The aim of this study is to determine the effect of Cinnamon ointment on healing and pain from episiotomy wounds in women. In this triple blind clinical trial, 144 eligible women will be allocated into two, Cinnamon or placebo ointment, groups using block randomization with allocation ratio 1:1 and block sizes of 4 and 6 determined with a computerized program. The ointments will be produced by the pharmacist colleague in similar color and will be 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 use one finger of the ointment every 12 hours. The wound pain will be assessed using visual analogue scale (VAS) one hour after finishing episiotomy repair (before any intervention), 4±1 hours after using the ointments. Also at 8±1 hours after using the ointments and on the tenth day postpartum visit, the pain and healing (using REEDA scale in lithotomy position) will be assessed. In SPSS-ver. 13, ANCOVA will be used to compare post-intervention mean pain scores between the groups controlling the pre-intervention pain scores and student’s-t to compare the repair scores.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201211303706N18
Registration date:2012-12-13, 1391/09/23
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-12-13, 1391/09/23
Registrant information
Name
Sakineh Mohammad-Alizadeh-Charandabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3477 2699
Email address
alizades@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2013-02-19, 1391/12/01
Expected recruitment end date
2013-05-22, 1392/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of cinnamon (Cinnamomum zelanicum) on healing and pain of episiotomy among primigravid women: A Randomized Controlled Trial
Public title
The effect of cinnamon (Cinnamomum zelanicum) on healing and pain of episiotomy among primigravid women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: • being primipara • being literate • Access to telephone line • gestational age 37 to 42 weeks • Having a singleton live child • aged 20 to 35 years • Repair of Episiotomy incision by a provider with at least six months experience• willingness to participate in the study. • willingness and ability to continue coming to Alzahra or Taleghani hospital for the care
Exclusion criteria: • use of drugs or psychotropic substances (according to the woman or her physical records) • use of certain drugs (according to the participant) • history of diseases like systemic disease, cardiac, renal, pulmonary, coagulation disorders, immune deficiency, connective tissue disorders, diabetes, mental illness, haemophilia that may intervene with the healing • following a special diet • long-term rupture of amniotic sac (over 18 hours) • severe anaemia (haemoglobin less than 7) (based on haemoglobin assessed at admission) • history of hypersensitivity to certain drugs • extension of episiotomy (tears of grade 3 or 4) • operative delivery
Age
From 20 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
144
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
2012-12-03, 1391/09/13
Ethics committee reference number
91157
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
Severity of episiotomy pain
Timepoint
Befor intervention and 4±1 , 8±1 hours after intervention and ten days after intervention
Method of measurement
Visual analogue scale (VAS)
2
Description
Episiotomy healing wound
Timepoint
Pre intervention and 8±1 hour after intervention and ten days afer delivery