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Comparing the effect of heat and cold therapy on outcomes of labor and satisfaction in primigravida women referred to the Kamali hospital in Alborz 2015

Protocol summary

Summary
This randomized control trial, single-blind, with control group and single-center study is designed for exterminating and comparing the effect of heat and cold therapy on outcomes of labor and satisfaction in primigravida women.One hundred twenty low risk parturient women are randomly divided to three groups: heat therapy, cold therapy and control groups. The main inclusion criteria consisted of nulliparous women, 18 to 35 years old, early active phase (3-4 cm dilatation), cephalic presentation, 37-41 weeks of gestation, and singleton pregnancy. exclusion criteria include pre diagnosed of psychological and anatomical disorders, indications for cesarean section, history of chronic pelvic pain, use of narcotics and sedative and skin diseases in intervention area. Intervention will apply in the form of heat and cold therapy in the first and second stages of labor. Outcome variables include pain severity in first stage (3-4, 5-6, 7-8 and 9-10cm dilatation) and second stage of labor with the McGill Pain linear scale, duration of the first, second and third stages of labor, fetal heart rate in the first stage, mode of delivery, Apgar score, the first lactation, hugging the baby after delivery and variables of maternal satisfaction. Finally the items listed in each of the three groups will be compared.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015031021020N1
Registration date: 2015-03-10, 1393/12/19
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-03-10, 1393/12/19
Registrant information
Name
Zahra Mehdizadeh Tourzani
Name of organization / entity
Alborz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 26 3433 6008
Email address
minouei@abzums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Chancellor of Alborz University of Medical Sciences
Expected recruitment start date
2015-03-06, 1393/12/15
Expected recruitment end date
2015-08-22, 1394/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of heat and cold therapy on outcomes of labor and satisfaction in primigravida women referred to the Kamali hospital in Alborz 2015
Public title
Compared the effect of heat and cold therapy on outcomes of labor
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria consisted of nulliparous women in the age range between 18-35 years, women in the active phase of labor (3-4 cm dilatation), cephalic presentation, gestational age between 37-41 weeks and being a singleton fetus without preset abnormalities. Exclusion criteria included pre diagnosed of psychological and anatomical disorders, pre diagnosed of chronic diseases, indications for cesarean section, abnormal fetal heart patterns, history of chronic pelvic pain, history of infertility in women or spouse, any problem created during labor, women's unwillingness to continue to heat or cold therapy, women who live apart from their spouses, use of narcotics in about 8 hours before of active labor and skin diseases, including any injury, inflammation and eczema in the region of using hot-cold therapy.
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: 120
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
Research Chancellor of Alborz University of Medical Sciences
Street address
Ninth Floor, Dara Building, North Yasaman, East Pune Avenue, 45 meter of Golshahr
City
Karaj
Postal code
Approval date
2015-02-02, 1393/11/13
Ethics committee reference number
2519365

Health conditions studied

1

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

Primary outcomes

1

Description
Severity of pain
Timepoint
First and second stage of labor
Method of measurement
McGill Pain linear scale

2

Description
Duration of stages of labor
Timepoint
First, second and third stages of labor
Method of measurement
Digital clock

Secondary outcomes

1

Description
Mother's satisfaction
Timepoint
Postpartum
Method of measurement
Questionnaire

Intervention groups

1

Description
In the first intervention group: In The heat therapy group will be used warm water bag during contraction in the first stage of labor for at least 60 minutes on the lower back, abdomen area and under abdomen and in second stage will be used warm water bag for at least 4 minutes on the perineum.
Category
Other

2

Description
In the second intervention group: In The cold therapy group will be used cold ice bag on the lower back, abdomen and under abdomen for 10 minutes once every 30 minutes during the first stage and and in second stage will be used cold ice bag on the perineum for 5 minutes every 15 minutes.
Category
Other

3

Description
In the control group: This group will be recived routine care of labor ward and a midwife will be with woman all the time.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Kamali Hospital
Full name of responsible person
Zahra Mehdizadeh Tourzani
Street address
Kamali Hospital, Kamali Street, Shohada Square, Shahid Beheshti Avenue
City
Karaj

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Chancellor of Alborz University of Medical Sciences
Full name of responsible person
Dr. Enayatollah Kalantar
Street address
Ninth Floor, Dara Building, North Yasaman, East Pune Avenue, 45 meter of Golshahr
City
Karaj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Chancellor of Alborz 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
Alborz University of Medical Sciences
Full name of responsible person
Zahra Mehdizadeh Tourzani
Position
Master of Midwifery/ Faculty member
Other areas of specialty/work
Street address
Nursing and Midwifery Faculty, First Golestan Street, Eshteraki Avenue, Above the Takhti Park, Baghestan Blv
City
Karaj
Postal code
31485/56
Phone
+98 26 3433 6008
Fax
+98 26 3431 9188
Email
z_mehdizadeh_t@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Zahra Mehdizadeh Tourzani
Position
Master of Midwifery/ Faculty member
Other areas of specialty/work
Street address
Nursing and Midwifery Faculty, First Golestan Street, Eshteraki Avenue, Above the Takhti Park, Baghestan Blv
City
Karaj
Postal code
31485/56
Phone
+98 26 3433 6008
Fax
+98 26 3431 9188
Email
z_mehdizadeh_t@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Zahra Mehdizadeh Tourzani
Position
Master of Midwifery/ Faculty member
Other areas of specialty/work
Street address
Nursing and Midwifery Faculty, First Golestan Street, Eshteraki Avenue, Above the Takhti Park, Baghestan Blv
City
Karaj
Postal code
31485/56
Phone
+98 26 3433 6008
Fax
+98 26 3431 9188
Email
z_mehdizadeh_t@yahoo.com
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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