women 's Hospital, Rashid Ave, Resalat Highway, Tehranpars
City
Tehran
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)