The objective of this study is to investigate the effect of cold therapy on pain intensity and delivery outcome in primiparous women.
Inclusion criteria: Tendency to participate in the study; Singleton pregnancy between 37 and 41 weeks of gestation; Vortex presentation; Age of 18-35 years old and being primiparous.
Exclusion criteria :Lack of tendency to participate in the study;Disorder in delivery stages; Manual removal of placenta;Abnormal fetal heart rate patterns that lead to cesarean section.
Sample size: 72 people having the inclusion criteria will be selected and randomly divided into two groups. In the experimental group, a frozen gel pack will be used on the upper and lower sides of abdomen, lower side of waist, and perinea. Pain intensity of delivery stages, bleeding, Apgar score, and women's satisfaction will be measured.
Studies outcome: Effect of cold therapy on pain intensity and delivery outcome
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015022321200N1
Registration date:2015-07-02, 1394/04/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-07-02, 1394/04/11
Registrant information
Name
Roya Dakhilalah
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4254
Email address
dakhilalah@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2015-04-21, 1394/02/01
Expected recruitment end date
2015-06-22, 1394/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of cold therapy on pain severity and labor outcome of Nulliparous Women
Public title
The effect of cold therapy on pain severity and labor outcome
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Tendency to participate in the study; Singleton pregnancy between 37 and 41 weeks of gestation; Vortex presentation; Age of 18-35 years old and being primiparous.
Exclusion criteria :Lack of tendency to participate in the study;Disorder in delivery stages; Manual removal of placenta;Abnormal fetal heart rate patterns that lead to cesarean section.
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:
68
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
The ethic committee of Shiraz University of Medical Sciences
Street address
No 60 ,Zand street, Shiraz University of Medical Sciences,Shiraz, Iran
City
Shiraz
Postal code
Approval date
2015-01-07, 1393/10/17
Ethics committee reference number
CT-9370-7280
Health conditions studied
1
Description of health condition studied
Delivery
ICD-10 code
080.0
ICD-10 code description
Supervision of normal first pregnancy
Primary outcomes
1
Description
Pain severity
Timepoint
First,Second and third stage of labor
Method of measurement
Visual analogue scale
Secondary outcomes
1
Description
Duration of labor stages
Timepoint
Since labor addmision to full dilatation(first stage),since full dilatation to child birth(second stage),since child birth to placenta delivery(third stage)
Method of measurement
Per minute
2
Description
Perineal tears
Timepoint
Immediately after delivery.
Method of measurement
According to the standard definition of tearing the skin, perineum, vagina and cervix
3
Description
Childbearing Satisfaction
Timepoint
After delivery
Method of measurement
Mackey 's standard questionnaire
4
Description
Measurement of hemoglobin
Timepoint
Before and six hours after delivery
Method of measurement
Blood test
5
Description
Neonatal apgar score
Timepoint
First and fifth minutes after delivery
Method of measurement
Apgar score table
Intervention groups
1
Description
Intervention group:Cold therapy(freezed gel pack) on the fundus of the uterus, back and lower abdomen every 30 minutes for 10 minutes and every 10 minutes on perineum for 5 minutes.
Category
N/A
2
Description
control groupe: No intervention will be done
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Zeinab Hospital
Full name of responsible person
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Shiraz University of Medical Sciences
Full name of responsible person
Dr Basir Hashemi
Street address
No 60 ,Zand Street, Shiraz University of Medical Sciences,Shiraz,Iran
City
Shiraz
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 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
School of Nursing and Midwifery, Shiraz
Full name of responsible person
Sara Azima
Position
Master's degree in Midwifery, Faculty member
Other areas of specialty/work
Street address
Namazi Sq.
City
Shiraz
Postal code
Phone
+98 71 3647 4254
Fax
Email
azimas@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery, Shiraz
Full name of responsible person
Sara Azima
Position
Master's degree in Midwifery, Faculty member
Other areas of specialty/work
Street address
Namazi Sq.
City
Shiraz
Postal code
Phone
+98 71 3647 4254
Fax
Email
azimas@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of midwifery ,School of Nursing and Midwifery,Shiraz University of Medical Scientes, Shir
Full name of responsible person
Sara Azima
Position
Master's degree in Midwifery, Faculty member
Other areas of specialty/work
Street address
أNo 73,School of Nursing and Midwifery,Nemazee squair, Shiraz, Iran
City
Shiraz
Postal code
7193613119
Phone
+98 36474254
Fax
+98 36474252
Email
azimas@sums.ac.ir
Web page address
www.sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)