Episiotomy is the most common painful surgeries in women that needs to be repaired. The prevalence of episiotomy in Iran is very high. It has a negative effect on the performance of the first experience of motherhood and relationship between the mother and baby. Delays in repairing increases the risk of infection, limited mobility and sexual dysfunction. For relieving of perineal pain after episiotomy and accelerating of wound healing, various methods have been proposed . The Mucilage in aloe vera leaf tissue, are used for medical purposes. The aim of this study is to evaluate the effect of aloe vera gel on episiotomy pain and wound healing. The participants in this study includes 70 women with singleton pregnancies and full-term nulliparous without any disorder. If anybody have any allergies, trauma and infection will exit from study. The intervention group will receive treatment twice daily for ten days and - Aloe Vera gel is Asans- Barij company- and is expected significant improvement in wound healing and reduce the pain after ten days . Because of the highe prevalence of episiotomy in Iran and it's influence on main activities, author decided to study the effect of Aloevera gel on prineal pain & wound healing after episiotomy in primi para women.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201604256888N14
Registration date:2016-07-11, 1395/04/21
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-07-11, 1395/04/21
Registrant information
Name
Fatemeh Shobeiri
Name of organization / entity
Hamadan Universiy of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1827 6051
Email address
shobeiri@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamadan university of medical sciences
Expected recruitment start date
2016-07-22, 1395/05/01
Expected recruitment end date
2016-11-21, 1395/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Aloevera gel on prineal pain & wound healing after episiotomy in primi para women
Public title
The effect of Aloevera gel on prineal pain & wound healing after episiotomy in primi para women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: primiparus؛ having single pregnancy, episiotomy without rupture and without using device؛ gestational age between 37-42 weeks؛ No history of systemic diseases such as chronic diseases, cardiovascular disease, respiratory disease, connective tissue coagulation disorders, diabetes, anemia, immune deficiency and ... ؛ The absence of allergy or hypersensitivity (allergic) reactions to topical medication in the past؛ The lack of underlying disease, eclampsia, and preeclampsia in pregnancy؛ No rupture of membranes more than 24 hours؛ lack of prolonged labor؛ Lack of drug addiction؛ lack of vulvar and vaginal symptoms of inflammation, a normal BMI؛ Having mediolateral episiotomy and stitches it with the size of 3-5 cm and separate and cut Goth thread, number zero
Exclusion criteria: not taken properly (Aloe Vera) after delivery؛ the incidence of allergy (rash, redness and swelling) and infections؛ incidence of new trauma for any reason at length study
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
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
Ethics Committee of Hamadan University of Medical Sciences
Street address
Fahmiheh Street, Hamadan University of Medical Sciences, Hamadan, Iran
City
Hamadan
Postal code
Approval date
2016-04-23, 1395/02/04
Ethics committee reference number
IR.UMSHA.REC.1395.37
Health conditions studied
1
Description of health condition studied
Episiotomy
ICD-10 code
O71.4
ICD-10 code description
First degree perineal laceration during delivery
Primary outcomes
1
Description
pain
Timepoint
10 days after delivery
Method of measurement
VAS ruler
2
Description
edema
Timepoint
10 days after delivery
Method of measurement
visual
3
Description
redness
Timepoint
10 days after delivery
Method of measurement
visual
4
Description
Ecchymosis
Timepoint
10 days after delivery
Method of measurement
visual
5
Description
discharge
Timepoint
10 days after delivery
Method of measurement
visual
6
Description
Approximation
Timepoint
10 days after delivery
Method of measurement
visual
7
Description
Sexual function
Timepoint
6 up to 12 weeks after delivery
Method of measurement
FSFI questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Patients in the intervention group: will be treated with aloe gel-Barij Essence product- twice daily for 10 days.
Category
Treatment - Drugs
2
Description
Group control: will be treated with routine treatment for 10 days.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh Hospital
Full name of responsible person
Nazanin Khademi
Street address
Taleghani street
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Ethics Committee of Hamadan University of Medical Sciences
Full name of responsible person
Dr. Bashirian Saeed
Street address
Fahmiheh Street, Hamadan University of Medical Sciences, Hamadan, Iran
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Ethics Committee of Hamadan 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
Hamadan University of Medical sciences
Full name of responsible person
Fatemeh Shobeiri
Position
Ph.D. in Masternal and Child Health
Other areas of specialty/work
Street address
No. 307, Fahmideh Street, Hamadan University of Medical sciences
City
Hamadan
Postal code
6516845977
Phone
+98 81 3827 6051
Fax
Email
shobeiri@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan University of Medical sciences
Full name of responsible person
Fatemeh Shobeiri
Position
Ph.D. in Masternal and Child Health
Other areas of specialty/work
Street address
No. 307, Fahmideh Street, Hamadan University of Medical sciences
City
Hamadan
Postal code
6516645977
Phone
+98 81 3827 6051
Fax
Email
shobeiri@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamadan University of Medical sciences
Full name of responsible person
Fatemeh Shobeiri
Position
Ph.D. in Masternal and Child Health
Other areas of specialty/work
Street address
No. 307, Fahmideh Street, Hamadan University of Medical sciences
City
Hamadan
Postal code
6516645977
Phone
+98 81 3827 6051
Fax
Email
shobeiri@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)