Comparison of the mean episiotomy pain score. Comparison of the mean of episiotomic repair score.
Design
This research is a randomized controlled trial, triple blind. With a sample of 70 people. Allocation of samples with an allocation ratio of 1: 1 will have a control group by random blocking method (blocks 4 and 6).
Settings and conduct
It is possible to conduct research in Al-Zahra Hospital in Tabriz. Eligible people and volunteers are randomly divided into two groups, one group will be given ginger extract ointment and the other group will be given placebo. Participants, researchers, data collectors and analysts are blind.
Participants/Inclusion and exclusion criteria
Primiparous women; lack of drug and psychotropic; age range 35-18 years old; live birth; single fetus; do not use any special medicine; failure to follow the special diet; no anemia during pregnancy; lack of early PPH; no history of prenatal vaginal examinations and manipulations; extent or large episiotomy (repair length 4-3 cm); willingness and possibility for the mother to visit Al-Zahra Hospital on days 5 and 15; no history of reconstructive surgery on the vagina and intercostals; lack of long-term rupture of the amniotic sac; do not use blood pressure medications; do not use topical lidocaine cream; do not use mopericin; do not use curettage in mothers.
Intervention groups
One group will be given ginger extract ointment and the other will be given placebo. The extent of wound healing by REEDA scale will be evaluated by the researcher before discharge and 1.5 ± 1.5 and 1 day after the intervention. The average severity of pain and discomfort at the site of the episiotomy incision in each group before discharge will be assessed by the VAS Pain Visual Assessment Scale.
Main outcome variables
Pain score and repair score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110922007618N9
Registration date:2020-08-14, 1399/05/24
Registration timing:registered_while_recruiting
Last update:2020-08-14, 1399/05/24
Update count:0
Registration date
2020-08-14, 1399/05/24
Registrant information
Name
Soheila Bani
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6770
Email address
banis@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-21, 1399/04/31
Expected recruitment end date
2021-01-19, 1399/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Zingiber officinale on healing and pain of episiotomy among primigravida women: A Randomized Controlled Trial
Public title
The effect of Zingiber officinale on healing and pain of episiotomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Primiparous women
The lack of drug and psychotropic
Age range 35-18 years
Birth of a live, single fetus
Do not use any special medicine(such as anti-inflammatory drugs other than acetaminophen and coagulation based on the patient's statements)
history of impaired wound healing disease, like systemic disease, cardiac, renal, pulmonary, coagulation disorders, immune deficiency, connective tissue disorders, diabetes,haemophilia
Failure to follow the special diet
No anemia during pregnancy
The lack of early PPH
No history of prenatal vaginal examinations and manipulations
extent or large episiotomy (repair length 4-3 cm)
Willingness and possibility for the mother to visit Al-Zahra Hospital on days 5 and 10
No history of reconstructive surgery on the vagina and intercostals (according to the woman)
Lack of long-term rupture of the amniotic sac (more than 18 hours)
Do not use blood pressure medications (mothers with high blood pressure and preeclampsia)
Do not use topical lidocaine cream
Do not use mopericin
Do not use curettage in mothers
Exclusion criteria:
Unwillingness to participate in the study
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible individuals and volunteers are randomly divided into blocks (4 and 6 blocks) with a 1: 1 allocation ratio randomly divided into two groups: one group of ginger extract ointment (intervention group) and the other group of placebo (Control group) will be given. The amount of pain is measured with a visual pain measuring instrument and the mean wound condition score is measured by the REEDA scale. The package will be numbered in order.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The placebo will be prepared in the form of sterile ointment and in closed tubes of both shape and color with drug packages. In addition to the person who determines the order of the individuals in the groups, the only person who will know the type of drug prescribed will be the researcher's assistant, and the participants, the researcher, the data collection and analyzer will not be informed.
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 St. - Tabriz University of Medical Sciences - Central Building No. 2 Floor 3 - Research Deputy
City
Tabriz
Province
East Azarbaijan
Postal code
5138947-977
Approval date
2020-06-30, 1399/04/10
Ethics committee reference number
IR.TBZMED.REC.1399.333
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
Episiotomy wound healing
Timepoint
Before intervention,12 hours after delivery and on days 5 and 15