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Effect of Cinnamon Extract on Reducing Perineal Pain Following Episiotomy

Protocol summary

Summary
This study aimed to determine the effect of cinnamon extract to reduce the pain of episiotomy. Primiparous woman, first degree episiotomy wound with a length of 3-4 cm and a depth of up to 3 mm, singleton term pregnancy, 18 to 35 years old, No underlying medical condition and absence of chemotherapy and drug allergy are the Inclusion criteria. Occurring Hematomas, Infection, need for neonatal resuscitation, development of episiotomy, abnormal bleeding after childbirth, perineal re-manipulation, prolonged rupture of membranes, prolonged childbirth, The need to use instrument for delivery and grade 3 or 4 Perineal laceration are the Exclusion criteria. The sample size is 68 healthy Primiparous women with a normal delivery with episiotomy admitted to Asali hospital of Khorramabad In 2014. Patients will be matched with each for age, length of second stage of labor, the length of incision and pain severity. To assess the severity of pain, the visual graded scale will be used. Pain severity immediately will be recorded after entering maternal care room, then the intervention group will receive a specific dosage of cinnamon extract (3.5%) And will be applied at the site of episiotomy then, in 1 and 4 hours after use also will be recorded. Residual extract and placebo given to them to use it if had a pain and the patients will be visited on the tenth day.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015012420734N2
Registration date: 2015-06-03, 1394/03/13
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-06-03, 1394/03/13
Registrant information
Name
Younes Azizpourfard
Name of organization / entity
Lorestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 919 038 3060
Email address
dr.azizpourfard@lums.ac.ir
Recruitment status
Recruitment complete
Funding source
Lorestan University of Medical Scienses
Expected recruitment start date
2014-03-20, 1392/12/29
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Cinnamon Extract on Reducing Perineal Pain Following Episiotomy
Public title
The Effect of Cinnamon Extract on Reducing Perineal Pain Following Episiotomy in Primiparous Women in Khorramabad Asali Hospital in 2014
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Primiparous woman; Educated; Iranian; body mass index between 19/8-25 kg/m2 ;first degree episiotomy wound with a length of 3-4 cm and a depth of up to 3 mm; singleton term(37-42 weeks) pregnancy; 18 to 35 years old; No underlying medical condition(Cardiovascular, hepatic, renal, diabetes, coagulation disorders, anemia, constant constipation and hemorrhoids) ; absence of chemotherapy and allergy to Herbal Medicines; Not taking anticoagulant drugs; antidepressants; anticonvulsants; antibiotics; immunosuppressive drugs; alcohol; smoking and opiate materials; No history of active skin disease (allergic disorder, symptomatic vaginitis, Skin ulcer or sensitivity at the site) ; anterior position view of the fetal head for episiotomy on the gynecologic bed. Exclusion criteria: Occurring Hematomas; Infection; need for neonatal resuscitation; development of episiotomy; abnormal bleeding after childbirth; perineal re-manipulation; Prolonged rupture of membranes (more than 18 hours) ; the first stage of labor (over 14 hours) ; second phase of pregnancy (more than 2 hours); the third stage of labor (more than 1 hour); The need to use instrument for delivery; grade 3 or 4 Perineal laceration.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 68
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Lorestan University of Medical Sciences
Street address
3th km to khgoramabad-boroujerd road
City
khgoramabad
Postal code
Approval date
2014-03-23, 1393/01/03
Ethics committee reference number
LUMS.REC.1394,8

Health conditions studied

1

Description of health condition studied
Perineal laceration during delivery
ICD-10 code
O70
ICD-10 code description
Perineal laceration during delivery Incl.: episiotomy extended by laceration

Primary outcomes

1

Description
Improvement of episiotomy site pain
Timepoint
Immediately after surgery, 0 and 1 and 4 hours after episiotomy
Method of measurement
Visual graded scale

Secondary outcomes

1

Description
Adverse reactions (allergy)
Timepoint
At one and four اhours after the surgery, the tenth visit day, any unpredictable time
Method of measurement
By examination and regular visits and record patient pain complaint

Intervention groups

1

Description
Intervention group will receive a specific dosage of cinnamon extract (3.5%) And will be applied at the site of episiotomy then, in 1 and 4 hours after use also will be used. Residual extract will be given to them to use it if had a pain and the patients will be visited on the tenth day.
Category
Treatment - Drugs

2

Description
Control group will receive a specific dosage of placebo and will be applied at the site of episiotomy then, in 1 and 4 hours after use also will be used. Residual placebo will be given to them to use it if had a pain and the patients will be visited on the tenth day.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Asali Hospital of Khorramabad
Full name of responsible person
Masoume Ghafarzadeh
Street address
City
Khorramabad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
Dr. varzi
Street address
3th km to Khorramabad-Boroujerd road
City
Khorramabad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Lorestan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
lorestan university of Medical science
Full name of responsible person
Masoume Ghafarzadeh
Position
Professor
Other areas of specialty/work
Street address
Qhaziabad, Asali Hospital
City
Khorramabad
Postal code
Iran
Phone
+98 66 3343 0637
Fax
Email
dr.ghafarzade@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
Masoume Ghafarzadeh
Position
Proffessor
Other areas of specialty/work
Street address
Ghaziabad, Asali Hospital
City
Khorramabad
Postal code
Phone
+66 33 430 637
Fax
Email
dr.ghafarzade@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
Younes Azizpourfard
Position
Medical Doctor
Other areas of specialty/work
Street address
22 Bahman street, Shohada Ashayer Hospital
City
Khorramabad
Postal code
Phone
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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