My objective is to test the effects of aloe vera and calendula ointment on pain relief and wound healing of episiotomy. 111 women who have episiotomy will be randomly divided into 2 intervention and 1 control group. One of the Intervention groups will use aloe vera ointment the other group will use calendula ointment on episiotomy incision every 8 hours. Control group will not use anything on episiotomy incision. Our scale to check the pain reliving is VAS ruler. We check the pain before intervention then 4 and 8 hours and 5 days after intervention. Our scale to check the wound healing is REEDA table. We check the healing process before and 5 days after intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138805102248N2
Registration date:2010-12-09, 1389/09/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-12-09, 1389/09/18
Registrant information
Name
Fereshteh Jahdi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
00982188773073,00982182471404
Email address
f.jahdi@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2010-08-01, 1389/05/10
Expected recruitment end date
2011-01-30, 1389/11/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Influence of Aloe Vera and Calendula on wound healing and pain of episiotomy
Public title
Influence of Aloe Vera and Calendula on wound healing and pain relief of episiotomy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: being primiparous, Not having physical and psychological diseases, Not to use tobacco, drugs and alcohol. Exclusion criteria: heart, respiratory or renal disease, eclampsia and preeclampsia, history of allergies to special medicine, laceration, pregnancy membrane prolonged more than 24 hours, fast labor, drug addiction, vulva and vaginal symptomatic inflammation, creation of heamatoma in episiotomy during the first 24 hours, taking medication more than routine when admitted in hospital
Age
No age limit
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
111
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
School of Nursing and Midwifery, Iran University of Medical Sciences
Street address
In front of Khatam hospital, Yasemi street
City
Tehran
Postal code
19395/4798
Approval date
2010-07-19, 1389/04/28
Ethics committee reference number
1743704
Health conditions studied
1
Description of health condition studied
wound healing and pain of the episiotomy
ICD-10 code
O75.9
ICD-10 code description
Complication of labour and delivery, unspecified
Primary outcomes
1
Description
Pain intensity of episiotomy
Timepoint
before intervention then 4 and 8 hours and 5 days after intervention.
Method of measurement
Visual Analouge Scale
Secondary outcomes
1
Description
Healing of episiotomy
Timepoint
before intervention and 5 days after episiotomy
Method of measurement
REEDA Scale
Intervention groups
1
Description
Grope 1: mothers put aloe vera on episiotomy 3 times a day until 5 days after birth
Category
Treatment - Drugs
2
Description
Grope 2: mothers put calendula on episiotomy 3 times a day until 5 days after birth
Category
Treatment - Drugs
3
Description
Control group follow the routine of the hospital
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Lolagar hospital
Full name of responsible person
Farideh Egdampour
Street address
Khosh street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Motevalian, Vice Chancellor for research of Iran University of Medical Sciences
Street address
Shahid hemat highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
School of Nursing and Midwifery, Iran University of Medical Sciences
Full name of responsible person
Farideh Egdampour
Position
master of scince student
Other areas of specialty/work
Street address
Yagchian
City
Tabriz
Postal code
Phone
+98 41 1386 2165
Fax
Email
fa_egdampour@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery, Iran University of Medical Sciences
Full name of responsible person
Fereshte Jahdi
Position
master of scince in midwifery
Other areas of specialty/work
Street address
Next to the Mottahari hospital, Rashid yasmi street, Valiasr avenue
City
Tehran
Postal code
Phone
+98 21 8247 1000
Fax
Email
f.jahdi@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)