Protocol summary

Study aim
Determining of the Effect of Anethum graveolens L. seed Essential oil on Intestinal Function and Post Cesarean Pain.
Design
Clinical trial on the one hand blind
Settings and conduct
A clinical trial study of one hand blind(statistical analyzer) was performed on 80 cesarean section women in Imam Reza (AS) and Umm Al-Banin (AS) hospitals. Research units are selected by easy sampling and randomly assigned to two intervention groups and a control group. In the control group, routine care is performed. In addition to routine care, the intervention group is given the seeds of dill seeds. Before starting the intervention and at the end of every 20 minutes and then every 4 hours ± 30 minutes to 12 hours after cesarean section, bowel function is measured by measuring the severity of bloating with visual instruments MC Gill is measured.
Participants/Inclusion and exclusion criteria
Iranian. The age is between 18 - 35 years. Have a minimum of literacy. Not be third and more cesarean section or emergency cesarean section. Sign the written consent form. Be Sensory Cesarean section is a spinal and lower transverse incision of the uterus and "fanneistiel " incision. The mother should be fully conscious. The baby should be single, alive, Healthy and term. Do not have speech-hearing problems or an accent that prevents communication with the researcher. Not addicted to drugs, alcohol or tobacco. During the last 6 months, he has not been subjected to major stress Do not suffer from medical conditions Has not used herbal medicines for the past 24 hours. The mother's oral temperature should not be equal to or greater than 38. C. Not be depressed, anxious, or stressed and known to be sensitive to Anethum graveolens L. seed
Intervention groups
The intervention team receives dill seeds in addition to routine care.
Main outcome variables
Intestinal Function and Post Cesarean Pain.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190724044321N1
Registration date: 2020-06-12, 1399/03/23
Registration timing: retrospective

Last update: 2020-06-12, 1399/03/23
Update count: 0
Registration date
2020-06-12, 1399/03/23
Registrant information
Name
Zohreh Yousefi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4322 1495
Email address
yousefizh961@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-22, 1398/09/01
Expected recruitment end date
2020-05-21, 1399/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Effect of Anethum graveolens L. seed Essential oil on Intestinal Function and Post Cesarean Pain.
Public title
Evaluation of the Effect of Anethum graveolens L. seed Essential oil on Intestinal Function and Post Cesarean Pain.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Be Iranian. The age is between 18 - 35 years. Have a minimum of literacy. Not be third and more cesarean section or emergency cesarean section. Sign the Satisfaction letter form. Be Sensory Cesarean section is a spinal and lower transverse incision of the uterus and "fanneistiel" incision. The mother should be fully conscious. The baby should be single and alive and should not be hospitalized in the neonatal intensive care unit. The gestational age should be 37 weeks or more based on the first day of the last menstrual period or the first trimester of pregnancy. Do not have speech-hearing problems or an accent that prevents communication with the researcher. Not addicted to drugs, alcohol or tobacco. During the last 6 months, he has not been subjected to major stress (serious illness of himself and his wife, death of a loved one, migration, accident and severe family disputes). Do not suffer from medical conditions (diabetes, preeclampsia, liver, heart, respiratory, kidney, coagulation, epilepsy, paralysis, mental disorders diagnosed by a psychiatrist or psychologist, vascular thrombosis, autoimmune diseases including MS). Has not used herbal medicines for the past 24 hours. The mother's oral temperature should not be equal to or greater than 38. C. Not be severe depressed, anxious, or stressed It is not known to be sensitive to Anethum graveolens L. seed
Exclusion criteria:
Mother's refusal to participate in Continues research Complications after cesarean section: high blood pressure, bleeding requiring blood transfusion Maternal fever Observe any possible Complications of Anethum graveolens L. seed Essential oil
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
  • Care provider
  • Data analyser
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Blocked by random allocation method, The mothers were divided into two groups, intervention A and control group B. According to the sample size, 5 blocks of 4 (AABB, BBAA, ABAB, AAAA, BBBB) were placed and were divided into two equal groups of intervention and control.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this trial, only the health care provider and the data analyzer (data review with codes A and B) were blinded. Due to the lack of placebo, it was not possible to blind the researcher and the research unit.
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
Qureshi Building, University Street, Mashhad, Iran.
City
Mashhad
Province
Razavi Khorasan
Postal code
9173595199
Approval date
2019-10-22, 1398/07/30
Ethics committee reference number
IR.MUMS.NURSE.REC.1398.058

Health conditions studied

1

Description of health condition studied
K59.9 Functional intestinal disorder , unspecified 082 single delivery by caesarean section
ICD-10 code
K59.9 - 0
ICD-10 code description
K59.9 Functional intestinal disorder , unspecified 082 single delivery by caesarean section

Primary outcomes

1

Description
pain
Timepoint
Before the intervention and then every 20 minutes to 3 times and then every 4 hours ± 30 minutes to 12 hours after cesarean section
Method of measurement
McGill Pain Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In order to prepare Essential oil , dill seeds were approved by the expert of the Department of Medicinal Plants (Herbalium) of Mashhad University of Medical Sciences after preparing them from reputable commercial sources. The grains were then crushed and the essential oil was prepared by hydro distillation using the Clevenger device and dried on sodium sulfate without water and stored in a closed vial at 4 Celsius. 1 cc of the required oil was obtained from 100 grams of dried dill seeds. The required oil was dissolved in a hydro alcoholic solvent (ethanol / water / 80/20) and then poured into 20 cc bottles. The ratio of oil to solvent is 1: 3.The intervention was performed 4 hours after the operation and after completing the relevant forms; In the intervention group, 40 drops of dill seeds were diluted in 30 cc of tap water and given to the patient. Plumbing water was given to the patient, and after 20 minutes again after measuring with the appropriate instrument, the patient was given the third dose similar to the previous two doses. 20 minutes after the end of the third intervention and then every 4 hours +- 30 minutes to 12 hours after the end of the cesarean section, bowel function and pain were measured and recorded again.
Category
Prevention

2

Description
Control group: In this study, due to the start of the intervention in 4 hours after cesarean section and considering that the patient is NPO up to 12 hours after the operation, the control group is without placebo and only receives routine treatment but in 4 hours after cesarean section. Every 20 minutes to 3 times and then every 4 hours for 30 minutes to 12 hours after the relevant cesarean section to complete the bowel function and pain will be completed.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza and U mm Al-Bani Hospital in Mashhad
Full name of responsible person
Zohreh Yousefi
Street address
53, between Golnar 3 and 5, Golnar Street, Neyshabour, Iran
City
Neyshabour
Province
Razavi Khorasan
Postal code
93168-65411
Phone
+98 51 4322 1495
Email
yousefizh961@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghdi
Street address
Between Shahid Javan Square and Al-Shahidi Alley, Shahid Fakoori Boulevard, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9919191778
Phone
+98 51 3841 2081
Email
TafaghodiM@mums.ac.ir
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
Zohreh Yousefi
Position
Master of Midwifery Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
53, between Golnar 3 and 5, Golnar Street, neyshabour, Iran.
City
neyshabour
Province
Razavi Khorasan
Postal code
93168-65411
Phone
+98 51 4322 1495
Email
yousefizh961@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Sedigheh Yousefzadeh
Position
science Committee
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Ibn Sina St., Mashhad, Iran.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
yousefzadehs@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zohreh yousefi
Position
Master of Midwifery Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
University of Nursing and Midwifery,Ibn Sina Street, Mashhad, Iran.
City
Mashhad
Province
Razavi Khorasan
Postal code
93168-65411
Phone
+98 51 4322 1495
Email
yousefizh@mums.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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Effect of Anethum graveolensL. seed Essential oil on Intestinal Function and Post Cesarean Pain
When the data will become available and for how long
2020
To whom data/document is available
Midwifery students
Under which criteria data/document could be used
Systematic review
From where data/document is obtainable
Email
What processes are involved for a request to access data/document
Articles published in this field will be sent to the applicant.
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