Phytochemical investigations on myrtle and chamomlie essential oils and their effects on episiotomy
Design
Randomized clinical trial with two intervention groups, parallel groups, double blind, 80 patients
Settings and conduct
The drug packages are similar and given to women by other person. This person does not inform about the package contents.This study is conducted in Fatemieh hospital of Hamadan city. Therefore, neither the researcher nor the women know the contents of the package and double blinding is performed.
Participants/Inclusion and exclusion criteria
Criteria inclusion: Pregnancy age 37 weeks and higher at delivery time, maternal age 18-35 years, medioteral incision and 2nd degree of episiotomy, not having physical diseases, not having pregnancy complications, not having condyloma or herpes lesions in the perineum Primigravida
Criteria exclusion: Infection during treatment, irregular use of the drug, refuse from continuing to participate in study
Intervention groups
Intervention groups:
Chamomile Ointment will be prescribed twice in a day for ten days. This drug will be produced by Hamadan University of Medical Sciences.
Myrtle Ointment will be prescribed twice in a day for ten days. This drug will be produced by Hamadan University of Medical Sciences.
Main outcome variables
Wound healing; pain severity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180707040370N7
Registration date:2020-06-15, 1399/03/26
Registration timing:prospective
Last update:2020-06-15, 1399/03/26
Update count:1
Registration date
2020-06-15, 1399/03/26
Registrant information
Name
Ensiyeh Jenabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0496
Email address
e.jenabi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2020-10-22, 1399/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Phytochemical investigations on myrtle and chamomlie essential oils and their effects on episiotomy: double blinded clinical trial
Public title
Phytochemical investigations on myrtle and chamomlie essential oils and their effects on episiotomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Gestational age 37 weeks and higher at delivery time
Maternal age 18-35 years
Mediolateral incision and episiotomy degree 2
No physical diseases
No pregnancy complications
No condyloma or herpes lesions in the perineum
Primigravida
Exclusion criteria:
Infection during treatment
irregular use of the drug
refuse from continuing to participate in study
Age
From 18 years old to 35 years old
Gender
Female
Phase
2
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
The Excel computer program by ((Choose (randbetween(1;2) command, Randomly write the number 1 or 2 in front of each of these 80 people so that the people are evenly distributed. In this study, the number one in the group receiving chamomile and the number two in the group receiving Mort will be assigned.
Blinding (investigator's opinion)
Double blinded
Blinding description
The drug packages are similar and are given to women by other person. This person does not inform about the package contents.Therefore, neither the researcher nor the women knows the contents of the package and double blinding will be performed.
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
Hamadan University of Medical Sciences, Fahmiheh Street, Hamadan
City
همدان
Province
Hamadan
Postal code
6517838678
Approval date
2020-05-23, 1399/03/03
Ethics committee reference number
IR.UMSHA.REC.1399.217
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
Pain severity
Timepoint
Pre intervention, 6 hour and 5 and 10 days after intervention
Method of measurement
Visual analogue scale (VAS)
2
Description
healing wound
Timepoint
Pre intervention, 6 hour and 5 and 10 days after intervention