Protocol summary

Study aim
Determining the prodrug effect of chamomile extract (Matarcaria camomila) on the severity of anxiety before endodontic treatment in anxious patients referred to the endodontic department of Isfahan Dental School
Design
A double-blind randomized controlled clinical trial Sample size 64 people, simple randomization with random number table
Settings and conduct
After explaining the research process to the patient and completing the consent, the patient completes the Modified Dental Anxiety Questionnaire (MDAS). If the score is 11 or higher, the patient is anxious. Then, if the patient is in the control group, consumes 130ml of ordinary water and if the patient is in the intervention group, consumes 30oral drops of chamomile extract in 100 ml of ordinary water. After 60minutes, the anxiety questionnaire is completed again by patients in both groups
Participants/Inclusion and exclusion criteria
Samples of patients referred to the endodontic department of Isfahan Dental School are selected and randomly divided into two categories of intervention and control. Inclusion criteria: The patient is anxious, be mentally healthy and have the ability to fill out the questionnaire, have not used sedatives, the patient has no history of allergies to chamomile, the patient does not have asthma The patient should not take warfarin
Intervention groups
In the control group, the patient consumes 130ml of normal water in a disposable glass with a door whose contents are not visible and in the intervention group, according to the instructions of the manufacturer, the patient takes 30oral drops of chamomile extract produced by Sina Faravar Pharmaceutical Company with the name of Kamazol and the standard mark and drug registration number is 8675081546681476 in 100ml of normal water in a disposable glass with a door whose contents are not visible.
Main outcome variables
Anxiety score

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210516051320N1
Registration date: 2021-08-11, 1400/05/20
Registration timing: retrospective

Last update: 2021-08-11, 1400/05/20
Update count: 0
Registration date
2021-08-11, 1400/05/20
Registrant information
Name
mohammad torabizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3628 8528
Email address
torabizadeh@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-22, 1400/04/01
Expected recruitment end date
2021-07-23, 1400/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of chamomile(matricaria chamomilla) extract on severity of anxiety before root canal therapy in anxious patient
Public title
Evaluation of the effect of chamomile(matricaria chamomilla) extract on severity of anxiety before root canal therapy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
A patient volunteering for endodontic treatment who scores more than 11 and less than 19 on the Anxiety Scale Patient consent The patient has a healthy mental state and the ability to fill out a questionnaire
Exclusion criteria:
The patient has used sedatives The patient has a history of allergy to chamomile The patient has asthma The patient takes warfarin
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 64
Randomization (investigator's opinion)
Randomized
Randomization description
The sample size consists of 64 people who are randomly divided into two groups of 32 intervention and 32 control using the randomization block method. Using the site www.sealedenvelope.com and considering the 8 blocks, patients are divided.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, participants and the physician treating the patient are kept blind because disposable cups with a door that is not visible inside are used and are all coded for consumption in the control and intervention groups. Depending on which group the patient number belongs to, In the control group, the patient consumes 130 ml of normal water in a disposable glass with a door whose contents are not visible and in the intervention group, according to the instructions of the manufacturer, the patient takes 30 oral drops of chamomile extract produced by Sina Faravar Pharmaceutical Company with the name of Kamazol and the standard mark and drug registration number is 8675081546681476 in 100 ml of normal water in a disposable glass with a door whose contents are not visible. In order to eliminate the psychological effect of chamomile smell, the lids of all the glasses in both groups have been pre-soaked with 2 drops of chamomile extract.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Vice-Chancellor in Research Affairs -Medical University of Isfahan
Street address
Hezar Jerib St., Isfahan University of Medical Sciences and Health Services, Building No. 4, Vice Chancellor for Research and Technology
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-03-17, 1399/12/27
Ethics committee reference number
IR.MUI.RESEARCH.REC.1399.836

Health conditions studied

1

Description of health condition studied
Anxiety before root canal treatment
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified

Primary outcomes

1

Description
Anxiety score in MDAS questionnaire
Timepoint
Anxiety scores are measured in two stages before the intervention and one hour after
Method of measurement
Modified Dental Anxiety Questionnaire (MDAS)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the intervention group, according to the instruction of the manufacturer. The patient consumes 30 oral drops of chamomile extract produced by Sina Faravar Pharmaceutical Company with the name of Kamazol and the standard mark and registration number of the drug is 86750815466681476 in 100 ml of ordinary water in a disposable glass with its contents invisible. In order to eliminate the psychological effect of chamomile smell, the lids of all the glasses in both groups are pre-soaked in cotton with 2 drops of chamomile extract.
Category
Prevention

2

Description
Control group: In the control group, the patient consumes 130 ml of ordinary water in a disposable glass with the contents not visible. In order to eliminate the psychological effect of chamomile smell, the lids of all the glasses in both groups have been pre-soaked with 2 drops of chamomile extract.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Dental school of Isfahan University of Medical Science
Full name of responsible person
Alireza Mousavifard
Street address
Hezar Jerib street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3071
Email
international@mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Nakisa Torabinia
Street address
Hezar Jerib St., Isfahan University of Medical Sciences and Health Services, Building No. 4, Vice Chancellor for Research and Technology
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 7898
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Torabizadeh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No. 127, Firooz dead end, Jamalzadeh, Mohtasham Kashani Ave.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3628 8528
Fax
Email
torabizadeh@dnt.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Torabizadeh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No. 127, Firooz dead end, Jamalzadeh, Mohtasham Kashani Ave.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3628 8528
Fax
Email
torabizadeh@dnt.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Torabizadeh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No. 127, Firooz dead end, Jamalzadeh, Mohtasham Kashani Ave.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3628 8528
Fax
Email
torabizadeh@dnt.mui.ac.ir

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
Undecided - It is not yet known if there will be a plan to make this available
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
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