This study is designed and implemented to compare the effects of Passion Flower with placebo on the anxiety before the orthopedic surgery in hospitalized patients of Ayatollah Kashani .In this double-blind clinical trial, 60 patients undergoing orthopedic surgery , age ranges between 50 to 25 years old referring to Ayatollah Kashani hospital, are going to be selected and randomly divided into two groups of case and control,30 in each group .The night before the action the case group is going to receive oral drops of Passion Flower and the control group receive placebo . Day of action on the basis of the Spielberger Trait anxiety questionnaire the level of latent anxiety (trait anxiety) and open (state anxiety) were recorded, as well as demographic information is also collected through questionnaires.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201512136480N11
Registration date:2016-01-22, 1394/11/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-01-22, 1394/11/02
Registrant information
Name
Mohammad Taghi Moradi
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 1334 9509
Email address
mtmoradi@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology of Shahrekord University of Medical Sciences
Expected recruitment start date
2015-12-16, 1394/09/25
Expected recruitment end date
2016-02-20, 1394/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of Passion Flower and placebo on reducing anxiety before the orthopedic surgeries
Public title
Passion Flower effect on reducing anxiety before surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age 25 to 50 years, not using psychotropic drugs and filling the informed consent form to participate in the study. Exclusion criteria: allergy to medicinal plants, the use of anesthesia alternative medicines in patients with a history of to mental illness, a history of previous surgery and pregnant women.
Age
From 25 years old to 50 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
Shahrekord , Medical Sciences University Of
Street address
Kashani Blvd, Medical Sciences University Of
City
Shahrekord
Postal code
Approval date
2014-09-26, 1393/07/04
Ethics committee reference number
93-7-8
Health conditions studied
1
Description of health condition studied
Anxiety before the surgury
ICD-10 code
F06.4
ICD-10 code description
Organic anxiety disorder
Primary outcomes
1
Description
The level of anxiety
Timepoint
Before the surgury
Method of measurement
Spielberger anxiety questionnaire
Secondary outcomes
1
Description
Blood pressure
Timepoint
Before and 12 hours after the intervention
Method of measurement
Using barometer
2
Description
pulse
Timepoint
Before and 12 hours after the intervention
Method of measurement
Monitoring device
Intervention groups
1
Description
12 hours before surgery, 10 drops of vegetable oil of Passion Flower as a single dose is given to intervention group .
Category
Treatment - Drugs
2
Description
Control group is given 10 drops of placebo 12 hours before the intervention.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Orthopedic department, Ayatollah Kahani Hospital of Shahrekord