Protocol summary
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Study aim
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Determination Of Investigating The Effect Of Olea Ointment On Cesarean Incision Local Pain And Healing In Mothers After Cesarian Section
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Design
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Randomised,Controlled, Parallel Group Trial, Double Blinded Design Of 92 Patients. Randomisation Was Done By Online Randomization Service Point Sealed Envelope Ltd2019
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Settings and conduct
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Eligible Mothers Are In Two Groups Of Olea And Placebo Ointment And Receive Olea And Placebo Ointment Every 12 Hours And The Amount Of Pain And Repair Of Their Abdominal Incision Will Be Measured With Pain And Rida Instruments.
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Participants/Inclusion and exclusion criteria
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Willingness And Satisfaction To Enter The Study, Cesarean Delivery In Al-Zahra Educational-Medical Center In Rasht and Shahid Hosseinpour Langroud Hospital, Primary And Multi-par Mothers With a History Of Two Cesarean Sections, Gestational Age 37 to 42 Weeks Depending On The Ultrasound Or The First Day of The Last Period, Abdominal Incision Of Transverse Type, Maximum Rupture Time Of Membran Less Than 12 Hours, Minimum Literacy, Have a phone number, Absence of systemic diseases including Diabetes And Cardiovascular Disease, Blood Pressure Coagulation Disorders During Or Before Pregnancy, No Postpartum Hemorrhage, No Blood Transfusion In Surgery, Do Not Take Certain Medications That Increase The Risk Of Postpartum Infection.
Misuse Of Olea Ointment By Research Units, Allergy To Ointment During the Study, Concomitant Use Of Other Ointments Or Topical Medications
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Intervention groups
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The Intervention Group Applied Olea Ointment To The Cesarean Section Every 12 hours. After At Least Two Minutes, Covered The Wound With A Sterile Gauze And Bandaged It. The First Intervention Will Be Performed 24 Hours After The Operation.
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Main outcome variables
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Rate Of Local Pain, Abdominal Incision Repair
General information
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Reason for update
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Added research environment
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Acronym
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ندارد
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IRCT registration information
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IRCT registration number:
IRCT20170203032374N3
Registration date:
2021-10-10, 1400/07/18
Registration timing:
prospective
Last update:
2022-02-05, 1400/11/16
Update count:
1
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Registration date
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2021-10-10, 1400/07/18
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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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2021-10-23, 1400/08/01
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Expected recruitment end date
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2022-02-20, 1400/12/01
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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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Investigating The Effect Of Olea Ointment On Cesarean Incision Local Pain And Healing In Mothers After Cesarian Cection
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Public title
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Investigating The Effect Of Olea Ointment On Cesarean Incision Local Pain And Healing In Mothers After Cesarian Cection
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Willingness And Satisfaction To Enter The Study
Cesarean Delivery In Al-Zahra Educational-Medical Center In Rasht and Langroud Shahid Hosseinpour Hospital
Primary And Multi-par Mothers With A History Of Two Cesarean Sections
Gestational Age 37 to 42 Weeks Depending On The Ultrasound Or The First Day Of The Last Period
Abdominal Incision Of Transverse Type
Maximum Rupture Time Of Membran Less Than 12 Hours
Minimum Literacy, Have A phone number To follow
Absence Of Systemic Diseases Including Diabetes And Cardiovascular Disease
Blood Pressure Coagulation Disorders During Or Before Pregnancy
No Postpartum Hemorrhage
No Blood Transfusion In Surgery
Do Not Take Certain Medications That Increase The Risk Of Postpartum Infection
Exclusion criteria:
Misuse Of Olea Ointment By Research Units
Allergy To Ointment During the Study
Concomitant Use Of Other Ointments Or Topical Medications
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Age
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No age limit
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
92
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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In This Study, By The Number Of Sample Volumes Required, Block Randomization With 4 And 6 Block Sizes Will Be Used To Randomize Sample In The Two Groups Of Olea Ointment And Placebo.
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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 Present Study Will Be a Double-Blind, Randomized, Placebo-Controlled Clinical Trial. The Researcher And Research Units Will Be Unaware Of The Content Of Ointments Used. A Person Outside The Group Will Know The Content Of Ointments Used And Will Classify The Ointments According To A And B, Which Represent (Intervention And Placebo Group) And According To The Pre-Determined Random List, It Will Be Labeled On Ointments A And B And Packed In A Non-Transparent Envelope In The Order And Sequence, And Will Be Provided To The Researcher Inside The Box. Then, If They Are Satisfied, They Will Be Selected To Participate In The Study In An Accessible And Gradual Manner, And All Eligible Individuals Will Be Divided Into Two Groups Of Olea Ointment And Placebo According To The Specified Sequence, Using A Block Randomization Method With 4 And 6 Block Sizes. The Contents Of The Ointments Will Be Provided To The Research Units In Clean Containers Of One Shape and One Color And Free Of Charge.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Not
Ethics committees
1
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Ethics committee
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Approval date
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2021-09-29, 1400/07/07
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Ethics committee reference number
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IR.GUMS.REC.1400.306
Health conditions studied
1
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Description of health condition studied
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The Extent of Local Pain and Repair of Cesarean Section in Referring Mothers
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ICD-10 code
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090.0
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ICD-10 code description
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• O85-O92 Complications Predominantly Related To the PuerperiumO86.0 Infection of Obstetric Surgical Wound. Infected Caesarean Section Wound Followimg Delivery
Primary outcomes
1
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Description
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The Extent of Local Pain and Repair of Cesarean Section in The Referring Mothers
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Timepoint
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The Severity of Pain Before With the Visual Scale of Pain Ruler and The Condition of Abdominal Incision Improvement Are Also Evaluated And Recorded By The Researcher Using The Reeda Scale Before The Intervention, 24 Hours After The First Intervention And On Days 5 And 10 After Cesarean Section.
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Method of measurement
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Visual Analogue Scale (VAS) and Reeda
Intervention groups
1
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Description
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Intervention group: The Intervention Group Will Be The Group Receiving Olea Ointment. First, The Researcher Will Be Taught How To Use The Ointment For The First Time, And Then The Samples Of The Intervention Group Will Be Asked To Place A Layer Of Olea Ointment On The Abdominal Cesarean Section Every 12 Hours And For At Least Two Minutes. Remain On The Skin And Then Cover The Wound With Sterile Gauze And Bandage. The First Intervention Will Be Performed By The Researcher 24 Hours After The Operation And The Next Interventions Will Be Performed By The Researcher During The Hospital Stay and After Discharging The Samples From The Hospital. It Will Be Done By The Person Himself
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Category
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Treatment - Drugs
2
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Description
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Control group: The Placebo Group Will Receive A Placebo Ointment. First, The Researcher Is Taught How To Use The Ointment For The First Time, And Then The Samples Of The Intervention Group Are Asked To Put A Layer Of Ointment On The Abdominal Cesarean Section Every 12 Hours And On The Cesarean Section For At Least Two Minutes. The Skin Remains And Then The Wound Is Covered With Sterile Gauze AndThe First Intervention Will Be Performed By The Researcher 24 Hours After The Operation And The Next Interventions Will Be Performed By The Researcher During The Hospital Stay And After Discharge Of The Samples From The Hospital By The Person Will Do It Himself.
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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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No
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Title of funding source
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Vice Chancellor for Research and Technology of Guilan 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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Private
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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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Persons
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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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is 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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Undecided - It is not yet known if there will be 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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The results of the data and the main consequences will be shared after the study in format of knowledge translation and exchange report to the university, presentation of reports in domestic or foreign conferences and seminars and publication of article in domestic or foreign scientific-research journals
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When the data will become available and for how long
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It is possible to access the study results after the defense and scientific confirmation of the dissertation In a 3 months period
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To whom data/document is available
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if requested, results will be available to other academic investigators and Vice Chancellor for Research and Technology of Guilan University of Medical Sciences
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Under which criteria data/document could be used
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The collected data is confidential and will not be disclosed to other persons without the awareness of the Vice Chancellor for Research and Technology of the relevant university
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From where data/document is obtainable
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To receive the documentation, send the email for update manager
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What processes are involved for a request to access data/document
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After the necessary checks, the desired documentary will be sent by email within one month period
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Comments
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