The aim of this study is to determine the effect of Horse tail ointment on healing and the pain from episiotomy wounds in women. In this triple blind clinical trial, 108 healthy primiparous women aged between 18 – 35 with Mediolateral Episiotomy will be allocated into two, Horse tail or placebo ointment, groups using block randomization with allocation ratio 1:1 and block sizes of 4 and 6 were determined with a computerized program. The ointments will be produced by the pharmacist colleague in similar color and will put into similar tubes with no label. A person not involved in sampling and data collection will put the ointment tubes into sequentially numbered sealed opaque envelopes to conceal allocation sequence. After filling in baseline characteristics and measuring the episiotomy incision length, participants will sequentially get the envelops and will be asked to rub the ointment with her knucle on the wound every 12±2 hours. The wound pain and healing will be assessed using visual analogue scale (VAS and REEDA scale) before discharge of hospital (before any intervention),5±1and 10±1 day after using the ointments. (in lithotomy position). received data analysed statistical methods
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201305277618N5
Registration date:2013-07-29, 1392/05/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-07-29, 1392/05/07
Registrant information
Name
Soheila Bani
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6770
Email address
banis@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2013-07-11, 1392/04/20
Expected recruitment end date
2013-10-12, 1392/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Horse tail (Equisetum arvense) on healing and the pain of episiotomy among primiparous women: A Randomized Controlled Trial
Public title
The effect of Horse tail (Equisetum arvense) on healing and the pain of episiotomy among primiparous women: A Randomized Controlled Trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: healthy primiparous woman; having alive fetus; willingness to participate in the study; mediolatral episiotomy Exclusion criteria: women less than 18 and more than 35 years old; history of impaired wound healing disease, like systemic disease, cardiac, renal, pulmonary, coagulation disorders, immune deficiency, connective tissue disorders, diabetes,haemophilia ; mental illness; Anaemia in pregnancy (haemoglobin less than 11/5); multiple fetus ; macrosomia; malformed fetus; having early postpartum hemorrhage ; extent or large episiotomy (repair length 4-3 cm) ; Instrumental delivery ;manipulation and vaginal exam history after delivery
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:
108
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research deputy, Tabriz University of Medical Sciences
Street address
Golgasht street
City
Tabriz
Postal code
Approval date
2013-06-10, 1392/03/20
Ethics committee reference number
9242
Health conditions studied
1
Description of health condition studied
Episiotomy
ICD-10 code
O90.1
ICD-10 code description
Disruption of perineal obstetric wound
Primary outcomes
1
Description
Episiotomy healing wound
Timepoint
Before intervention) before discharge of hospital( and 5±1and 10±1 day after intervention