The aim of study: Comparisonthe effect of hot bag water and eflorage massage in active phase of labor, on Pain severity in primiparous women. A Randomized(The use of sealed envelopes); not blinded, controlled, single-center, phase two trial. Inclusion criteria: the prediction of vaginal delivery with a normal history and physical examination by a medical team. . Exclusion criteria: Any reasons during the Labour, Start out of the labor and requiring special care or having an emergency cesarean section, Sensitivity to oil, Unwillingness to continue participation in the study. Sample size: 90. Type of Intervention:hot bag water, eflorage massage. Time involved: the active phase of labor and transitional. outcomes: reducing labor pain.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015090615338N3
Registration date:2015-10-19, 1394/07/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-10-19, 1394/07/27
Registrant information
Name
Shahnaz Golian Tehrani
Name of organization / entity
Nursing and Midwifery faculity
Country
Iran (Islamic Republic of)
Phone
+98 21 6650 4090
Email address
golian@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Science
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2015-12-22, 1394/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of hot bag water and eflorage massage in active phase of labor, on Pain severity in primiparous women
Public title
reducing labor pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: primiparous women with physical and mental health patients in the active phase; the prediction of vaginal delivery with a normal history and physical examination by a medical team; The Midwifery no problems in accepting the views of abnormal embryos, multiple pregnancies, fetal macrosomia, and pelvic disproportion, polyhydramnios, olygohydramnios, preeclampsia, premature placental separation, placenta previa, fast delivery and uterine infections; with a singleton pregnancy, cephalic view; no risk of hypertension, diabetes and other medical disorders in pregnancy; No risk of skin diseases like eczema, and any wound in the hot bag and massage; Having spontaneous contractions.
Exclusion criteria: All mothers of the natural course of maternal or fetal Labor Start due to factors such as detachment, cord prolapse, fetal distress out or for any reason during the Labor Start out of the labor and require special care or have an emergency cesarean section; Lack of desire to continue participating in the study; Use of drugs such as oxytocin labor catalyst; Use of an analgesic such as pethidine.
Age
From 18 years old to 35 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Tehran University of Medical Science
Secondary Ids
1
Registry name
golian
Secondary trial Id
46po
Registration date
1394-07-02, 777/01/-1356
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Central apartment of Tehran University of Medical Sciences, Keshavarz blvd
City
Tehran
Postal code
Approval date
2014-06-30, 1393/04/09
Ethics committee reference number
1525/130/d/93
Health conditions studied
1
Description of health condition studied
delivery
ICD-10 code
O00-O99
ICD-10 code description
Other obstetric conditions, not elsewhere classified