Despite the availability of different kinds of analgesics, labor pain management still remains a challenge faced in most countries. Reflexology is an ancient, mild and non-invasive technique, used widely as one of the non-pharmacological methods for pain relief. The aim of this research was to determine the effect of reflexology on pain intensity as well as to determine the duration of labor on primiparas in Shahid Akbarabadi Hospital, Tehran, Iran. Methods: A randomized clinical trial study with three groups was conducted. A total of 120 parturient women with low risk pregnancy were randomly assigned to three groups. Each group received one of the following treatments: reflexology, support or routine care only. The first group received 40 minutes of reflexology at the beginning of active phase (4-5 cm cervical dilatation). Emotional support was offered for the second group in the same stage of pregnancy and with the same duration. The third group received only routine care during labor. In all groups pregnant women were asked to evaluate the severity of pain experienced before and after intervention; and also at cervical dilatations of 6-7 cm and 8-10 cm respectively.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138904183226N2
Registration date:2010-07-09, 1389/04/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-07-09, 1389/04/18
Registrant information
Name
Mahrokh Dolatian
Name of organization / entity
Shahid Beheshti University of Medical Scenices
Country
Iran (Islamic Republic of)
Phone
+98 21 8820 2512
Email address
m_dolatian@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2009-03-21, 1388/01/01
Expected recruitment end date
2009-09-23, 1388/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of reflexology on pain intensity of labor
Public title
The effect of reflexology on pain intensity of labor
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: primiparous, Iranian, age between 18-35 years, gestational age 37-42 weeks, cephalic presentation, without any history of infertility and indication of c/s, wanted pregnancy, low risk pregnancy. Exclusion criteria: emergency c/s.
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)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Beheshti University of Medical Sciences
Street address
City
Tehran
Postal code
Approval date
2010-02-24, 1388/12/05
Ethics committee reference number
87-01-86-6060
Health conditions studied
1
Description of health condition studied
labor pain
ICD-10 code
060-075
ICD-10 code description
Complications of labour and delivery
Primary outcomes
1
Description
intensity of labor pain
Timepoint
before and after intervention; and also at cervical dilatations of 6-7 cm and 8-10 cm
Method of measurement
visual numerical scale
Secondary outcomes
empty
Intervention groups
1
Description
First group (reflexology): 40 minutes of reflexology at the beginning of active phase (4-5 cm cervical dilatation).
Category
Treatment - Other
2
Description
Second group: emotional support in the same stage of pregnancy and with the same duration.
Category
Treatment - Other
3
Description
Third group: only routine care during labor.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Akbarabadi Hospital
Full name of responsible person
Mahrokh Dolatian
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of medical Sciences
Full name of responsible person
Dr.Farideh Yaghmaee
Street address
Adjacent to Mofid Pedatric Hospital, Shriati Street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Faculty of Nursing and Midwifery, Shahid Beheshti University of medical Sciences
Full name of responsible person
Mahrokh Dolatian
Position
MS in midwifery
Other areas of specialty/work
Street address
Adjacent to Mofid Pedatric Hospital, Shriati Street
City
Tehran
Postal code
Phone
+98 21 8888 3133
Fax
Email
mhdolatian@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Nursing and Midwifery, Shahid Beheshti University of medical Sciences
Full name of responsible person
Mahrokh Dolatian
Position
MS in midwifery
Other areas of specialty/work
Street address
Adjacent to Mofid Pedatric Hospital, Shriati Street
City
Tehran
Postal code
Phone
+98 21 8888 3133
Fax
Email
mhdolatian@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Mahrokh Dolatian
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)