Determine the effect of Melissa officinalis extract on the anxiety of patients undergoing orthopedic surgeries in Bahonar hospital affiliated to Kerman University of Medical Sciences, 2018.
Design
Randomized clinical trial, triple blinded with parallel group design. Randomization will be done with minimization method.
Settings and conduct
In this clinical trial, the research population are patients candidate for orthopedic surgery admitted to Bahonar Hospital. The sample size is 40 people in each group. Sampling method is convenience and allocation of samples is done by Minimziation method based on anxiety and gender variables. Patients in the intervention group receive 500 mg capsules containing Melissa officinalis extract at 4 and 10 pm before the surgery, and placebo (500mg capsules containing starch) is used in the control group. Before intervention and at 8 am on the operation day, the anxiety of patients in both groups is measured using the Spilberger Situation Questionnaire.
Participants/Inclusion and exclusion criteria
Inclusion criteria: being candidate for orthopedic surgery, being at the age of 18-60 years old, willing to participate in the study. Exclusion criteria: Previous history of orthopedic surgeries and diseases such as asthma, glaucoma, thyroid disorders, psychiatric disorders, pregnancy and lactation.
Intervention groups
Intervention group receives a 500 mg capsule containing the Melissa officinalis extract.
Control group receives a 500 mg capsule containing the starch as a placebo
Main outcome variables
Anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150713023190N4
Registration date:2018-08-05, 1397/05/14
Registration timing:prospective
Last update:2018-08-05, 1397/05/14
Update count:0
Registration date
2018-08-05, 1397/05/14
Registrant information
Name
Tabandeh Sadeghi
Name of organization / entity
Rafsanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3425 5900
Email address
t.sadeghi@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-06, 1397/05/15
Expected recruitment end date
2018-12-06, 1397/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of Melissa officinalis extract on the anxiety of patients undergoing orthopedic surgeries
Public title
effect of Melissa officinalis on the anxiety
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate for orthopedic surgery
Not being emergency patient
Consent for participate in study
Between 18-60 years old
Exclusion criteria:
Previous history of orthopedic surgery
Use of Melissa officinalis regularly
Pregnancy
Lactation
Glaucoma
Hipothyroidism or Hyperthyroidism
Asthma
Suffering from psychosis
Sensitivity to salicylates (ASA)
Using antianxiety or tranquilizing drugs ten day before surgery
Alcoholism
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Random stratifying using minimization
Blinding (investigator's opinion)
Triple blinded
Blinding description
In order to blind patients, the pharmacist is asked to identify the drug and the placebo with numbers one and two so that the researcher does not know about the content of the capsules (drug or placebo). Patients are also given the capsules numbered 1 and 2 and the patient also doesn't know about the content of the capsules. The blinding will also be available for the analyzer, and after completing the analysis, the pharmacist will be asked to disclose the content of the capsules.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committe of Rafsanjan University of Medical Sciences
Street address
Imam Ali Blvd
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Approval date
2018-05-26, 1397/03/05
Ethics committee reference number
IR.RUMS.REC.1397.055
Health conditions studied
1
Description of health condition studied
Surgery anxiety
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Anxiety score from Spielberger situation questionnaire
Timepoint
Pre intervention and post intervention on surgery day at 8.a.m
Method of measurement
Spielberger situation anxiety questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in the intervention group receive 500 mg capsules containing Melissa officinalis extract at 4 and 10 pm before the surgery
Category
Treatment - Drugs
2
Description
Control group: his group receives a 500 mg capsule containing starch as a placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Bahonar Hospital
Full name of responsible person
Motahareh Bagheri
Street address
Gharani Street
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
motahereh.bagheri@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Ali Shamsizadeh
Street address
Imam Ali Blvd
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0097
Email
vcrt@rums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Tabandeh Sadeghi
Position
Assisstant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Parastar Street
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34 3425 5900
Email
t.b_sadeghi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Tabandeh Sadeghi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Parastar Street
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34 3425 5900
Email
t.b_sadeghi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Tabandeh Sadeghi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Parastar
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34 3425 5900
Email
t.b_sadeghi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available