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Effect of lavender therapiotic extract in reducing pain and postoperative nausea and vomiting in ‎patients undergoing abdominal non-emergency hysterectomy ‎

Protocol summary

Summary
The aim of this study was to investigate Effect of lavender in reducing pain and postoperative ‎nausea and vomiting in patients undergoing abdominal non-emergency hysterectomy. ‎This clinical trial, a randomized, double-blind, was performed on 104 ‎patients candidate for non-emergency hysterectomy. patients invided to 52 person groups ‎‎(intervention group: 30 drops of the extract orally lavender 50%, placebo: distilled water). VAS ‎and numerical score nausea / vomiting in 4 stages, 15 minutes, 2 hours, 4 and 12 hours were ‎recorded.Inclusion criteria: Persian language, ASA I and II, general anesthesia, No history of cardiovascular and respiratory disease Exclusion criteria: history of Laparatomy, history of cesarean and hysterotomy, history of allergy in Lavender, duration of surgery more than 120 minute, nausa and vomitting

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016092820258N11
Registration date: 2016-10-19, 1395/07/28
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-10-19, 1395/07/28
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice President of Research University of Medical Sciences
Expected recruitment start date
2015-03-21, 1394/01/01
Expected recruitment end date
2016-09-22, 1395/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of lavender therapiotic extract in reducing pain and postoperative nausea and vomiting in ‎patients undergoing abdominal non-emergency hysterectomy ‎
Public title
Effect of lavender therapiotic extract in reducing pain and postoperative nausea and vomiting in ‎patients undergoing abdominal non-emergency hysterectomy ‎
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Persian language, ASA I and II, general anesthesia, No history of cardiovascular and respiratory disease Exclusion criteria: history of Laparatomy, history of cesarean and hysterotomy, history of allergy in Lavender, duration of surgery more than 120 minute, nausa and vomitting
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 104
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
Ethics Committee Of Arak University Of Medical Sciences
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Postal code
848176941
Approval date
2015-12-01, 1394/09/10
Ethics committee reference number
IR.ARAKMU.REC.1394.230

Health conditions studied

1

Description of health condition studied
non-emergency hysterectomy ‎
ICD-10 code
Z90.7
ICD-10 code description
Acquired absence of genital organ(s)

Primary outcomes

1

Description
pain
Timepoint
15 minute and 2 and 4 and 12 hours
Method of measurement
Visual Analogue Scale

2

Description
Nausa and vomitting
Timepoint
15 minute and 2 and 4 and 12 hours
Method of measurement
Likert scale

Secondary outcomes

empty

Intervention groups

1

Description
intervention group:We use 30 drops of the extract orally lavender 50%‎ .
Category
Treatment - Drugs

2

Description
placebo: patient received distilled water‎.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Taleghani hospital
Full name of responsible person
Dr Ashraf Zamani
Street address
Taleghani hospital, Emam Khomeini street, Arak
City
Arak

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research,Arak University of Medical Sciences
Full name of responsible person
Dr Mohammad Rafiee
Street address
Research Center, Payambar Azam complex, Basij square, Sardasht, Arak
City
Arak
Grant name
-
Grant code / Reference number
--
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research,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
Medicine department
Full name of responsible person
Masood Farhadi
Position
medicine student
Other areas of specialty/work
Street address
Arak, Sardasht, Basij squre, Payambar azam complex, medicine department
City
Arak
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
Email
farhadi@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University Of Medical Sciences
Full name of responsible person
Dr Ashraf Zamani
Position
Professor of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Taleghani hospital
City
Arak
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
Email
zamani@arakmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Arak medical science university
Full name of responsible person
Masood Farhadi
Position
medicine student
Other areas of specialty/work
Street address
Taleghani hospital
City
Arak
Postal code
3814957558
Phone
+98 86 3222 2003
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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