This double-blind RCT will be conducted to determine and compare the effect of Olea ointment and Lidocaine gel 2% on pain and episiotomy wound healing in a sample of 123 primiparous women attending al-Zahra hospital, Rasht, Iran in 2017-2018. The samples will be firstly selected purposefully and then randomly allocated in one of the 3 groups: Olea (first intervention group), Lidocaine (second intervention group) and Normal Saline serum (routine care, control group). Inclusion criteria: Primiparous; 18-35y; voluntary participation; Live term pregnancy; single fetus; Cephalic presentation; Mediolateral episiotomy; Baby weight 2500-4000 g; Lack of PROM > 18 h; and maternal BMI = 19.8-30. Exclusion criteria: Unwillingness to participate; Inappropriate use of medications > 2 nights; Allergy to the medications; and failure to go to the hospital on days 5 and 10 postpartum. Four hours after episiotomy, the first intervention will be applied by the researcher. After that, the intervention groups will be asked to put some Olea ointment and Lidocaine gel on the sutures at bedtime and use a sanitary pad after 1-2 minutes, and then repeat it every 24 h till 10th day after childbirth. The intervention groups will also use routine care. The third group will only use Normal Saline twice a day. Pain and episiotomy wound healing will be investigated with Pain Visual Scale and REEDA scale respectively before intervention, 2h and 24 h after the first intervention, 5 and 10 days postpartum by the researcher. Data using descriptive and inferential statistics under SPSS 19 will be analyzed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017020332374N1
Registration date:2017-10-05, 1396/07/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-10-05, 1396/07/13
Registrant information
Name
Fatemeh Jafarzadeh-Kenarsari
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 3373 3606
Email address
jafarzadeh@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research and Technology of Guilan University of Medical Sciences
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-04-21, 1397/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Olea ointment and 2 % Lidocaine Gel on pain relieving and episiotomy wound healing in primiparous women
Public title
The effect of Olea ointment and Lidocaine Gel 2 % on pain relieving and episiotomy wound healing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterias: Iranian patients; Primiparous; 18-35 years old; Literate; Volunteer; Term pregnancy with single fetus; Cephalic presentation; Mediolateral episiotomy; Newborn weight about 2500-4000 g; Absence of diseases affecting wound healing; Lack of PROM longer than 18 hours; The maternal BMI range between 19/8 and 30.
Exclusion criteria: Unwillingness to continue to participate in the study; The use of other effective drugs for wound healing during the study; Inappropriate use of medications (more than two nights); Allergy to the Olea ointment or Lidocaine gel 2%; Failure to go to hospital on days 5 and 10 after delivery; Having a sexual relationship in the first five days after childbirth.
Age
From 18 years old to 35 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
123
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
Guilan University of Medical Sciences
Street address
Guilan University of Medical Sciences-Rasht-Iran
City
Rasht
Postal code
98
Approval date
2017-08-05, 1396/05/14
Ethics committee reference number
IR.GUMS.REC.1396.191
Health conditions studied
1
Description of health condition studied
Episiotomy
ICD-10 code
O70.0, O70
ICD-10 code description
First degree perineal laceration during delivery,Second degree perineal laceration during delivery
Primary outcomes
1
Description
Severity of episiotomy pain
Timepoint
Before intervention; 2 h and 24 h after first intervention; 5th and 10th days of postpartum
Method of measurement
pain visual scale
2
Description
Episiotomy wound healing
Timepoint
Before intervention; 2 h and 24 h after first intervention; 5th and 10th days of postpartum
Method of measurement
REEDA Scale
Secondary outcomes
1
Description
Drug side effects
Timepoint
2h after first intervention; 24h after first intervention; 5th and 10th days of postpartum
Method of measurement
Drug side effects Form
2
Description
Maternal health condition
Timepoint
2h after first intervention; 24h after first intervention; 5th and 10th days of postpartum
Method of measurement
Maternal health condition Form
3
Description
Used analgesic
Timepoint
2h after first intervention; 24h after first intervention; 5th and 10th days of postpartum
Method of measurement
Used analgesic Form
Intervention groups
1
Description
Olea Ointment (First intervention group): This ointment is made in Farateb Company, Yazd,Iran. Its ingredients are:10 g Olive Oil, 10g Sesame, and 10 g honey.This ointment is available in 30 gram tubes.Four hours after episiotomy, the first intervention will be applied by the researcher. After that, the intervention groups will be asked to put some Olea ointment on the sutures at bedtime and use a sanitary pad after 1-2 minutes, and then repeat it every 24 h till 10th day after childbirth.
Category
Treatment - Drugs
2
Description
Lidocaine gel 2% (Second intervention Group) is made in Razi Drug Company, Tehran, Iran. Four hours after episiotomy, the first intervention will be applied by the researcher. After that, the intervention groups will be asked to put some Lidocaine gel 2% on the sutures at bedtime and use a sanitary pad after 1-2 minutes, and then repeat it every 24 h till 10th day after childbirth. Both intervention groups will also use routine care (use of Normal Saline twice a day).
Category
Treatment - Drugs
3
Description
Normal Saline 0.9 % (Control Group), non-injectable, made in Parsdaro Co, Tehran,Iran. The Control group will only use Normal Saline twice a day till 10th day after childbirth.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Dr.Fatemeh Jafarzadeh-Kenarsari
Street address
Rasht-Guilan-Iran
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Deputy of Research and Technology
Street address
Infront of 17 Sharivar Hospital-Rasht-Guilan-Iran
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Guilan 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
GUILAN UNIVERSITY OF MEDICAL SCIENCES
Full name of responsible person
Dr. FATEMEH JAFARZADEH-KENARSARI
Position
Assistant professor
Other areas of specialty/work
Street address
East Guilan Nursing and Midwifery -Langroud-Guilan-Iran
City
Langroud
Postal code
98
Phone
+98 13 4256 5058
Fax
+98 13 4256 5051
Email
f.kenarsari2013@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr. Fatemeh Jafarzadeh-Kenarsari
Position
Assistant professor/ PhD in Reproductive Health
Other areas of specialty/work
Street address
Rasht-Guilan-Iran
City
Rasht
Postal code
98
Phone
+98 13 4256 5058
Fax
Email
f.kenarsari2013@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr.Fatemeh Jafarzadeh-Kenarsari
Position
PhD in Reproductive Health/ Assistant professor
Other areas of specialty/work
Street address
Rasht-Guilan-Iran
City
Rasht
Postal code
98
Phone
+98 13 4256 5058
Fax
Email
f.kenarsari2013@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)