The Efficacy of premedication of PassifloraIncarnata Linnaeus in Reducing Dental Anxiety in Patients referred to endodontic department of dental faculty of Isfahan University of medical sciences in 2019-2020
Design
A single blind; randomized clinical trial with control group and parallel group design; with sample size of 78 patients
Settings and conduct
Place and time of research : the Isfahan Dental School, Autumn & Winter of 2019-2020 .
In this study, patients were blinded. There is also a randomization in this study. For randomization numbers 1 through 3 are written on 78 sheets (1: Passiflora Incarnata 2: Placebo 3: No Medication) and patients are asked take one sheet by chance among the sheets and patients are unaware of their medication.
Participants/Inclusion and exclusion criteria
Inclusion criteria: People whose score on the DAS-R Corah's Anxiety Rating System is above 9; adult. Non-inclusion criteria: drug use; gastrointestinal diseases; psychotropic drugs use; pregnancy; liver and blood problems; having hepatitis and HIV.
Intervention groups
Intervention group 1: PassifloraIncarnata medication- Patients are given 25 drops of PassifloraIncarnata.
Intervention groups 2: placebo- 25 drops of placebo that is quite similar to the original drug, given to the patient.
Control group: without medication- No medication is given to the control group.
Main outcome variables
Anxiety score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200127046277N1
Registration date:2020-03-26, 1399/01/07
Registration timing:retrospective
Last update:2020-03-26, 1399/01/07
Update count:0
Registration date
2020-03-26, 1399/01/07
Registrant information
Name
ali ghazalgoo
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 5547
Email address
alighazalgoo@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2019-12-22, 1398/10/01
Actual recruitment start date
2019-09-23, 1398/07/01
Actual recruitment end date
2019-11-16, 1398/08/25
Trial completion date
2019-11-16, 1398/08/25
Scientific title
Evaluation The Efficacy of premedication of PassifloraIncarnata Linnaeus Compared to placebo on patients' anxiety
Public title
The Efficacy of premedication of PassifloraIncarnata Linnaeus in reducing patients' anxiety
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients whose anxiety score is more than 9 based on the Corah questionnaire
need root canal therapy
Exclusion criteria:
Psychotropic drugs usage
Liver and blood problems
Pregnancy
Gastrointestinal diseases
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
78
Actual sample size reached:
78
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization, 26 sheets of number 1 and 26 sheets of number 2 and 26 sheets of number 3 are written (1: Passiflora Incarnata 2: placebo 3: no medication) and patients are asked take out one sheet to write between sheets by chance.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, placebo is quite similar to the main drug and therefor patients will be kept unaware of their medication.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Dental College; Hezarjerib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2019-12-25, 1398/10/04
Ethics committee reference number
IR.MUI.RESEARCH.REC.1398.555
Health conditions studied
1
Description of health condition studied
anxiety
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition
Primary outcomes
1
Description
Anxiety score
Timepoint
The night before treatment and 90 minutes before treatment
Method of measurement
questionnaire Corah’s Dental Anxiety Scale (DAS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Use of Passiflora-This group will receive the oral premedication of the Passiflora extract. These people will consume 25 drops of the Passiflora extract at the night before the visit and at least 90 minutes before arrival. The therapeutic effects of the Passiflora extract are related to Flavonoids, Alkaloids and sugars. Each 100 ml drop contains about 15 to 15 grams of total flavonoids in terms of hyperoside. The Passiflora extract is produced by Irandarok Pharmaceutical Company.
Category
Treatment - Drugs
2
Description
Intervention group 2: These patients will consume 25 drops of placebo which is completely similar to the extract of the Passiflora , at the night before the visit and at least 90 minutes before the arrival.
Category
Placebo
3
Description
Control group: Do not take any medication
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental College of Isfahan University of Medical Sciences
Full name of responsible person
Dr. Ali Ghazalgo
Street address
Dental College; Hezarjerib street
City
Isfahan
Province
Isfehan
Postal code
7461766998
Phone
+98 31 3792 5547
Email
alighazalgoo@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Nakisa Torabinia
Street address
Isfahan University of Medical Sciences, Hezarjerib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3790 3062
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
Ali Ghazalgoo
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Hezarjerib street
City
Isfahan
Province
Isfehan
Postal code
7461766998
Phone
+98 31 3792 5547
Email
alighazalgoo@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ali Ghazalgoo
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No 16; Golha Ave
City
Isfahan
Province
Isfehan
Postal code
7461766998
Phone
+98 31 3792 5547
Email
alighazalgoo@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Kaffashi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No 39, Kamala avenue
City
Fasa
Province
Fars
Postal code
7461766998
Phone
+98 71 5333 0601
Email
mohammadkaffashi@gmail.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
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