Evaluation of lemon balm on anxiety prior general operation a double blind clinical trial
Design
In this research , after preparation of plant and standardization base on cognition of essential oil constituent, drugs prepare from plant leaves powder as capsule 500 mg and placebo constituent starch . this clinical trial is conducted on 70 patients who refer to Tehran Shariati Hospital for general surgery with ASA (1or2 situation under general anesthesia after fill agreement form and divided based on inclusion and exclusion criteria in two groups.One day before surgery , patients anxiety degree are measured with STAI(state-trait anxiety Inventory).patients in both groups will be received one cap each 6 hours(total 4 cap) one day before surgery, at surgery day ,after patient arrive recovery . patients anxiety will be measured with Visual Analogue Scale.
Settings and conduct
70 patients who refer to Shariati hospital and underwent anesthesia , divided into two groups, drug and placebo and this study is double blinded
Participants/Inclusion and exclusion criteria
Patients refer for general surgery under anesthesia with ASA 1 or 2 situation .patients with heart valve disease ,kidney or hepatic disease ,psychological disturbance back ground ,uncontrolled blood pressure , who with tongue or communication disturbance,thyroid disturbance , pregnancy and lactation dont enterd to research
Intervention groups
The drug group, where patients receive Lemon balm capsules, and the placebo group where patients receive placebo capsules.
Main outcome variables
Relaxation prior surgery , decrease anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141108019860N5
Registration date:2018-02-10, 1396/11/21
Registration timing:registered_while_recruiting
Last update:2018-02-10, 1396/11/21
Update count:0
Registration date
2018-02-10, 1396/11/21
Registrant information
Name
Arman Zargaran
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3230 4279
Email address
zargarana@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-21, 1396/11/01
Expected recruitment end date
2018-08-11, 1397/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Consideration of the efficacy of lemon balm in decreasing anxiety of the patients before general surgery :a randomized double blind clinical trial
Public title
Consideration of the efficacy of lemon balm in decreasing anxiety of the patients before general surgery :a randomized double blind clinical trial
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
patients who candidate for general surgery refer to shariyati hospital with - ASA (1 or 2 ) situation that operate through general anesthesia
Exclusion criteria:
Patients with congestive heart failure
Heart valve disease
Hepatic or kidney disease
Psychiatric disturbance back ground
Uncontrolled blood pressure
Patient with tongue and communication disturbance
Pregnancy or lactation
Thyroid function disturbance
When intubation time is over than 10 second or larangoscopic grade is over than or equal to 3
Age
From 18 years old to 45 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Patients divided into two groups with Block randomization (2:2)
Blinding (investigator's opinion)
Triple blinded
Blinding description
The people who are blinded are participants, principle investigator particularly in investigator initiated trials, healthcare providers (Physicians, nurses, physiotherapists, etc.) who care for participants during the trial, data collectors, outcome assessors.
Drugs and placebos are prepared and labeled by pharmacists and others do not know which ones are drug or placebo.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
School of Persian Medicine, No. 27, Sarparast street, Tehran