Protocol summary

Summary
this study is to determine the effect auriculotherapy on pain intensity, duration of active phase of labor and rate episiotomy in nulliparous women. In this randomized controlled clinical trial, 80 nulliparous pregnant women were assigned to two groups. Auriculotherapy was used for the case group, the control group received no intervention. Primiparous women in the study population Sina and Imam Khomeini Hospital, city of Ahvaz. Admission criteria samples gestational age 37-40 weeks, cephalic presentation, singleton pregnancy, 4 cm dilation and uterine contractions in 10 minutes, 30 seconds and 3-2, age between 18-35 years, have someone clean water (Intact) and exclusion criteria of the study: taking pain medications during the 3 hours before and during the study, history of infertility, use of oxytocin for induction or augmentation of labor are. Intervention techniques auriculotherapy by the investigator when the mother is in pain, and the pain is not the first time when the Bishop 4 and then Dilatation 6 and 8 cm, then sterilizing the ear,is on the auricle on points desired. the primary outcomes pain intensity and duration of the active phase of labor.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014101919591N1
Registration date: 2014-11-27, 1393/09/06
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-11-27, 1393/09/06
Registrant information
Name
Hoda Rastegar Zade
Name of organization / entity
Ahvaz Jondishapour University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3338 0295
Email address
rastegar.h@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
AJUMS
Expected recruitment start date
2014-10-30, 1393/08/08
Expected recruitment end date
2015-06-20, 1394/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Auriculotherapy effect on pain intensity, duration of active phase of labor and episiotomy rate in nulliparous women
Public title
Auriculotherapy effect on pain intensity, duration of active phase of labor and episiotomy rate
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: low risk pregnancy ; gestational age of 37-40 weeks ; cephalic presentation ; singleton pregnancy ; 4 cm dilation and uterine contractions in 10 minutes, 30 seconds and 3-2 ; age among 18-35 year ; 26.4 >BMI >19.8 ; have at least read and write ; having at least one healthy ear ; have someone clean water (Intact) Exclusion criteria of the study were to: receive pain medications during the 3 hours before and during the study ; drug addiction ; Athlete ; history of infertility ; the use of oxytocin for induction or augmentation of labor
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: 80
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
Ahvaz Jondishapour University of Medical Sciences
Street address
Ahvaz, Golestan Highway, University of Medical Sciences Jondishapour Ahvaz
City
Ahvaz
Postal code
61357-15794
Approval date
2014-09-28, 1393/07/06
Ethics committee reference number
ajums.REC.1393.190

Health conditions studied

1

Description of health condition studied
pain
ICD-10 code
O80.0
ICD-10 code description
spontaneous vertex delivery

2

Description of health condition studied
delivery
ICD-10 code
080.9
ICD-10 code description
spontaneous delivery,Single unspecified

Primary outcomes

1

Description
Severity of labor pain
Timepoint
Beginning of the active phase of dilatation of 6 cm and 8 cm
Method of measurement
visual analogue scale

2

Description
The duration of the active phase
Timepoint
During the first stage of labor
Method of measurement
Time recorded by the investigator

3

Description
episiotomy rate
Timepoint
In time of delivery
Method of measurement
recorded by the investigator

Secondary outcomes

1

Description
Durationof the second stage of labor
Timepoint
During the second stage of labor
Method of measurement
During the second stage of labor

2

Description
Duration of the third stage of labor
Timepoint
During the third stage of labor
Method of measurement
During the third stage of labor

Intervention groups

1

Description
In the intervention group: Auriculotherapy / three times / in the active phase of labor / in Dilatation 4 cm and 6 cm and 8 cm
Category
Treatment - Other

2

Description
In the control group :does not intervention / monitoring
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Hoda Rastegarzade
Street address
Iran, Ahvaz, Kut Abdullah Road, Not far from the Alley station, Sina Hospital
City
Ahvaz

2

Recruitment center
Name of recruitment center
Emam khomeini Hospital
Full name of responsible person
Hoda Rastegarzade
Street address
Iran, Ahvaz, street twenty-four meters, Imam Khomeini Hospital
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Ahvaz JundiShapur University of Medical Sciences
Full name of responsible person
Dr. Seid Ahmad Hosseini
Street address
Ahvaz Jundishapur University of Medical Sciences, opposite the central building, Vice Chancellor for Research, Ahvaz University of Medical Sciences
City
Ahvaz
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, Ahvaz JundiShapur 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
Ahvaz Jondishapour University of Medical Sciences
Full name of responsible person
Hoda Rastegar Zade
Position
Master of Midwifery
Other areas of specialty/work
Street address
Ahvaz, Golestan Highway, Ahvaz Jondishapour University of Medical Sciences, School of Nursing and Midwifery
City
Ahvaz
Postal code
61357-15749
Phone
+98 61 3373 8331
Fax
+98 613738333
Email
rastegar.h@ajums.ac.irmidrastegar@gmail.com
Web page address
-

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jondishapour University of Medical Sciences
Full name of responsible person
Hoda Rastegar Zade
Position
Master of midwifery
Other areas of specialty/work
Street address
Iran, Ahvaz, Golestan Highway, Ahvaz Jondishapour University of Medical Sciences, School of Nursing and Midwifery
City
Ahvaz
Postal code
61357-15794
Phone
+98 61 3373 8331
Fax
+98 61 3373 8333
Email
rastegar.h@ajums.ac.irmidrastegar@gmail.com
Web page address
-

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jondishapour University of Medical Sciences , school of nursing and midwifery
Full name of responsible person
Hoda Rastegar Zade
Position
Master of Midwifery
Other areas of specialty/work
Street address
Iran, Ahvaz, Golestan Highway, Ahvaz Jondishapour University of Medical Sciences, School of nursing and midwifery
City
Ahvaz
Postal code
61357-15794
Phone
+98 61 3373 8331
Fax
+98 61 3373 8333
Email
rastegar.h@ajums.ac.irmidrastegar@gmail.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
Loading...