Protocol summary
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Study aim
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Phytochemical investigations on myrtle and chamomlie essential oils and their effects on episiotomy
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Design
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Randomized clinical trial with two intervention groups, parallel groups, double blind, 120 patients
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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Inclusion Criteria: Pregnancy age 37 weeks and higher at delivery time, maternal age 18-35 years, mediolateral incision and 2nd degree of episiotomy, not having physical diseases, not having pregnancy complications, not having 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
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Intervention groups
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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.
Placebo Ointment will be prescribed twice in a day for ten days. This drug will be produced by Hamadan University of Medical Sciences.
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Main outcome variables
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Wound healing; pain severity
General information
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Reason for update
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Adding of the placebo group
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180707040370N7
Registration date:
2020-06-15, 1399/03/26
Registration timing:
prospective
Last update:
2024-01-27, 1402/11/07
Update count:
1
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Registration date
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2020-06-15, 1399/03/26
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-06-21, 1399/04/01
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Expected recruitment end date
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2020-10-22, 1399/08/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Phytochemical investigations on myrtle and chamomlie essential oils and their effects on episiotomy: double blinded clinical trial
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Public title
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Phytochemical investigations on myrtle and chamomlie essential oils and their effects on episiotomy
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 35 years old
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Gender
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Female
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Phase
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2
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Groups that have been masked
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Sample size
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Target sample size:
120
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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The Excel computer program by ((Choose (randbetween(1;2;3) command, Randomly write the number 1 or 2 or 3 in front of each of these 120 people so that the people are evenly distributed. In this study, the number one in the group receiving chamomile, the number two in the group receiving Mort, and the number three in the group receiving placebo will be assigned.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-05-23, 1399/03/03
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Ethics committee reference number
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IR.UMSHA.REC.1399.217
Health conditions studied
1
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Description of health condition studied
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Episiotomy
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ICD-10 code
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O90.1
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ICD-10 code description
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Disruption of perineal obstetric wound
Primary outcomes
1
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Description
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Pain severity
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Timepoint
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Pre intervention, 6 hour and 5 and 10 days after intervention
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Method of measurement
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Visual analogue scale (VAS)
2
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Description
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Healing wound
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Timepoint
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Pre intervention, 6 hour and 5 and 10 days after intervention
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Method of measurement
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Episiotomy wound healing rate scale, REEDA (Redness, Edema, Ecchymosis, Discharge, Approximation)
Intervention groups
1
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Description
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Chamomile Ointment will be prescribed twice in a day for ten days. This drug will be produced by Hamadan University of Medical Sciences.
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Category
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Treatment - Drugs
2
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Description
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Chamomile Ointment will be prescribed twice in a day for ten days. This drug will be produced by Hamadan University of Medical Sciences.
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Category
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Treatment - Drugs
3
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Description
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Control group: Placebo Ointment will be prescribed twice in a day for ten days. This drug will be produced by Hamadan University of Medical Sciences.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Hamedan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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A portion of the information, such as information on the main outcome or the like, can be shared.
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When the data will become available and for how long
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6 months after publishing the results
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To whom data/document is available
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Researchers working in academia
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Under which criteria data/document could be used
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Data analysis is permitted with the author's permission.
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From where data/document is obtainable
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Hamadan University of Medical Sciences
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What processes are involved for a request to access data/document
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6 months after of paper publish
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Comments
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