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The effect of Rosemary cream on pain intensity and wound healing of episiotomy in nulliparous women

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History
# Registration date Revision Id
2 2022-01-29, 1400/11/09 215037
1 2019-08-24, 1398/06/02 101186
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  • Protocol summary

    This research will be carried in Motahari Hospital of Marvdasht on 80 nulliparous women with Natural vaginal delivery, including the criteria for entering the study on episiotomy . This is a triple blind study. Researcher, patient and analyst will be blind. To randomly assign samples to each of the two intervention and control groups, four variable blocks are used.Then, in the intervention group, the rosemary cream and the control group from the placebo cream will be used for episiotomy
    This research will be carried in Motahari Hospital of Marvdasht on 92 nulliparous women with Natural vaginal delivery, including the criteria for entering the study on episiotomy . This is a triple-blind study. Researcher, patient and analyst will be blind. To randomly assign samples to each of the two intervention and control groups, four variable blocks are used.Then, in the intervention group, the rosemary cream and the control group from the placebo cream will be used for episiotomy
    این پژوهش در بیمارستان مطهری مرودشت و بر روی 80 نفر از زنان شکم اول با زایمان طبیعی و دارای معیارهای ورود به مطالعه و بر روی زخم اپی زیاتومی انجام خواهد گرفت. این مطالعه سه سویه کور می باشد و محقق ، بیمار و آنالیزگر کور خواهند شد. جهت تخصیص تصادفی نمونه ها به هر یک از 2 گروه مداخله و کنترل از بلوک های 4 تایی متغیر استفاده می گردد. سپس در گروه مداخله از کرم رزماری و در گروه کنترل از کرم دارونما بر روی زخم اپی زیاتومی استفاده خواهد شد.
    این پژوهش در بیمارستان مطهری مرودشت و بر روی 92 نفر از زنان شکم اول با زایمان طبیعی و دارای معیارهای ورود به مطالعه و بر روی زخم اپی زیاتومی انجام خواهد گرفت. این مطالعه سه سویه کور می باشد و محقق ، بیمار و آنالیزگر کور خواهند شد. جهت تخصیص تصادفی نمونه ها به هر یک از 2 گروه مداخله و کنترل از بلوک های 4 تایی متغیر استفاده می گردد. سپس در گروه مداخله از کرم رزماری و در گروه کنترل از کرم دارونما بر روی زخم اپی زیاتومی استفاده خواهد شد.

  • General information

    80
    92
    empty
    80
    No
    No
    empty
    2019-09-01, 1398/06/10
    empty
    2020-03-05, 1398/12/15
    empty
    2020-03-19, 1398/12/29
    empty
    Enter the start and end dates of the completed sampling and the volume of the completed sample
    empty
    وارد کردن تاریخ شروع و پایان نمونه گیری محقق یافته و حجم نمونه محقق یافته

  • Primary outcomes

    #1
    1-5-10 days after childbirth
    1-4-10 days after childbirth
    روزهای 1-5-10 بعد از زایمان
    روزهای 1-4-10 بعد از زایمان
    #2
    1-5-10 days after childbirth
    1-4-10 days after childbirth
    روزهای 1-5-10 بعد از زایمان
    روزهای 1-4-10 بعد از زایمان

  • Person responsible for general inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Fatemeh hadizadeh Talasaz
    Full name of responsible person - Persian: فاطمه هادیزاده طلاساز
    Position - English: Assistant Professor
    Position - Persian: استادیار
    Latest degree: phd
    Area of specialty/work: 1
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Asian Roadside , Gonabad University of Medical Sciences
    Street address - Persian: حاشیه جاده آسیایی، دانشگاه علوم پزشکی گناباد
    City - English: Gonabad
    City - Persian: گناباد
    Province: Razavi Khorasan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: ۹۶۹۱۷۹۳۷۱۸
    Phone: +98 517223028
    Mobile: +98 915 110 4060
    Fax:
    Email: shahnazhadizadeh@yahoo.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Fatemeh Hadizadeh Talasaz
    Full name of responsible person - Persian: فاطمه هادیزاده طلاساز
    Position - English: Assistant Professor
    Position - Persian: استادیار
    Latest degree: phd
    Area of specialty/work: 1
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Asian Roadside , Gonabad University of Medical Sciences
    Street address - Persian: حاشیه جاده آسیایی، دانشگاه علوم پزشکی گناباد
    City - English: Gonabad
    City - Persian: گناباد
    Province: Razavi Khorasan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: ۹۶۹۱۷۹۳۷۱۸
    Phone: +98 517223028
    Mobile: +98 915 110 4060
    Fax:
    Email: shahnazhadizadeh@yahoo.com
    Web page address:

  • Person responsible for scientific inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Fatemeh hadizadeh Talasaz
    Full name of responsible person - Persian: فاطمه هادیزاده طلاساز
    Position - English: Assistant Professor
    Position - Persian: استادیار
    Latest degree: phd
    Area of specialty/work: 1
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Asian Roadside , Gonabad University of Medical Sciences
    Street address - Persian: حاشیه جاده آسیایی، دانشگاه علوم پزشکی گناباد
    City - English: Gonabad
    City - Persian: گناباد
    Province: Razavi Khorasan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: ۹۶۹۱۷۹۳۷۱۸
    Phone: +98 517223028
    Mobile: +98 915 110 4060
    Fax:
    Email: shahnazhadizadeh@yahoo.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Fatemeh Hadizadeh Talasaz
    Full name of responsible person - Persian: فاطمه هادیزاده طلاساز
    Position - English: Assistant Professor
    Position - Persian: استادیار
    Latest degree: phd
    Area of specialty/work: 1
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Asian Roadside , Gonabad University of Medical Sciences
    Street address - Persian: حاشیه جاده آسیایی، دانشگاه علوم پزشکی گناباد
    City - English: Gonabad
    City - Persian: گناباد
    Province: Razavi Khorasan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: ۹۶۹۱۷۹۳۷۱۸
    Phone: +98 517223028
    Mobile: +98 915 110 4060
    Fax:
    Email: shahnazhadizadeh@yahoo.com
    Web page address:

  • Sharing plan

    no
    yes
    undecided
    yes
    undecided
    yes
    Participant information is confidential
    empty
    اطلاعات مشارکت کنندگان محرمانه است.
    empty
    empty
    Only part of the data such as information about the main outcome or the like can be shared.
    empty
    فقط بخشی از داده نظیر اطلاعات مربوط به پیامد اصلی یا امثال آن امکان اشتراک گذاری دارد.
    empty
    6 months after printing the results
    empty
    6 ماه پس از چاپ نتایج
    empty
    Medical researchers
    empty
    محققین علوم پزشکی
    empty
    Available at the reasonable request of researchers.
    empty
    در صورت درخواست معقول محققین، در دسترس است.
    empty
    Corresponding author of the published article
    empty
    نویسنده مسئول مقاله چاپ شده
    empty
    Send email to the Corresponding author
    empty
    ارسال ایمیل به نویسنده مسئول
    empty
    ----------
    empty
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Protocol summary

Study aim
The effect of Rosemary cream on pain intensity and wound healing of episiotomy in nulliparous women
Design
Clinical trials with controlled, triple blind, randomized trials
Settings and conduct
This research will be carried in Motahari Hospital of Marvdasht on 92 nulliparous women with Natural vaginal delivery, including the criteria for entering the study on episiotomy . This is a triple-blind study. Researcher, patient and analyst will be blind. To randomly assign samples to each of the two intervention and control groups, four variable blocks are used.Then, in the intervention group, the rosemary cream and the control group from the placebo cream will be used for episiotomy
Participants/Inclusion and exclusion criteria
Inclusion criteria: nulliparous؛ Gestational age Between 37-42 weeks؛ The age of the mother Between 18-35 years old؛ Single baby؛ Cephalic؛ Natural vaginal delivery and Middle lateral episiotomy؛ Baby weight between 2500-4000 grams؛ No use effective medication for wound healing؛ Lack of amniotic membrane rupture for more than 12 hours؛ Not having midwifery problems at admission؛ exclusion criteria: Increased episiotomy؛ Hematoma in episiotomy after childbirth؛ Unwillingness to continue participating in the study؛ No used the correct cream؛ Mother's sensitivity to the Creams used in the study؛ Symptoms of infection in episiotomy؛ opened Episiotomy؛ Shoulder Dystopia
Intervention groups
In the intervention group, Rosemary cream is used twice a day until the tenth day after delivery on episiotomy ulcer. In the control group, placebo cream is also used in the same way
Main outcome variables
pain intensity and wound healing of episiotomy

General information

Reason for update
Enter the start and end dates of the completed sampling and the volume of the completed sample
Acronym
IRCT registration information
IRCT registration number: IRCT20190308042971N1
Registration date: 2019-08-24, 1398/06/02
Registration timing: prospective

Last update: 2022-01-31, 1400/11/11
Update count: 1
Registration date
2019-08-24, 1398/06/02
Registrant information
Name
Fariba Mardani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 4331 7002
Email address
mardani.f.stu@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-21, 1398/04/30
Expected recruitment end date
2019-10-22, 1398/07/30
Actual recruitment start date
2019-09-01, 1398/06/10
Actual recruitment end date
2020-03-05, 1398/12/15
Trial completion date
2020-03-19, 1398/12/29
Scientific title
The effect of Rosemary cream on pain intensity and wound healing of episiotomy in nulliparous women
Public title
The effect of Rosemary cream on pain intensity and wound healing of episiotomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria:Completion of informed consent form Gestational age Between 37-42 weeks The age of the mother Between 18-35 years old Single baby Cephalic Natural vaginal delivery and Middle lateral episiotomy Baby weight between 2500-4000 grams Iranian-Resident of Marvdasht city and The villages around it Minimum fifth grade primary education Mother in active phase of labor (dilatation 3-4 cm and regular uterine contractions)و BMI is 18/5-24/9 kg / m2 Mother lives with hers husband nulliparous
Exclusion criteria:
indication for cesarean section(Distress fetal, umbilical cord prolapse, diagnosis of the Tight pelvis by the doctor) having midwifery problems at admission(placenta previa،Polyhydramnios، Oligo Hydramnios) amniotic membrane rupture for more than 12 hours clear symptoms of perineal and vaginal infection at the time of admission anemia or thrombocytopenia having diabetes, anemia,Immune system disorders,... use effective medication for wound healing(Glucocorticoids, anticoagulants, immunosuppressants, chemotherapy, alcohol and benzodiazepines) use of drugs and tobacco anal lesions, Perineum or history of surgery on Perineum and cystocel and severe rectus
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 92
Actual sample size reached: 80
Randomization (investigator's opinion)
Randomized
Randomization description
To randomly assign samples to each of the two intervention and control groups, four variable blocks are used. In this way, six of the possible blocks (BBAA, BABA, ABBA, BAAB AABB, ABAB) are first listed, and each one is assigned a number from one to six. Then, randomly, a number is selected from one to six, followed by individuals assigned to the test group (A) and control (B), based on the corresponding block. This will continue until the sample size is completed.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In order to blindness, the drugs prepared with codes A and B were prepared by the pharmacist's assistant, and only themselves knew about their content, the researcher and consultant of statistics and patients did not know the type of cream.
Placebo
Used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee of Gonabad University of Medical Sciences
Street address
Asian Roadside،Gonabad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
۹۶۹۱۷۹۳۷۱۸
Approval date
2018-12-03, 1397/09/12
Ethics committee reference number
IR.GMU.REC.1397.089

Health conditions studied

1

Description of health condition studied
episiotomy
ICD-10 code
O70.1
ICD-10 code description
Second degree perineal laceration during delivery

Primary outcomes

1

Description
wound healing of episiotomy
Timepoint
1-4-10 days after childbirth
Method of measurement
Perineal Improvement Assessment Scale (REEDA)

2

Description
pain intensity
Timepoint
1-4-10 days after childbirth
Method of measurement
Visual Analogue Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Rosemary Cream 30 grams twice a day for 10 days (prepared at the Pharmacological Research Center of Mashhad Medicinal Plants) will be applied to the amount of a fingertip locally on the episiotomy site
Category
Treatment - Drugs

2

Description
Control group: Placebo cream 30 grams twice a day for 10 days (prepared at the Pharmacological Research Center of Mashhad Medicinal Plants) will be applied to the amount of a fingertip locally on the episiotomy site
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Motahari Hospital of Marvdasht
Full name of responsible person
Fariba Mardani
Street address
Teacher's Street
City
Marvdasht
Province
Fars
Postal code
7371676711
Phone
+98 71 4334 2060
Fax
+98 71 4333 4935
Email
mardanif110@gmail.com
Web page address
https://marvhosp.sums.ac.ir/?sub=38

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
shahla khosravan
Street address
Asian Roadside , Gonabad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
۹۶۹۱۷۹۳۷۱۸
Phone
+98 51 5722 3028
Fax
+98 51 5722 0578
Email
khosravan@gmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Fatemeh Hadizadeh Talasaz
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Asian Roadside , Gonabad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
۹۶۹۱۷۹۳۷۱۸
Phone
+98 517223028
Email
shahnazhadizadeh@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Fatemeh Hadizadeh Talasaz
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Asian Roadside , Gonabad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
۹۶۹۱۷۹۳۷۱۸
Phone
+98 517223028
Email
shahnazhadizadeh@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Fariba Mardani
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Asian Roadside , Gonabad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Fax
Email
mardani.f.stu@gmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Only part of the data such as information about the main outcome or the like can be shared.
When the data will become available and for how long
6 months after printing the results
To whom data/document is available
Medical researchers
Under which criteria data/document could be used
Available at the reasonable request of researchers.
From where data/document is obtainable
Corresponding author of the published article
What processes are involved for a request to access data/document
Send email to the Corresponding author
Comments
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