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The effect of oral dill drop on flatulence in patient post cesarean in Sabzevar Mobini hospital

Protocol summary

Summary
One of the side effects of postoperative is abdominal distension or air retention in intestines that due to slowing of peristalsis induced of anesthesia, manipulation of Intestine and inactivity occurs. Sutures due to the abdomen retention are under pressure and opening of sutures after cesarean is more prevalent than any other abdominal surgery. In this study, the effect of dill for reducing flatulence, pain and nausea after the cesarean was reviewed. Hospitalized Women in after cesarean section in Sabzevar MOBINI hospital that had inclusion criteria and didn’t have exclusion criteria interred to this study. Randomly individuals divided into two groups of 64 and after disconnecting the serum and drinking tea, took 40 drops of dill or placebo in 30 cc of urban water, 3 times within 20 minutes. Herbal drop and placebo were similar in terms of size and color, and researcher & patients were unaware of its nature. Severity of flatulence, pain and nausea by using a visual simulation in six colors on a scale of 0 to 5, respectively, (Green) 0: any, 1 (blue): very small, 2 (purple): low, 3 (yellow): medium, 4 (Orange): moderately severe and 5 (red): severe at the end of each 20 min and eventually 120 min after intervention recorded by mother. After the end of the study scores for Severity flatulence, pain and nausea in the placebo and treatment group were compared with each other and also with the starting intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013061212438N3
Registration date: 2013-07-07, 1392/04/16
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-07-07, 1392/04/16
Registrant information
Name
Mohsen Taghizadeh
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1555 0021
Email address
taghizadeh_m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Sabzevar University of Medical Science
Expected recruitment start date
2011-12-22, 1390/10/01
Expected recruitment end date
2012-12-21, 1391/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of oral dill drop on flatulence in patient post cesarean in Sabzevar Mobini hospital
Public title
Reduce flatulence after cesarean
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:38-42 w pregnancy, single pregnancy, alive birth, transverse incision in cesarean, BMI:28-30, 18 -40 years old. Exclusion criteria: allergies to herbal combinations specially dill, differnce in type and volume for sedative and serum with other volunteers .
Age
From 18 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 128
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
Sabzevar University of Medical Science
Street address
Sabzevar University of Medical Science, University blvd, Sabzevar
City
Sabzevar
Postal code
Approval date
2011-08-14, 1390/05/23
Ethics committee reference number
122/1915

Health conditions studied

1

Description of health condition studied
The severity of flatulence
ICD-10 code
R14
ICD-10 code description
Flatulence and related conditions

Primary outcomes

1

Description
The severity of flatulence
Timepoint
3 times within 20 minutes and 120 minutes after the end of the intervention.
Method of measurement
Visual Analogue Scale (VAS)

2

Description
The severity of pain
Timepoint
3 times within 20 minutes and 120 minutes after the end of the intervention.
Method of measurement
Visual Analogue Scale (VAS)

Secondary outcomes

1

Description
Nausea
Timepoint
3 times within 20 minutes and 120 minutes after the end of the intervention.
Method of measurement
Visual Analogue Scale (VAS)

Intervention groups

1

Description
Intervention group:40 drops of oral dill drop in 30 cc water in 3 times within 20 minutes after disconnecting serum and drinking tea.
Category
Treatment - Drugs

2

Description
Contol group:40 drops of placebo drop in 30 cc water in 3 times within 20 minutes after disconnecting serum and drinking tea.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahidan Mobini hospital
Full name of responsible person
Street address
City
Sabzevar

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sabzevar University of Medical Science
Full name of responsible person
Pejhan Akbar
Street address
Sabzevar University of Medical Science, University blvd, Sabzevar
City
Sabzevar
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar University of Medical Science
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
Kashan University of Medical Sciences
Full name of responsible person
Taghizadeh Mohsen
Position
PhD
Other areas of specialty/work
Street address
Kashan University of Medical Sciences, Kashan
City
Kashan
Postal code
Phone
+98 36 1555 0021
Fax
Email
taghizadeh_m@kaums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sabzevar University of Medical Science
Full name of responsible person
Fazel Nasrin
Position
Senior expert
Other areas of specialty/work
Street address
Sabzevar University of Medical Science, University blvd, sabzevar
City
Sabzevar
Postal code
Phone
+98 57 1444 6070
Fax
Email
shohreh1368@yahoo.co.uk
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Barij Essence Research Center of Medicinal Herbs
Full name of responsible person
Mahlouji Mahnaz
Position
Expert in clinical research
Other areas of specialty/work
Street address
City
Postal code
Phone
00
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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