The aim of this study is to determine the effect of combination of Chamomile and Calendula oficinalis on healing and pain intensity of episiotomy in primiparous women. This randomized clinical trial will be done on 99 primiparous women admitting in Akbarabadi hospital. Incluson criteria contain: being primiparous women with age range 18-35 years; gestational age 37-42 weeks; single pregnancy; cephalic presentation; ability to read and write; living with his wife's; insensitivity to special herbal drugs in past; non-smoking and no drug dependence; no history of disease impaired wound healing; Lack PROM more than 18 hours; absence of reconstructive surgery on the vagina and perineum; No rectocel, cystocele severe (grade 2 or higher), wall or mass in the vagina; mediolateral episiotomy without rupture and spread with same amount of Lidocaine; lack of volvo and vaginal inflammation at the beginning of research; body mass index less than 30; and Exclusion criteria contain: there interfere with the progress of labor; prolonged second stage of labor longer than 2 hours; extend the length of the incision or there tear except episiotomy tear; 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 (10 days postpartum); curettage procedure the first 24 hours after birth; not use the ointment on a regular; puerperal fever; an infection of episiotomy; need to re-stitch the episiotomy. Eligible women will be randomly divided into three Intervention, Placebo and control groups. the Intervention group will use Combined ointment, and the placebo group will use Placebo ointment on episiotomy incision every 8 hours. Control group will not use anything on episiotomy incision. Our scale to check the wound healing is REEDA table and Our scale to check the pain reliving is VAS rule. We check the wound healing and pain before intervention (4 hours after delivery) then1 day, 5 day and 10 day after starting intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015102624712N1
Registration date:2015-12-11, 1394/09/20
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-12-11, 1394/09/20
Registrant information
Name
Homa Sadeghi Aval Shahr
Name of organization / entity
Nursing & Midwifery Faculty University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8888 2886
Email address
sadeghi.ho.46@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, school of Nursing and Midwifery, Iran University of Medical Scienc
Expected recruitment start date
2015-12-22, 1394/10/01
Expected recruitment end date
2016-05-21, 1395/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of combination of Chamomile and Calendula oficinalis on Episiotomy wound healing and pain in nulliparous women
Public title
The effect of combination of Chamomile and Calendula oficinalis on Episiotomy wound healing and pain in nulliparous women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: being primiparous women with age range 18-35 years; gestational age 37-42 weeks; single pregnancy; cephalic presentation;ability to read and write; living with his wife's; insensitivity to special herbal drugs in past; non-smoking and no drug dependence; no history of disease impaired wound healing; Lack PROM more than 18 hours; absence of reconstructive surgery on the vagina and perineum; No rectocel, cystocele severe (grade 2 or higher), wall or mass in the vagina; mediolateral episiotomy without rupture and spread with same amount of Lidocaine; lack of volvo and vaginal inflammation at the beginning of research; body mass index less than 30;. Exclusion criteria: there interfere with the progress of labor; prolonged second stage of labor longer than 2 hours; extend the length of the incision or there tear except episiotomy tear; 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 (10 days postpartum); curettage procedure the first 24 hours after birth; not use the ointment on a regular; puerperal fever; an infection of episiotomy; need to re-stitch the episiotomy.
Age
From 18 years old to 35 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
99
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee Vice chancellor for Research Iran University of Medical Sciences
Street address
Hemmat freeway (beside Milad Tower), Tehran
City
Tehran
Postal code
Approval date
2015-11-11, 1394/08/20
Ethics committee reference number
IR.IUMS.REC.1394.9211373215
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
Episiotomy wound healing
Timepoint
4 hours after delivery, 1 days after delivery, 5 days after delivery ,and 10 days after delivery
Method of measurement
REEDA Scale of wound healing
2
Description
Pain in episiotomy
Timepoint
4 hours after delivery, 1 days after delivery, 5 days after delivery ,and 10 days after delivery.
Method of measurement
Visual analog scale
Secondary outcomes
1
Description
Sedative tablets counting
Timepoint
Tenth day after delivery
Method of measurement
questionnaire
Intervention groups
1
Description
The intervention group: Combined ointment 3 times a day(each 8 hours) for 10 days as much as one finger (equivalent to about 20 mlligrams) to be applied topically on the site of episiotomy
Category
Treatment - Drugs
2
Description
The placebo group: Placebo ointment 3 times a day(each 8 hours) for 10 days as much as one finger (equivalent to about 20 mlligrams) to be applied topically on the site of episiotomy.
Category
Placebo
3
Description
Control group follow the routine of the hospital
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Akbar Abadi Hospital
Full name of responsible person
Bahare Davami
Street address
Molavi Street, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research, School of Nursing and Midwifery, Iran University of Medical Scienc
Full name of responsible person
Dr Frough Rafiea , Dr Ali Javad Mosavi
Street address
Hemmat freeway (beside Milad Tower), Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for Research, School of Nursing and Midwifery, Iran University of Medical Scienc
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
School of Nursing and Midwifery, Iran University of Medical Sciences
Full name of responsible person
Bahare Davami
Position
Master of scince student
Other areas of specialty/work
Street address
Next to the Mottahari hospital, Rashid Yasmi street, Valiasr avenue, Tehran
City
Tehran
Postal code
Phone
00
Fax
Email
ba.davami@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery, Iran University of Medical Sciences
Full name of responsible person
Homa Sadeghi Aval Shahr
Position
Master of scince in midwifery
Other areas of specialty/work
Street address
Next to the Mottahari hospital, Rashid yasmi street, Valiasr avenue, Tehran
City
Tehran
Postal code
Phone
00
Fax
Email
sadeghi.ho.46@iums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Nursing and Midwifery, Iran University of Medical Sciences
Full name of responsible person
Bahare Davami
Position
Master of scince student
Other areas of specialty/work
Street address
Next to the Mottahari hospital, Rashid yasmi street, Valiasr avenue, Tehran
City
Tehran
Postal code
Phone
00
Fax
Email
Ba.davami@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)