Protocol summary

Study aim
Comparing the effect of Funniculum vulgare water and mint water on flatulence after ceaserean
Design
Ninety women randomly divided into 3 groups. Clinical trial study had been terminated
Settings and conduct
Ommolbanin hospital of Mashhad; 90 patients after non urgent cesarean section
Participants/Inclusion and exclusion criteria
Being candidate for non emergency Cesarean section.
Intervention groups
Non-emergency cesarean section mothers were randomly divided into three groups A, B, C, in which 90 cards of the same size and size were prepared on 30 cards of letter A (fennel sweat) on 30 card B (mint sweat) and on 30 other card C (Routine), and the mothers were placed in one of three groups based on the card they chose. The shape used is sweaty anise, containing 50 mg per 100 cc of fennel essential oil. The mint's shape is also sparkling, containing 50 mg per 100 cc of peppermint essential oil. Each person was given a glass of sweet tea, and then the first dose of the drug, depending on the person's choice of card, was given to the fennel sweat, mint or sweetener, and then half an hour later, the abdominal cavity was measured And the sheet for recording the severity of bloating, pain and examination form 1 was completed by the researcher. Then, the second intervention is half an hour after the first time, and the third time is half an hour after the second time, and half an hour later From each intervention, the distance was also measured.
Main outcome variables
Blindness severity; pain severity

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190509043537N1
Registration date: 2019-06-26, 1398/04/05
Registration timing: retrospective

Last update: 2019-06-26, 1398/04/05
Update count: 0
Registration date
2019-06-26, 1398/04/05
Registrant information
Name
Samira Gheichivand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3859 1511
Email address
samira.gheichivand65@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2019-01-21, 1397/11/01
Actual recruitment start date
2018-09-26, 1397/07/04
Actual recruitment end date
2019-01-27, 1397/11/07
Trial completion date
2019-01-27, 1397/11/07
Scientific title
Comparing the effect of Funniculum Vulgare water and Mint water on Flatulance after ceaserean
Public title
Comparing the effect of Funniculum Vulgare water and Mint water on Flatulance after ceaserean
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Nonemergency ceaserean Gestational age between 38-42 weeks Spinal anesthesia BMI under 30 Live in Mashhad
Exclusion criteria:
Need other treatment except Funniculum vulgare water, Mint water and Magnesium Hydroxide syrup Need blood transfusion Have Severe hemorrhage Have emesis and diarrhea Encounter allergy to Funniculum vulgare water, Mint water and Magnesium Hydroxide
Age
From 17 years old to 36 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 90
Actual sample size reached: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Provide 90 cards to the mother and choose a card randomly by mother.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Ibn Sina St.- Crossroads of Ph.D. - Nursing Midwifery Faculty
City
Mashhad
Province
Razavi Khorasan
Postal code
00985135012534
Approval date
2018-04-21, 1397/02/01
Ethics committee reference number
IR.MUMS.REC.1397.021

Health conditions studied

1

Description of health condition studied
Bloating after cesarean section
ICD-10 code
R19.5
ICD-10 code description
Other fecal abnormalities

Primary outcomes

1

Description
Bloating after cesarean section
Timepoint
Half an hour after starting to intake
Method of measurement
Hospital simulation scale

Secondary outcomes

empty

Intervention groups

1

Description
The mothers were placed in one of the groups based on the card they chose to use. The shape used is the sweetened fennel containing 50 mg per 100 cc of fennel essential oil and its active ingredient is anthol, and the mint's shape is also sprayed. It contains 50 mg per 100 cc of asparagus mint, the active ingredients of which are carvone, and are both products of Kashnez Ghasemar.Before the first dose of the drug, in order to select people who have bloating, the visual simulations were given to the mother. They were entered into the study by selecting a blue and higher color, and the abdominal circumference was measured. Each person was discontinued if the sounds of the intestine were heard and the diet The fluids began to be given to each person with a glass of sweet tea, and then the first dose of the drug, which depended on the individual's choice of card, was given fennel sweat, mint or sweetener, and then half an hour later, The stomach was measured and the sheet of bloating, pain, and examination form 1 was completed by the researcher. Then, the second intervention, half an hour D is the first turn and the third time is within half an hour after the second time and within half an hour after each intervention, the distance measurement was also measured and the sheet recording the severity of bloating, pain and examination form 1 was completed by the mother. Scale Visual simulation is a horizontal column, each of which is characterized by a certain color: no bloating (green), very low bloating (blue), low bloating (violet), middle bloating (yellow), relatively flat bloat (orange), and Strong bloating (red) and coded with numbers 0 to 5 without bloating (0), very low bloating (1), low bloating (2), moderate flatulence (3), rather flat bloating (4) severe bloating (5). In case of failure, the gynecologist was informed.
Category
Treatment - Drugs

2

Description
After the onset of the diet and the sound of the intestinal sounds, a 30-cc mint sweat was given with a 30-cc microwave oven and three times every half hour of intervention was repeated, and the visual simulation scale by the mother and the examination form No. 1 were filled by the researcher before and half an hour after each intervention. And the mean changes in bloating intensity were compared before intervention.
Category
Treatment - Drugs

3

Description
Control group: After starting the diet and hearing the sounds of the intestines, a 15-cc syringe was given to the syringe and three times every half hour of intervention, and the visual simulation scale by the mother and the examination form No. 1 by the researcher before and half an hour after each intervention And the changes in the average intensity of bloating were compared before the intervention. 240 ml Magnesium juice produced by the Alborz Drug Company at 15 cc with a glass of water or other fluids after starting the diet three times every half The clock is prescribed.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Um Al-Benin Hospital
Full name of responsible person
Samira Gheichivand
Street address
Ibn Sina St. - Crossroads of Ph.D. - Faculty of Nursing and Midwifery
City
MASHHAD
Province
Razavi Khorasan
Postal code
00985135012534
Phone
+98 51 3859 1511
Email
samira.pourmir@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Taffagodi
Street address
خیابان ابن سینا- چهارراه دکتری- دانشکده پرستاری مامایی
City
Mashad
Province
Razavi Khorasan
Postal code
00985135012534
Phone
+98 51 3859 1511
Email
samira.gheichivand65@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Samira Gheichivand
Position
master Student of Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Ibn Sina St.- Crossroads of Ph.D. - Nursing Midwifery Faculty
City
Mashhad
Province
Razavi Khorasan
Postal code
00985135012534
Phone
+98 51385991511
Email
samira.gheichivan65@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahin Tafazzoli
Position
Associate
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Ibn Sina St.- Crossroads of Ph.D. - Nursing Midwifery Faculty
City
Mashhad
Province
Razavi Khorasan
Postal code
00985135012534
Phone
+98 51 3859 1511
Email
samira.gheichivand65@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Samira Gheichivand
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Ibn Sina St.- Crossroads of Ph.D. - Nursing Midwifery Faculty
City
Masshad
Province
Razavi Khorasan
Postal code
009851359012534
Phone
+98 51 3859 1511
Email
samira.gheichivand65@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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
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