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Comparison’s Effects of Honey and Olive Oil on Episiotomy repair in Deliverd Women in Besat Hospital Sanandaj,Year 2019

Protocol summary

Study aim
Comparison’s Effects of Honey and Olive Oil on Episiotomy repair in Deliverd Women
Design
A clinical trial with a control group, with parallel groups, blinded, is randomized
Settings and conduct
This study is performed on women with episiotomy in Besat Hospital in Sanandaj. Three groups have received placebo and two other groups of honey cream and olive oil. Participants will use creams in episiotomy for up to 10 nights per night. The researcher and participants do not know the type of creams and they are blind.
Participants/Inclusion and exclusion criteria
Inclination to participate in the study, gestational age of 42-37 weeks, normal delivery with mediolateral epididymis without rupture and tools of 3 to 5 cm in length, failure to use forceps and vaginosis during labor, live monocyte embryo with head appearance, infant weighing 4000 -2500 g; no use of drugs effective on wound healing by a mother; no history of wound healing disorder, no previous history of injury or previous surgery, and visible lesions in the perineum (genital warts, hemorrhoids), and constant constipation, no rupture of the sachet Water for more than 18 hours, absence of abnormal hemorrhage postpartum, non-manual placement of pairs, absence of perineal hematoma, defecation Ray re perineum after childbirth, neonatal hospitalization or absence of abnormalities
Intervention groups
This study was designed to compare the comparison of honey and olive oil on episiotomy recovery. Three groups received one placebo group and the other two received one cream of 30% honey and one worm, 30% olive oil. We measure the rate of recovery before the intervention with the reed's wound healing tool. Then we give creams to each of the three groups. After 5 and 10 days after the intervention, we examine the episiotomy site for recovery
Main outcome variables
The results of this study can be used to accelerate episiotomy and reduce pain.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190409043220N1
Registration date: 2019-04-25, 1398/02/05
Registration timing: prospective

Last update: 2019-04-25, 1398/02/05
Update count: 0
Registration date
2019-04-25, 1398/02/05
Registrant information
Name
Shahla Ghaderbasti
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 4622 0265
Email address
ghaderbastishahla@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-29, 1398/02/09
Expected recruitment end date
2019-10-01, 1398/07/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison’s Effects of Honey and Olive Oil on Episiotomy repair in Deliverd Women in Besat Hospital Sanandaj,Year 2019
Public title
Comparative study on the effect of honey and olive oil on episiotomy healing
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Inclination to Participate in the Study Gestational Age 37- 42 Weeks Normal Delivery with Mediolateral Episiotomy without Rupture and Tools of 3 to 5 Cm in Length Live Fetal Embryo with Head View A Baby Weighing 2500 - 4000 grams
Exclusion criteria:
Unwillingness to Participating in the Study Use of Forceps and Vacuume During Labor Use Drugs that Affect the Wound Healing by the Mother Cure for Diseases Affecting wound Healing Having a History of Previous Injury or Surgery and visible Lesions in the perineum (Genital Warts, Hemorrhoids) and Persistent Constipation Rupture of the Water Sac for more than 18 Hours Mother Abdominal Hemorrhage after childbirth Exit Manually Placenta The Presence of perineal Hematoma Retinal Remodeling after Delivery Neonatal Admission and Presence of Abnormalitie
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 165
Randomization (investigator's opinion)
Randomized
Randomization description
Participants with entry criteria are then randomly assigned to three groups using a sealed envelope. A simple randomization method, the individual randomization unit, is the tool for randomizing the packet.
Blinding (investigator's opinion)
Double blinded
Blinding description
The creams will be produced in 3 tubes with the same shape and color, and will be coded by the pharmacist, and the codes will be provided only to the supervisor, so that the researcher and the research units will be coded Will be aware.
Placebo
Used
Assignment
Parallel
Other design features
Honey and olive oil are used as cream with a purity of 30%.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Kurdistan University of Medical Sciences
Street address
Pasdaran street
City
Sanandaj
Province
Kurdistan
Postal code
666147 - 13446
Approval date
2019-03-17, 1397/12/26
Ethics committee reference number
IR.MUK.REC.1397.388

Health conditions studied

1

Description of health condition studied
Episiotomy repair
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Episiotomy Repaire
Timepoint
The first 12 hours before the intervention and the 5th and 10th day after the intervention
Method of measurement
Reeda Scale

2

Description
Episiotomy site pain
Timepoint
The first 12 hours after delivery and before the intervention, on days 5 and 10 after delivery
Method of measurement
Visual Analogue Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:The first intervention group is 30 gr. Of honey with a purity of 30%, of which 55 are in this group. Cream is made by the Shafa herbal medicine company in Sanandaj. Intervention in this group starts at 12 hours postpartum. Each person takes one centimeter of worms every 12 hours in the episiotomy for up to 10 days.
Category
Treatment - Drugs

2

Description
Intervention group:The second intervention group is 30 grams of olive oil with a purity of 30%, of which 55 are in this group. Cream is made by the herbal healing plant in Sanandaj. Intervention in this group starts at 12 hours postpartum. Each person takes one centimeter of worms every 12 hours in the episiotomy for up to 10 days.
Category
Treatment - Drugs

3

Description
Control group: The group receives a placebo cream in the same color and shape as the two groups of creams, of which 55 are in this group. Cream is made by the Shafa Herbal Drug Company in Sanandaj. Intervention in this group starts at 12 hours postpartum. Each person takes one centimeter of worms every 12 hours in the episiotomy for up to 10 days.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Besat hospital
Full name of responsible person
Shahla Ghaderbasti
Street address
Keshavarz Street
City
sanandaj
Province
Kurdistan
Postal code
6648456485
Phone
+98 87 3328 5912
Email
shahlaghaderbasti2016@gmail.com
Web page address
http://www.muk.ac.ir/Muk/Hospitals/Besat/ContactUs.aspx

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Roonak Shahooie
Street address
Pasdaran Street
City
sanandaj
Province
Kurdistan
Postal code
6654564555
Phone
+98 87 3323 2930
Email
shahlaghaderbasti2016@gmail.com
Web page address
http://www.muk.ac.ir/Muk/Hospitals/Besat/ContactUs.aspx
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sanandaj University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Khadijeh Seyed Kaboli
Position
Academic staff
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Pasdaran Sreet
City
Sanandaj
Province
Kurdistan
Postal code
666147 - 13446
Phone
+98 87 3366 4664
Fax
+98 87 3366 4643
Email
Payam_parya@yahoo.com
Web page address
http://muk.ac.ir/Muk.aspx

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Khadijeh Seyed Kaboli
Position
Academic staff
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Pasdaran Sreet
City
Sanandaj
Province
Kurdistan
Postal code
666147 - 13446
Phone
+98 87 3366 4664
Fax
+98 87 3366 4643
Email
Payam_parya@yahoo.com
Web page address
http://muk.ac.ir/Muk.aspx

Person responsible for updating data

Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Khadijeh Seyed Kaboli
Position
Academic staff
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Pasdaran Sreet
City
Sanandaj
Province
Kurdistan
Postal code
666147 - 13446
Phone
+98 87 3366 4664
Fax
+98 87 3366 4643
Email
Payam_parya@yahoo.com
Web page address
http://muk.ac.ir/Muk.aspx

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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