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Protocol summary
Randomized clinical trial with two intervention groups, parallel groups, double blind, 80 patients
Randomized clinical trial with two intervention groups, parallel groups, double blind, 120 patients
Randomized clinical trial with two intervention groups, parallel groups, double blind, 80120 patients
کارآزمایی بالینی دارای دو گروه مداخله، با گروه های موازی ، دو سویه کور ، تصادفی شده بر روی 80 بیمار
کارآزمایی بالینی دارای دو گروه مداخله، با گروه های موازی، دو سویه کور، تصادفی شده بر روی 120 بیمار
کارآزمایی بالینی دارای دو گروه مداخله، با گروه های موازی، دو سویه کور، تصادفی شده بر روی 80120 بیمار
بسته های دارویی مشابه بوده و به وسیله فرد دیگری به زنان داده خواهد شد. این فرد از محتویات داخل بسته اطلاعی ندارد. این مطالعه در بیمارستان فاطمیه شهر همدان انجام خواهد گرفت.بنابراین نه محقق و نه زنان از محتویات بسته اطلاع ندارند و کورسازی دو طرفه انجام خواهد شد.
بسته های دارویی مشابه بوده و به وسیله فرد دیگری به زنان داده خواهد شد. این فرد از محتویات داخل بسته اطلاعی ندارد. این مطالعه در بیمارستان فاطمیه شهر همدان انجام خواهد گرفت. بنابراین نه محقق و نه زنان از محتویات بسته اطلاع ندارند و کورسازی دو طرفه انجام خواهد شد.
بسته های دارویی مشابه بوده و به وسیله فرد دیگری به زنان داده خواهد شد. این فرد از محتویات داخل بسته اطلاعی ندارد. این مطالعه در بیمارستان فاطمیه شهر همدان انجام خواهد گرفت.بنابراینگرفت. بنابراین نه محقق و نه زنان از محتویات بسته اطلاع ندارند و کورسازی دو طرفه انجام خواهد شد.
Criteria inclusion: Pregnancy age 37 weeks and higher at delivery time, maternal age 18-35 years, medioteral incision and 2nd degree of episiotomy, not having physical diseases, not having pregnancy complications, not having condyloma or herpes lesions in the perineum Primigravida
Criteria exclusion: Infection during treatment, irregular use of the drug, refuse from continuing to participate in study
Inclusion Criteria: Pregnancy age 37 weeks and higher at delivery time, maternal age 18-35 years, mediolateral incision and 2nd degree of episiotomy, not having physical diseases, not having pregnancy complications, not having condyloma or herpes lesions in the perineum Primigravida
Exclusion Criteria: Infection during treatment, irregular use of the drug, refuse from continuing to participate in study
Inclusion Criteria inclusion: Pregnancy age 37 weeks and higher at delivery time, maternal age 18-35 years, medioteralmediolateral incision and 2nd degree of episiotomy, not having physical diseases, not having pregnancy complications, not having condyloma or herpes lesions in the perineum Primigravida Exclusion Criteria exclusion: Infection during treatment, irregular use of the drug, refuse from continuing to participate in study
Intervention groups:
Chamomile Ointment will be prescribed twice in a day for ten days. This drug will be produced by Hamadan University of Medical Sciences.
Myrtle Ointment will be prescribed twice in a day for ten days. This drug will be produced by Hamadan University of Medical Sciences.
Intervention groups:
Chamomile Ointment will be prescribed twice in a day for ten days. This drug will be produced by Hamadan University of Medical Sciences.
Myrtle Ointment will be prescribed twice in a day for ten days. This drug will be produced by Hamadan University of Medical Sciences.
Placebo Ointment will be prescribed twice in a day for ten days. This drug will be produced by Hamadan University of Medical Sciences.
Intervention groups: Chamomile Ointment will be prescribed twice in a day for ten days. This drug will be produced by Hamadan University of Medical Sciences. Myrtle Ointment will be prescribed twice in a day for ten days. This drug will be produced by Hamadan University of Medical Sciences. Placebo Ointment will be prescribed twice in a day for ten days. This drug will be produced by Hamadan University of Medical Sciences.
گروه های مداخله:
پماد بابونه دو بار در روز به مدت ده روز تجویز می شود. این دارو در دانشگاه علوم پزشکی همدان تولید می شود.
پماد مورت دو بار در روز به مدت ده روز تجویز می شود. این دارو در دانشگاه علوم پزشکی همدان تولید می شود.
گروه های مداخله:
پماد بابونه دو بار در روز به مدت ده روز تجویز می شود. این دارو در دانشگاه علوم پزشکی همدان تولید می شود.
پماد مورت دو بار در روز به مدت ده روز تجویز می شود. این دارو در دانشگاه علوم پزشکی همدان تولید می شود.
پماد دارونما دو بار در روز به مدت ده روز تجویز می شود. این دارو در دانشگاه علوم پزشکی همدان تولید می شود.
گروه های مداخله: پماد بابونه دو بار در روز به مدت ده روز تجویز می شود. این دارو در دانشگاه علوم پزشکی همدان تولید می شود. پماد مورت دو بار در روز به مدت ده روز تجویز می شود. این دارو در دانشگاه علوم پزشکی همدان تولید می شود. پماد دارونما دو بار در روز به مدت ده روز تجویز می شود. این دارو در دانشگاه علوم پزشکی همدان تولید می شود.
General information
80
120
80120
empty
Adding of the placebo group
Adding of the placebo group
empty
اضافه کردن گروه دارونما
اضافه کردن گروه دارونما
Infection during treatment
irregular use of the drug
refuse from continuing to participate in study
Infection during treatment
Irregular use of the drug
Refuse from continuing to participate in study
Infection during treatment irregularIrregular use of the drug refuseRefuse from continuing to participate in study
The Excel computer program by ((Choose (randbetween(1;2) command, Randomly write the number 1 or 2 in front of each of these 80 people so that the people are evenly distributed. In this study, the number one in the group receiving chamomile and the number two in the group receiving Mort will be assigned.
The Excel computer program by ((Choose (randbetween(1;2;3) command, Randomly write the number 1 or 2 or 3 in front of each of these 120 people so that the people are evenly distributed. In this study, the number one in the group receiving chamomile, the number two in the group receiving Mort, and the number three in the group receiving placebo will be assigned.
The Excel computer program by ((Choose (randbetween(1;2;3) command, Randomly write the number 1 or 2 or 3 in front of each of these 80120 people so that the people are evenly distributed. In this study, the number one in the group receiving chamomile and, the number two in the group receiving Mort, and the number three in the group receiving placebo will be assigned.
برنامه کامپیوتری اکسل با دستور ((Choose (randbetween(1;2) به طور تصادفی شماره 1 یا 2 را جلوی هر یک از این 80 نفر می نویسد بدین ترتیب افراد به طور مساوی توزیع میشوند که در این مطالعه شماره یک در گروه دریافت کننده بابونه و شماره دو در گروه دریافت کننده مورت اختصاص خواهند گرفت.
برنامه کامپیوتری اکسل با دستور ((Choose (randbetween(1;2; 3) به طور تصادفی شماره 1 یا 2 یا 3 را جلوی هر یک از این 120 نفر می نویسد بدین ترتیب افراد به طور مساوی توزیع میشوند که در این مطالعه شماره یک در گروه دریافت کننده بابونه و شماره دو در گروه دریافت کننده مورت و شماره 3 دریافت کننده دارونما اختصاص خواهند گرفت.
برنامه کامپیوتری اکسل با دستور ((Choose (randbetween(1;2; 3) به طور تصادفی شماره 1 یا 2 یا 3 را جلوی هر یک از این 80120 نفر می نویسد بدین ترتیب افراد به طور مساوی توزیع میشوند که در این مطالعه شماره یک در گروه دریافت کننده بابونه و شماره دو در گروه دریافت کننده مورت و شماره 3 دریافت کننده دارونما اختصاص خواهند گرفت.
Control group: Placebo Ointment will be prescribed twice in a day for ten days. This drug will be produced by Hamadan University of Medical Sciences.
Control group: Placebo Ointment will be prescribed twice in a day for ten days. This drug will be produced by Hamadan University of Medical Sciences.
empty
گروه کنترل: پماد دارونما دو بار در روز به مدت ده روز تجویز می شود. این دارو در دانشگاه علوم پزشکی همدان تولید می شود.
گروه کنترل: پماد دارونما دو بار در روز به مدت ده روز تجویز می شود. این دارو در دانشگاه علوم پزشکی همدان تولید می شود.
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Saeid Bashirian
Full name of responsible person - Persian: سعید بشیریان
Street address - English: Vice-chancellor for Research, Hamadan University of Medical Sciences, Shahid Fahmideh Av
Street address - Persian: خیابان شهید فهمیده، دانشگاه علوم پزشکی همدان، معاونت تحقیقات
City - English: همدان
City - Persian: همدان
Province: Hamadan
Country: Iran (Islamic Republic of)
Postal code: 6517838695
Phone: +98 81 3838 0717
Fax:
Email: S_bashirian@yahoo.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Saeid Bashirian
Full name of responsible person - Persian: سعید بشیریان
Street address - English: Vice-chancellor for Research, Hamadan University of Medical Sciences, Shahid Fahmideh Av
Street address - Persian: خیابان شهید فهمیده، دانشگاه علوم پزشکی همدان، معاونت تحقیقات
City - English: Hamadan
City - Persian: همدان
Province: Hamadan
Country: Iran (Islamic Republic of)
Postal code: 6517838695
Phone: +98 81 3838 0717
Fax:
Email: S_bashirian@yahoo.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Saeid Bashirian Full name of responsible person - Persian: سعید بشیریان Street address - English: Vice-chancellor for Research, Hamadan University of Medical Sciences, Shahid Fahmideh Av Street address - Persian: خیابان شهید فهمیده، دانشگاه علوم پزشکی همدان، معاونت تحقیقات City - English: همدانHamadan City - Persian: همدان Province: Hamadan Country: Iran (Islamic Republic of) Postal code: 6517838695 Phone: +98 81 3838 0717 Fax: Email: S_bashirian@yahoo.com Web page address:
Protocol summary
Study aim
Phytochemical investigations on myrtle and chamomlie essential oils and their effects on episiotomy
Design
Randomized clinical trial with two intervention groups, parallel groups, double blind, 120 patients
Settings and conduct
The drug packages are similar and given to women by other person. This person does not inform about the package contents.This study is conducted in Fatemieh hospital of Hamadan city. Therefore, neither the researcher nor the women know the contents of the package and double blinding is performed.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Pregnancy age 37 weeks and higher at delivery time, maternal age 18-35 years, mediolateral incision and 2nd degree of episiotomy, not having physical diseases, not having pregnancy complications, not having condyloma or herpes lesions in the perineum Primigravida
Exclusion Criteria: Infection during treatment, irregular use of the drug, refuse from continuing to participate in study
Intervention groups
Intervention groups:
Chamomile Ointment will be prescribed twice in a day for ten days. This drug will be produced by Hamadan University of Medical Sciences.
Myrtle Ointment will be prescribed twice in a day for ten days. This drug will be produced by Hamadan University of Medical Sciences.
Placebo Ointment will be prescribed twice in a day for ten days. This drug will be produced by Hamadan University of Medical Sciences.
Main outcome variables
Wound healing; pain severity
General information
Reason for update
Adding of the placebo group
Acronym
IRCT registration information
IRCT registration number:IRCT20180707040370N7
Registration date:2020-06-15, 1399/03/26
Registration timing:prospective
Last update:2024-01-27, 1402/11/07
Update count:1
Registration date
2020-06-15, 1399/03/26
Registrant information
Name
Ensiyeh Jenabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0496
Email address
e.jenabi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2020-10-22, 1399/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Phytochemical investigations on myrtle and chamomlie essential oils and their effects on episiotomy: double blinded clinical trial
Public title
Phytochemical investigations on myrtle and chamomlie essential oils and their effects on episiotomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Gestational age 37 weeks and higher at delivery time
Maternal age 18-35 years
Mediolateral incision and episiotomy degree 2
No physical diseases
No pregnancy complications
No condyloma or herpes lesions in the perineum
Primigravida
Exclusion criteria:
Infection during treatment
Irregular use of the drug
Refuse from continuing to participate in study
Age
From 18 years old to 35 years old
Gender
Female
Phase
2
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
The Excel computer program by ((Choose (randbetween(1;2;3) command, Randomly write the number 1 or 2 or 3 in front of each of these 120 people so that the people are evenly distributed. In this study, the number one in the group receiving chamomile, the number two in the group receiving Mort, and the number three in the group receiving placebo will be assigned.
Blinding (investigator's opinion)
Double blinded
Blinding description
The drug packages are similar and are given to women by other person. This person does not inform about the package contents.Therefore, neither the researcher nor the women knows the contents of the package and double blinding will be performed.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Hamadan University of Medical Sciences, Fahmiheh Street, Hamadan
City
Hamadan
Province
Hamadan
Postal code
6517838678
Approval date
2020-05-23, 1399/03/03
Ethics committee reference number
IR.UMSHA.REC.1399.217
Health conditions studied
1
Description of health condition studied
Episiotomy
ICD-10 code
O90.1
ICD-10 code description
Disruption of perineal obstetric wound
Primary outcomes
1
Description
Pain severity
Timepoint
Pre intervention, 6 hour and 5 and 10 days after intervention
Method of measurement
Visual analogue scale (VAS)
2
Description
Healing wound
Timepoint
Pre intervention, 6 hour and 5 and 10 days after intervention