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The effect of chamomilla cream on wound healing and pain of episiotomy in Primiparous women

Protocol summary

Summary
Introduction: episiotomy Cutting perineal muscles, with the aim of accelerating the completion of the second phase is to improve the outcome for mother and baby. Drugs with anti-inflammatory effects, antibacterial and antioxidant activity, candidates are suitable for wound healing. Chamomile has all of the above. This study investigated the effects of chamomile cream on wound healing episiotomy was performed. Methods: This study was triple blind clinical trial on 106 women admitted to hospital Omolbanin Mashhad, Iran. Nulliparous women aged 18-35 years, with single fetal cephalic, no history of disease impaired wound healing and not using drugs effecting on wound healing, were selected easy method and then using a randomized block design with two intervention groups (chamomile cream) and control (placebo cream) groups. The labor process control and information related to this process were recorded. If there were a disruption in the progress of labor, delivery devices (vacuum, forceps), have extended the length of the incision or there was tear except episiotomy tear episiotomy the research unit would excluded. Units of study Amount by a finger of prescribed cream (chamomile or placebo) twice daily for 10 days, placed on the sutures. Perineal repair Control Form (Reeda) on days 1,7,10 and 14 after delivery was completed. And the Short Form McGill Pain immediately before the intervention and 1,7,10 and 14 days after the delivery was completed by the researcher.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013051413336N1
Registration date: 2013-12-25, 1392/10/04
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-12-25, 1392/10/04
Registrant information
Name
Maryam Aradmehr
Name of organization / entity
School of Nursing and Midwifery Mashhad
Country
Iran (Islamic Republic of)
Phone
+98 51 1843 3363
Email address
pouravazm901@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2013-07-23, 1392/05/01
Expected recruitment end date
2013-10-26, 1392/08/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of chamomilla cream on wound healing and pain of episiotomy in Primiparous women
Public title
The effect of chamomilla cream on wound healing and pain of episiotomy in Primiparous women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: nulliparous women aged 18-35 years old living in the city of Mashhad, Iran; at least having the ability to read and write; living with his wife's; body mass index ranging from 19/8-30; non-smoking and no drug dependence; no history of disease impaired wound healing; not using drugs effecting on wound healing; single fetal cephalic; lack of symptomatic infections of the vagina and vulva (the infectious discharge, itching, burning); low blood, anal lesions; vulva and perineum on admission; and rupture of the fetal sac up to 12 hours before the start of pains; lack of stricture restriction pelvic; embryos is vital; the lack of apparent anomalies in the newborn. No rectocel, cystocele severe (grade 2 or higher), wall or mass in the vaginal; no history of obstetric complications, use of acetaminophen suppository in 6 hours before delivery; no history of vaginal reconstructive surgery on the Vagina and urethra Exclusion criteria: there interfere with the progress of labor; prolonged second stage of labor longer than 2 hours; delivery devices (vacuum, forceps); delivered via cesarean section; extend the length of the incision or there tear except episiotomy tear; infant hospitalization in the NICU; abnormal vaginal bleeding; shoulder dystocia (leading to the maneuvers other than Robert Mack); manual removal of placenta; hematoma; having intercourse to the end of the study (15 days postpartum); curettage procedure the first 24 hours after birth; the third stage of labor longer than 30 minutes; the occurrence of an adverse event at 15 days postpartum; no need for episiotomy; not use the cream on a regular; puerperal fever; complications resulting from the use of chamomile cream.
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 106
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences
Street address
khorasan razave
City
Mashhad
Postal code
Approval date
2013-06-22, 1392/04/01
Ethics committee reference number
911324

Health conditions studied

1

Description of health condition studied
wound healing of episiotomy , pain of episiotomy
ICD-10 code
O90.1
ICD-10 code description
Disruption of perineal obstetric wound

Primary outcomes

1

Description
Pain of episiotomy
Timepoint
Immediately before the intervention to 2 weeks after intervention
Method of measurement
McGill Pain Questionnaire short

2

Description
Wound healing of episiotomy
Timepoint
First Day of episiotomy repair to 14 days
Method of measurement
Scale reeda

Secondary outcomes

1

Description
The rate of pain episiotomy
Timepoint
Immediately prior to the 2-week after the start of the intervention intervention.
Method of measurement
Questionnaire McGill Pain short

2

Description
The rate of wound healing of episiotomy
Timepoint
First Day of episiotomy repair to 14 days
Method of measurement
Scale reeda

Intervention groups

1

Description
In the intervention group, chamomile cream 1/3 percent of the combined value is Cold Cream with Chamomile has been used. Units of study Chamomile cream the size of a finger is placed on the sutures so that the wound is completely covered and do the daily double (each 12h) up ten days.
Category
Treatment - Drugs

2

Description
In the control group of placebo cream containing simple base cream (Cold Cream) are used. Units of study placebo cream the size of a finger is placed on the sutures so that the wound is completely covered and do the daily double (each 12h) up ten days.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Specialized Women's Hospital, Mashhad Omolbanin (SA), Mashhad University of Medical Sciences
Full name of responsible person
Azhari sedigheh, MS Nursing, Midwifery Training
Street address
Khorasan Razavi, Mashhad, Intersection Zarineh, Omolbanin Women's Hospital (SA)
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Council of Mashhad University of Medical Sciences
Full name of responsible person
Dr.tafaghodi
Street address
Khorasan Razavi, Mashhad University Avenue, Building Qureshi
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Council of Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Maryam Aradmehr
Position
MSc of Midwifery
Other areas of specialty/work
Street address
Khorasan Razavi, Mashhad, intersection,Doktora Intersection , School of Nursing and Midwifery, Mashhad
City
Mashhad
Postal code
Phone
Fax
Email
maryam.aradmehr@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Nursing and Midwifery, Mashhad
Full name of responsible person
Azhari sedigheh
Position
Master of Midwifery, Faculty of Nursing and Midwifery
Other areas of specialty/work
Street address
Khorasan Razavi, Mashhad, intersection Doctora, School of Nursing and Midwifery, Mashhad
City
Mashhad
Postal code
Phone
+98 51 1859 1511
Fax
Email
azharis@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Maryam Aradmehr
Position
MSc of Midwifery
Other areas of specialty/work
Street address
Khorasan Razavi, Mashhad, intersection,Doktora Intersection , School of Nursing and Midwifery,
City
Mashhad
Postal code
Phone
Fax
Email
maryam.aradmehr@yahoo.com
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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