Comparison the effect of two methods of heat therapy and cold therapy on labor pain and delivery outcome in primigravida women referred to the Karaj hospital in 2014
The aim of this study is to determine the effect of two methods of heat therapy and cold therapy on labor pain and delivery outcome in primiparous women. This study is a randomized , single blind and multi-center with three groups. The study populations include primiparous women with singleton term pregnancies with cephalic presentation and without any medical problems or pregnancy complications. They don’t use any drug or method of analgesia and anesthesia and labor induction. The sample include 105 patients (three groups of 35 persons) will be randomly allocated into the following three group: experimental group (heat therapy, cold therapy) and control group (routine care). Intervention in heat group is use of heat bag put in the low back (at least 60 min inthe first stage of labor) and in the second stage put on perineum (at least 4 min).Intervention in cold group is similar but ice bag put that area for 10 min. For the control group will be done routine management. Assessment of pain in the first stage of labor will be done in 3-4cm cervical dilatation,6-7 cm and 9-10cm in three groups according to the McGill Pain index. Duration of the first, second and third stages of labor, type of delivery and neonatal Apgar score at 1 and 5 minutes after birth, perineal laceration and fetal heart tone in the first stage of labor, in three groups will be recorded
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201407115948N2
Registration date:2014-08-07, 1393/05/16
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-08-07, 1393/05/16
Registrant information
Name
Soheila Moghimi Hanjani
Name of organization / entity
Islamic Azad University Karaj Branch
Country
Iran (Islamic Republic of)
Phone
+98 21 7720 4224
Email address
soheila.moghimi@kiau.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Islamic Azad University of Karaj
Expected recruitment start date
2014-08-23, 1393/06/01
Expected recruitment end date
2014-12-22, 1393/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of two methods of heat therapy and cold therapy on labor pain and delivery outcome in primigravida women referred to the Karaj hospital in 2014
Public title
Effect of heat therapy and cold therapy on delivery outcome
Purpose
Supportive
Inclusion/Exclusion criteria
Iinclusion criteria:female18-35,pregnant women in active phase of labor,cephalic persentation,primipara with 37-41week gestational age,singleton pregnancy
Exclusion criteria: cephalo pelvic disproportion,history of choronic pelvic pain, Use of any drug or method of analgesia and anesthesia, induction of labor with Oxytocin,complication of labor(cord prolaps,placenta abraptio,abnormal position),history of infertility, abnormal fetal heart patterns, presence of any special medical condition (e.g. chronic diseases) and use of narcotic 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:
105
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad university Karj barnch
Street address
Crossroad of Moazen Blvd and Esteghlal Blvd, Rajaeeshahr, Karaj, Mailbox: 31485-313
City
Karaj
Postal code
31485-313
Approval date
2014-03-12, 1392/12/21
Ethics committee reference number
0064
Health conditions studied
1
Description of health condition studied
Out comes of delivery
ICD-10 code
z-37
ICD-10 code description
Delivery
Primary outcomes
1
Description
Labor pain intensity
Timepoint
Dilation 3-4,6-7,9-10 cm
Method of measurement
McGill pain questionnaire
2
Description
Duration of the first stage of labor
Timepoint
One time the start of labor until complete effacement and cervical dilatation
Method of measurement
According to minutes using the standard digital clock
3
Description
Duration of the second stage of labor
Timepoint
One time from full dilatation of cervix to departure of baby
Method of measurement
According to minutes using the standard digital clock
4
Description
Duration of the third stage of labor
Timepoint
One time from departure of baby to complete withdrawal of placenta
Method of measurement
According to minutes using the standard digital clock
5
Description
Type of delivery
Timepoint
One time after departure of baby
Method of measurement
Observed as a vaginal delivery, instrumental delivery and cesarean section
6
Description
Apgar score
Timepoint
At 1 and 5 minutes after birth
Method of measurement
Observation and examination
Secondary outcomes
1
Description
Fetal heart tone
Timepoint
Every half of time
Method of measurement
Sounic aid and digital clock
2
Description
perineal laceration
Timepoint
after delivery
Method of measurement
observation and examination
Intervention groups
1
Description
In heat therapy group:in the first stage ,heat bag put in the low back(at least 1 hours) and the second stage put in perineum for 4 minutes
Category
Other
2
Description
In cold therapy group:ice bag put in the low back for 10 minutes in the first stage and on perineum in the second stage
Category
Other
3
Description
In control group:routin management
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Alborz hospital
Full name of responsible person
Soheila Moghimi Hanjani
Street address
Alborz hospital, Parastar Blvd, Western Baghestan, Mianjadeh
City
Karaj
2
Recruitment center
Name of recruitment center
Bahonar hospital
Full name of responsible person
Zahra Meddizadeh Toorzani
Street address
Specialized Bahonar hospital, Azimieh three-way
City
Karaj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Islamic Azad University of Karaj branch
Full name of responsible person
Ahmad Jahan Latibary
Street address
Vice chancellor for research, Islamic Azad University of Karaj branch, Crossroad of Moazen Blvd and Esteghlal Blvd, Rajaeeshahr
City
Karaj
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, Islamic Azad University of Karaj branch
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
Islamic Azad University Karaj branch
Full name of responsible person
Soheila Moghimi Hanjani
Position
Master of midwifery
Other areas of specialty/work
Street address
Crossroad of Moazen Blvd and Esteghlal Blvd, Rajaeeshahr, Karaj, Nursing & midwifery faculty
City
Karaj
Postal code
Phone
+98 26 3418 2579
Fax
Email
soheila.moghimi@kiau.ac.irsomoghimi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University Karaj branch
Full name of responsible person
Soheila Moghimi Hanjani
Position
Master of midwifery
Other areas of specialty/work
Street address
Crossroad of Moazen Blvd and Esteghlal Blvd, Rajaeeshahr, Karaj, Nursing & midwifery faculty
City
Karaj
Postal code
Phone
+98 26 3418 2579
Fax
Email
soheila.moghimi@kiau.ac.ir somoghimi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University Karaj branch
Full name of responsible person
Zahra Mehdizadeh Toorzani
Position
Master of midwifery
Other areas of specialty/work
Street address
Crossroad of Moazen Blvd and Esteghlal Blvd, Rajaeeshahr, Karaj, Nursing & midwifery faculty
City
Karaj
Postal code
Phone
+98 26 3418 2579
Fax
Email
z_mehdizadeh_t@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)