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The effect of heat and cold therapy on labor pain and outcomes in nuliparous women

Protocol summary

Summary
This study is a randomized control trial for determinating the effect of hot and cold therapy on labor pain and child birth outcomes in nuli parous women. One hundred twenty eight low risk parturient women are randomly divided to four groups: heat, cold, intermittent heat and cold and control groups. Inclusion criteria are: null parity, 18 to 35 years old, early active phase (3-4 cm dilatation), cephalic presentation, 37-41 weeks of gestation, and singleton pregnancy. Exclusion criteria are: CPD, history of chronic pelvic pain, IUFD, fetal distress, use of narcotic or sedative drugs, psychological disorders and skin diseases in intervention area. Pain severity is assessed in 3-4cm, 6-7 cm, 9-10 cm dilatations of cervix and second stage of delivery by VAS. Duration of first, second and third stage of labor, first and fifth minutes APGAR, FHR, delivery kind, perineum statues and mother satisfaction are assessed.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201108277422N1
Registration date: 2012-05-20, 1391/02/31
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-05-20, 1391/02/31
Registrant information
Name
Zhila Ganji
Name of organization / entity
Mazandaran University of Medical Scinces
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 7342
Email address
zhila.ganji@yahoo.com
Recruitment status
Recruitment complete
Funding source
Research chancellar of mazandaran university of medical scences
Expected recruitment start date
2011-09-06, 1390/06/15
Expected recruitment end date
2012-05-04, 1391/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of heat and cold therapy on labor pain and outcomes in nuliparous women
Public title
The effect of heat and cold therapy on labor pain and outcomes
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria consisted of women in the age range between 18-35 years-women was active labor (3-4 cm dilatation) - Cephalic presentation - gestational age between 37-41 weeks - being a singleton fetus -Exclusion criteria included disproportion between fetus and pelvic- a history of chronic pelvic pain - prolapsed cord - fetal death, abnormal fetal heart patterns, narcotic use, mental disorders and skin diseases are the interference region Randomization *
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 128
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
Research Chancellor of Mazandaran University of Medical Sciences
Street address
Moalem square
City
Sari
Postal code
481615793
Approval date
2011-09-04, 1390/06/13
Ethics committee reference number
H-89-26

Health conditions studied

1

Description of health condition studied
Labor
ICD-10 code
O80
ICD-10 code description
spontaneous vertex delivery

Primary outcomes

1

Description
severity of pain
Timepoint
first and second stage labor
Method of measurement
visual analog scale

Secondary outcomes

1

Description
duration of labor
Timepoint
first and second stage
Method of measurement
digital clock

2

Description
SATISFACTION OF LABOR
Timepoint
AFter labor
Method of measurement
queztionaier

Intervention groups

1

Description
1-In The heat therapy group warm water bag will be used for low back and abdominal area from cervix dilatation of 3-4 cm to the end of first laborduring contractions and for perinea at the second stage .
Category
Other

2

Description
2-in the cold therapy group ice water bag will be used for low back and abdomen from cervix dilatation of 3-4 cm to the end of first labor during contractions and for perinea at the second stage .
Category
Other

3

Description
3- IN the intermittent heat and cold therapy group warm water and ice water bag will be used intermittently for low back and abdomen from cervix dilatation of 3-4 cm to the end of first stage of labor during contractions and for perinea at the second stage .
Category
Other

4

Description
4-control grope will br recived rotin care. a midwife will be with woman all time.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Rajaei Hospital
Full name of responsible person
Zhila Ganji
Street address
Tonakabon
City
Tonakabon

2

Recruitment center
Name of recruitment center
Iimam Ali Amol Hospital
Full name of responsible person
Zhila Ganji
Street address
Chamestan Road
City
Amol

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Chancellor of Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Ahmadali Enayati
Street address
Moalem square
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Chancellor of Mazandaran 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
Nasibah Nursing and Midwifery School
Full name of responsible person
Zhila Ganj
Position
MSc
Other areas of specialty/work
Street address
Vasal street -Nasibah Nursing and Midwifery School
City
Sari
Postal code
481615793
Phone
+98 15 1226 7343
Fax
+98 15 1226 8915
Email
zhila.ganji@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Marjan Ahmad Shirvan
Position
MSc of Miwifery
Other areas of specialty/work
Street address
Nursing and Midwifery School Nasibeh
City
Sari
Postal code
481615793
Phone
+98 15 1226 7343
Fax
+98 15 1226 8915
Email
MAShirvani@mazuma.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Zhila Ganji
Position
MSc. of Midwifery
Other areas of specialty/work
Street address
Sari Nursing & Midwifery School
City
Sari
Postal code
Phone
00
Fax
Email
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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