Protocol summary

Summary
The aim of this study is to compare turmeric and Povidone iodine solutions on episiotomy wound healing and pain relief in primiparous women in Alzahra Maternity Hospital in 2009. In this double blind clinical trial, 120 primiparous women who met inclusion criteria was randomly allocated into intervention or control group. Participants in the turmeric group used adequate amount of turmeric solution on perineal area 3 times daily for ten minutes for 10 days after delivery and in Povidone iodine group did the same application with Povidone Iodine solution. Pain was evaluated with visual analog scale and wound healing was assessed with REEDA scale primarily in 24 hours and 10 days after delivery.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138810193027N1
Registration date: 2009-07-03, 1388/04/12
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2009-07-03, 1388/04/12
Registrant information
Name
Fahimeh Sehhatie Shafaie
Name of organization / entity
Tabriz university of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6770
Email address
sehhatief@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz university of Medical Sciences
Expected recruitment start date
2009-07-03, 1388/04/12
Expected recruitment end date
2009-10-13, 1388/07/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of turmeric and betadine solution efficacy on episiotomy wound healing and pain relieif in Alzahra hospital in 2009
Public title
The comparison of turmeric and betadine solution efficacy on episiotomy wound healing and pain relieif in Alzahra hospital in 2009
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: First pregnancy or primparous, age between 20-30, any record of chronic or acute disease, No record of special medication or allergy to any substances, normal body mass index, pervious surgery or injury in perineal area, No prolonged bleeding after delivery, No prolonged labor or instrumentation, Normal episiotomy Exclusion criteria: No abscesses, hematoma, or infection in perineal aria in post partum, having sexual intercourse before ten days after delivery
Age
From 20 years old to 30 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)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tabriz university of Medical Sciences
Street address
Tabriz university of Medical Sciences, University St., Tabriz
City
Tabriz
Postal code
-
Approval date
empty
Ethics committee reference number
384/4/5

Health conditions studied

1

Description of health condition studied
Perineal wound care
ICD-10 code
O90.1
ICD-10 code description
Disruption of perineal obstetric wound

Primary outcomes

1

Description
episiotomy wound healing
Timepoint
24 hours and 10 days after delivery
Method of measurement
REED SCALE (Redness, echimosses, edema discharge, aproximation)

Secondary outcomes

1

Description
episiotomy pain relief
Timepoint
24 hours and 10 days after intervention
Method of measurement
VAS (vissual analog scale)

Intervention groups

1

Description
povidone iodine solution 3 times daily after toilet for ten minutues on perineal wound in ten days after delivery, topicaly
Category
Treatment - Drugs

2

Description
turmeric solution 2.5, %3 time daily after toilet for ten minutes on perineal wound in ten days after delivery topicaly
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Fahimeh Sehhatie Shafaie
Street address
Nursing and Midwifery faculty, Tabriz university of Medical Sciences, Tabriz
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Deputy of Tabriz university of Medical Sciences
Full name of responsible person
Dr Rashidi
Street address
Research Deputy of Tabriz university of Medical Sciences, Tabriz
City
Tabriz
Grant name
-
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy of Tabriz 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

Person responsible for scientific inquiries

Contact
Name of organization / entity
Research Deputy, Tabriz university of Medical Sciences
Full name of responsible person
Fahimeh Sehhatie Shafaie
Position
MS on Midwifery
Other areas of specialty/work
Street address
Nursing and Midwifery faculty, Tabriz university of Medical Sciences, Tabriz
City
Tabriz
Postal code
Phone
+98 41 1479 6770
Fax
+98 41 1479 6969
Email
sehhatief@tbzmed.ac.irfahimehsehhatie@yahoo.com
Web page address
http://www.tbzmed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Reasearch Deputy, Tabriz university of Medical Sciences
Full name of responsible person
Fahimeh Sehhatie Shafaie
Position
MS on Midwifery, Academic member
Other areas of specialty/work
Street address
Nursing and Midwifery faculty, Tabriz university of Medical Sciences, Tabriz
City
Tabriz
Postal code
Phone
+98 41 1479 6770
Fax
+98 41 1479 6969
Email
sehhatief@tbzmed.ac.irfahimehsehhatie@yahoo.com
Web page address
http://www.tbzmed.ac.ir

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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