Protocol summary

Summary
This study aimed to determine the effect of the essential oil on gastric residual volume in patients with mechanical ventilation in the intensive care unit will be admitted. 50 patients 18 to 60 years with problems of medical-surgical intensive care unit were included in this study and were randomly divided into two groups as well. All patients were treated for 4 days based on a physician's prescription. From the first day to 20 drops of essential oil to the intervention group with 40 ml of water and 40 ml of water will be given to the control group. Daily gastric residual volume measurement and the two groups will be compared with each other.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015080523521N1
Registration date: 2016-01-16, 1394/10/26
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-01-16, 1394/10/26
Registrant information
Name
Fayezeh Tahershamsi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5743 5384
Email address
f.tahershamsi@arakmui.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences, School of Nursing and Midwifery
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2017-02-15, 1395/11/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Zataria Multiflora (Shirazi Thyme) on gastric residual volume in mechanically ventilated patients hospitalized in the Intensive Care Units.
Public title
Effect of Zataria Multiflora (Shirazi Thyme) on gastric residual volume
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 18 -60 years mechanically ventilated patients requiring oral feeding. lack of gallstones, active bleeding, gastrointestinal cancers, gastrointestinal ulcers, diabetes, pancreatitis and gastrointestinal surgeries Lack of pregnancy and lactation patient with no history of food allergies, according to the document duodenal nutrition Exclusion criteria: oral feeding apart from mechanical ventilation fatal withdrawing from continued study or transfer him to the operating room for any kind of emergency surgery
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
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
Arak University of Medical Sciences
Street address
Arak University of Medical Sciences, Alamoll Huda Street, Railroad Street, Arak، Iran
City
Arak
Postal code
3848176941
Approval date
2015-09-14, 1394/06/23
Ethics committee reference number
Ir.arakmu.rec.1394.174

Health conditions studied

1

Description of health condition studied
gastric residual volume
ICD-10 code
k20، k21،
ICD-10 code description
Diseases of oesophagus, stomach and duodenum

Primary outcomes

1

Description
gastric residual volume
Timepoint
Every 3 hours for 4 days
Method of measurement
60 ml syringe

Secondary outcomes

empty

Intervention groups

1

Description
Patients in the intervention group, from the first day for four days and 20 drops of essential oil daily 3 times with 40 ml of water under the brand name Gastrolit be treated. Essential oil and placebo treated innings just before 6 am, 3 pm and 9 pm is indicated. Volume and frequency based on the doctor treated is determined and recorded. Before each treated and residual volume measured during the study.
Category
Treatment - Drugs

2

Description
The control group only 40 ml of water each time as given placebo. Essential oil and placebo treated innings just before 6 am, 3 pm and 9 pm is indicated. Volume and frequency based on the doctor treated is determined and recorded. Before each treated and residual volume measured during the study.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Arak University of Medical Sciences
Full name of responsible person
Korosh Rezaei
Street address
Faculty of Nursing and Midwifery, Arak University of Medical Sciences,Alamoll Huda Street, Railroad Street, Arak، Iran
City
Arak

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Deputy of Arak University of Medical Sciences
Full name of responsible person
Reza baghery
Street address
Faculty of Nursing and Midwifery, Arak University of Medical Sciences, Alamoll Huda Street, Railroad Street, Arak، Iran
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy of Arak University of Medical Sciences
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
Arak University of Medical Sciences
Full name of responsible person
Fayezeh tahershamsi
Position
Bachelor of nursing
Other areas of specialty/work
Street address
Arak University of Medical Sciences, Alamoll Huda Street, Railroad Street Arak
City
Arak
Postal code
8771877981
Phone
+98 31 5743 5384
Fax
+98 31 5724 1024
Email
ftahershamsi@gmail.comf.tahershamsi@arakmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Korosh Rezaei
Position
Msc in Nursing
Other areas of specialty/work
Street address
Arak University of Medical Sciences, Alamoll Huda Street, Railroad Street
City
Arak
Postal code
Phone
+98 86 3417 3524
Fax
+98 86 3417 3505
Email
k.rezaei@arakmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Fayezeh tahershamsi
Position
Bachelor of nursing
Other areas of specialty/work
Street address
Arak University of Medical Sciences, Alamoll Huda Street, Railroad Street, Arak، Iran
City
Arak
Postal code
Phone
+98 31 5743 5384
Fax
+98 31 5724 1024
Email
f.tahershamsi@arakmu.ac.ir
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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