Protocol summary

Study aim
Determination of the effect of clinician-patient relationship protocol on controlling vital sign(Heart Rate, Blood Pressure) in emergency endodontic patients
Design
Randomized clinical trial with control group, with single blinded parallel group
Settings and conduct
60 emergency patients referred to endodontic department of dental school Shahid Sadoughi University of Medical Sciences with the age range between 18-65 will be participated in the present study. Vital signs (BP,HR) will be recorded in the four stages: immediately before the treatment, during the anesthesia injection, during tooth preparation and ultimately before the patient discharge. In the control group the clinician will treat the patients without any communication and reduced anxiety protocol and in the case group during the treatment the patient-clinician relationship protocol will be applied.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Age range18-65 , presence of preoperative pain Exclusion criteria:Patients below 18 yrs,pregnant,patients with hypertension and any drug consumption with interaction with hypertension , patients with systemic diseases
Intervention groups
In the case group patient relationship protocol will be applied and in the control group treatment will be done without intervention.
Main outcome variables
patient-clinician relationship protocol ,blood pressure, heart rate

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20150318021507N2
Registration date: 2018-07-30, 1397/05/08
Registration timing: prospective

Last update: 2018-07-30, 1397/05/08
Update count: 0
Registration date
2018-07-30, 1397/05/08
Registrant information
Name
Maryam Kazemipoor
Name of organization / entity
Dental school
Country
Iran (Islamic Republic of)
Phone
+98 35 3625 5881
Email address
m.kazemipoor@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-01, 1397/06/10
Expected recruitment end date
2018-11-11, 1397/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of clinician-patient relationship protocol on vital signs control (Heart Rate, Blood Pressure) in emergency endodontic patients
Public title
Evaluation of the effect of clinician-patient relationship protocol on vital signs control
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age range18-65 presence of preoperative pain
Exclusion criteria:
patients below 18 yrs pregnant patients with hypertension and any drug consumption with interaction with hypertension patients with systemic diseases
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
According to random table ,patients will be assigned to the two control and case groups. Randomization is a fallows: All the participant will be asked to select a number between 1-120 and according to random table they will be assinged into control or case group. Then the secretary will inform the clinician of the assigned groups to accomplish the treatment and intervention based on the related group.
Blinding (investigator's opinion)
Single blinded
Blinding description
Data analyser is not aware of the intervention procedure (clinician-patient relationship protocol).
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shahid Sadoughi university of medical sciences
Street address
Emam Reza Blvd, Emam Reza Square, Dental School, Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8914881167
Approval date
2018-05-20, 1397/02/30
Ethics committee reference number
IR.SSU.REC.1397.012

Health conditions studied

1

Description of health condition studied
Emergency endodontic diseases
ICD-10 code
K04
ICD-10 code description
Diseases of pulp and periapical tissues

Primary outcomes

1

Description
Clinician-patient relationship protocol
Timepoint
will be recorded in the four stages: immediately before the treatment, during the anesthesia injection, during tooth preparation and ultimately before the patient discharge
Method of measurement
Digital Sphygmomanometer OMRON

Secondary outcomes

1

Description
Blood pressure and Heart Rate
Timepoint
four stages: immediately before the treatment, during the anesthesia injection, during tooth preparation and ultimately before the patient discharge
Method of measurement
OMRON Digital Sphygmomanometer

Intervention groups

1

Description
Intervention group: Root canal treatment with intervention of clinician - patient relationship: Having a calm manner, Saying reassuring things, taking seriously telling the patient what was to be done, encouraging the patient to ask questions, not to criticize the patient
Category
Behavior

2

Description
Control group: Root canal treatment without intervention of clinician - patient relationship: Having a calm manner, Saying reassuring things, taking seriously telling the patient what was to be done, encouraging the patient to ask questions, not to criticize the patient
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Dental school, Shahid Sadoughi University of Medical Sciences, Yazd
Full name of responsible person
Maryam Kazemipoor
Street address
Emam Reza Blvd, Emam Reza Square, Dental School, Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8914881167
Phone
+98 35 3625 8813
Email
dr.kazemipoor@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor For research,Shahid Sadoughi University of Medical Scieces
Full name of responsible person
Dr.Masood Mirzaei
Street address
Shahid Sadoughi university of medical sciences, Bahonar square, Yazd
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3149 2248
Email
mmirzaei@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor For research,Shahid Sadoughi University of Medical Scieces
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
Maryam Kazemipoor
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Emam Reza Blvd, Emam Reza Str, Dental School, Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8914881167
Phone
+98 35 3625 8813
Email
dr.kazemipoor@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Maryam Kazemipoor
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Emam Reza Blvd, Emam Reza Str, Dental School, Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8914881167
Phone
+98 35 3625 8813
Email
dr.kazemipoor@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Maryam Kazemipoor
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Emam Reza Blvd, Emam Reza Str, Dental School, Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8914881167
Phone
+98 35 3625 8813
Email
dr.kazemipoor@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
Loading...