Comparison of the effects of the herb of valerian oil (valeriana officinalis) and lavender (lavandula angustifolia MILL) with diazepam on preoperative anxiety in patients between 48-14 years old
This study aimed to compare the effects of two drugs of valeriana officinalis and lavandula angustifolia essential oil with diazepam on preoperative anxiety in hospitalized patients in Kashani hospital. In this double blind clinical trial, 120 patients undergoing moderate elective surgery, the average age range of 14- 48 years with no history of previous surgery, mental illness and sensitivity to valerian and lavender were recruited by convenience sampling method. Patients were randomly divided into four groups of 30 recipients of lavender (5cc edible oil manufactured by Zardband pharmaceutical company ), valerian (5 cc concentrated extracts manufactured by theZardband pharmaceutical company ), diazepam (tablets 5mg) and placebo, respectively. The person who Completed the questionnaire, the patients and researchers were not aware of the type of treatment. The individual state anxietyscore before and 2 hours after drug administration through STAI questionnaire was calculated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014121018099N2
Registration date:2015-10-10, 1394/07/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-10-10, 1394/07/18
Registrant information
Name
Gholamreza Shabanian
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 3333 0061
Email address
gshabanian@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahrekord University of Medical sciences
Expected recruitment start date
2013-01-01, 1391/10/12
Expected recruitment end date
2014-04-01, 1393/01/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of the herb of valerian oil (valeriana officinalis) and lavender (lavandula angustifolia MILL) with diazepam on preoperative anxiety in patients between 48-14 years old
Public title
Effects of two herbal medicine of valeriana officinalis and lavandula angustifolia MILLon preoperative anxiety
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients between the age of 14- 48 years old refering to Ayatollah Kashani hospital, Shahrekord, Iran; patients undergoing moderate elective surgery; patient satisfactionto prticipate in the study. Exclusion criteria: patients with a history of mental illness, previous surgery; patients sensitive to valeriana officinalis, lavandula angustifolia or both.
Age
From 14 years old to 48 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
120
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
Shahrekord University of Medical Sciences
Street address
Shahrekord University of Medical Sciences, Kashani Blvd, Shahrekord
City
Sharekord
Postal code
Approval date
2013-01-01, 1391/10/12
Ethics committee reference number
1171
Health conditions studied
1
Description of health condition studied
Anxiety before the surgery
ICD-10 code
F40
ICD-10 code description
Phobic anxiety disorders
2
Description of health condition studied
Eective surgery
ICD-10 code
Y83.8
ICD-10 code description
Other surgical procedures
Primary outcomes
1
Description
Anexity before the surgry
Timepoint
Before and 2 hours after prescription of drug
Method of measurement
Anxiety (STAI) Questionaire
Secondary outcomes
1
Description
Vital signs (blood pressure, pulse and respiration)
Timepoint
Before and 2 hours after prescribtion of drug
Method of measurement
Monitoring devices
2
Description
Vital signs (blood pressure, pulse and respiration)
Timepoint
Before and 2 hours after drug administration
Method of measurement
Monitoring devices
Intervention groups
1
Description
Edible oil of lavender, 5 ml single dose
Category
Treatment - Drugs
2
Description
Diazepam tablets, 5 mg single dose
Category
Treatment - Drugs
3
Description
Placebo: single dose
Category
Placebo
4
Description
Edible oil symbol of valerian, 5 ml single dose
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Kashani Hospital
Full name of responsible person
Dr. Gholamreza Shabanian
Street address
Surgery Department, Ayatollah Kashani Hospital
City
Shahrekord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology, Shahrekord University of Medical Sciences
Full name of responsible person
Dr. Mahmoud Mobasheri
Street address
Shahrekord University of Medical Sciences, Kashani Blvd.
City
Shahrekord
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 and Technology, Shahrekord University of Medical Sciences