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Evaluation of the Effect of Speech Instruction on Patients Anxiety with Irrevocable Pulpitis

Protocol summary

Study aim
Determination of the Effect of Speech Instruction on Patients Anxiety with Irrevocable Pulpitis
Design
Clinical trial with control group, with parallel groups, without blindness, Randomized
Settings and conduct
A sequential selection of 96 patients in Yazd Khatam al-Anbia Clinic, completing the questionnaire before each action in both groups, giving the verbal description in the intervention group, and no explanation in the control group, then being treated by an identical endodontist and then filling Repeated questionnaire in two groups
Participants/Inclusion and exclusion criteria
1) Patients who are willing to participate in the study 2) Patients aged 20-65 years 3) No hearing problems 4) Not having diseases such as heart problems, other advance systemic diseases and immunosuppressive diseases 5) Non-pregnant patients 6) Patients who can undergo local anesthesia 7) No history of mental illness 8) Non-use of psychiatric drugs 9) Patients with history of root canal therapy in one of the teeth. Non-entry criteria: Not having entry criteria and 1) Patients who need to root canal therapy except maxillary premolars 2) Patients who need to root canal therapy in maxillary premolar teeth but without irreversible pulpitis, and patients who getting into unpredictable incident during the study
Intervention groups
Providing verbal explanations for 15 minutes before start of the treatment in the intervention group about the diagnosis of the dentist, other alternative treatments if the dentist is diagnosed, how is the treatment, the number of treatment sessions, instruments used in treatment, including turbine, angel, rotary handpiece, dental explorer , Files and other devices, the type of anesthetic used and possible complications after treatment, and don't provide this description for the control group
Main outcome variables
Anxiety Scale in Dental Anxiety Scale

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190717044242N1
Registration date: 2019-07-24, 1398/05/02
Registration timing: retrospective

Last update: 2019-07-24, 1398/05/02
Update count: 0
Registration date
2019-07-24, 1398/05/02
Registrant information
Name
Fatemeh Ayatollahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3625 5881
Email address
f.ayatollahi@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-24, 1397/11/04
Expected recruitment end date
2019-05-05, 1398/02/15
Actual recruitment start date
2019-02-09, 1397/11/20
Actual recruitment end date
2019-06-03, 1398/03/13
Trial completion date
2019-06-03, 1398/03/13
Scientific title
Evaluation of the Effect of Speech Instruction on Patients Anxiety with Irrevocable Pulpitis
Public title
Evaluation of the Effect of Speech Instruction on Patients Anxiety with Irrevocable Pulpitis
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are willing to participate in the study Patients aged 20-65 years No hearing problems No diseases such as heart problems, other advance systemic diseases and immune suppressive diseases Non-pregnant patients Patients who can undergo local anesthesia No history of mental illness No use of psychiatric drugs Patients with history of root canal therapy in one of the teeth
Exclusion criteria:
Patients who need root canal therapy except maxillary premolars Patients who need maxillary premolars root canal therapy but without irreversible pulpitis Patients who getting into unpredictable incident during the study
Age
From 20 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 96
Actual sample size reached: 96
Randomization (investigator's opinion)
Randomized
Randomization description
Regarding the inclusion criteria one patient was considered in the intervention group and the next patient in the control group in succession
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
This study is done with the Parallel scheme and its integration with the design of B and A (Before and After)

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Yazd Shahid Sadoughi University of Medical Sciences
Street address
School of Dentistry, Dahe Fajr BLV, Yazd
City
Yazd
Province
Yazd
Postal code
8914815667
Approval date
2019-01-22, 1397/11/02
Ethics committee reference number
IR.SSU.REC. 1397.152

Health conditions studied

1

Description of health condition studied
Evaluation of the effect of speech instruction on patients anxiety with irrevocable pulpitis
ICD-10 code
ICD-10 code description
Unspecified mental disorder due to known physiological condition

Primary outcomes

1

Description
Anxiety Score in the Dental Anxiety Scale
Timepoint
Measure the anxiety level in the intervention group before intervention and starting treatment and in the control group before and after the treatment
Method of measurement
Dental Anxiety Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: before starting root canal therapy, provide speech instruction about the final diagnosis of the dentist, other alternative treatments if the dentist is diagnosed, how is the treatment, the number of treatment sessions, the instruments used in treatment, including turbine, angel, rotary handpiece, dental explorer, file and other equipment، type of anesthesia to be used and possible complications after treatment for 15 minutes
Category
Behavior

2

Description
Control group: before starting root canal therapy don't provide any speech instruction and doing usuall root canal therapy
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Khatam-ol-Anbia Specialized and Advanced Clinic
Full name of responsible person
Fatemeh Ayatollahi
Street address
Khatam-ol-Anbia Specialized and Advanced Clinic, Adjacent to the Central Laboratory, Taleghani Blv, Yazd
City
Yazd
Province
Yazd
Postal code
8914815667
Phone
+98 35 3726 3154
Email
f.ayatollahi@ssu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Alireza Daneshkazemi
Street address
School of dentistry, Dahe Fajr BLV, Yazd
City
Yazd
Province
Yazd
Postal code
8914815667
Phone
+98 35 3625 5881
Email
adaneshkazemi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Fatemeh Ayatollahi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Dahe Fajr BLV, Yazd
City
Yazd
Province
Yazd
Postal code
8914815667
Phone
+98 35 3625 5881
Email
f.ayatollahi@ssu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Fatemeh Ayatollahi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
School of dentistry, Dahe Fajr BLV, Yazd
City
Yazd
Province
Yazd
Postal code
8914815667
Phone
+98 35 3625 5881
Email
f.ayatollahi@ssu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Fatemeh Ayatollahi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Dahe Fajr BLV, Yazd
City
Yazd
Province
Yazd
Postal code
8914815667
Phone
+98 35 3625 5881
Email
f.ayatollahi@ssu.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
Not applicable
Data Dictionary
Not applicable
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