The purposed of this study: investigate the effects of the Emotional regulation strategies and Systematic desensitization based on stress of dentistry for adult 's people visit dentistry
Design
Clinical trial with control group ,paralled group,blined outcome assessment,Randomization with peaple refered to dentistry of 60 patient
Settings and conduct
This study was conducted in Dr. Parivar dental clinic. participants were selected using convenient sampling method and from individuals who refereed to dental clinic. Therefore, 60 participants who their scores were 1 SD higher than Mean value were selected as sample size and classified into three groups including Experimental group 1 and experimental group 2 and control group. They were delivered needed instructions.
Participants/Inclusion and exclusion criteria
Having the problem in dental that needing interventions in dentistry and by having stress ,coulden't refering dentistry
Intervention groups
Group1:Recieving emotional self-regulation-Group 2:Recieving Systematic desensitization-Group3:Control group no method recieving
Main outcome variables
Main' implication is stress that is influenced by research two intervention methods.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220717055481N1
Registration date:2022-08-06, 1401/05/15
Registration timing:retrospective
Last update:2022-08-06, 1401/05/15
Update count:0
Registration date
2022-08-06, 1401/05/15
Registrant information
Name
Masumeh Parivar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3310 7209
Email address
parivar90@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-17, 1401/04/26
Expected recruitment end date
2022-07-17, 1401/04/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing of effectiveness of Emotional Sel-Regulation Strategies and Systematic Desensitization on Stress of Adults referred to Dentistry
Public title
Compare of two ways for stress reduction
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having teeth problem
Need to dentistry intervention
Exclusion criteria:
peaple up 20 years'old
who is having dentistry'stress and studing in this peaple until remove strss
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization, block is used to balance the number of samples allocated for one of studying' groups to be equal the size of all blocks in groups. In this study, size of all 20 blocks (20 participants in group 1, 20 participants in group 2 and 20 participants in control group).
Unit of individual randomization: individuals with stress specified by dentist and individuals who tend to participate in pretest. We made use of randomization statistical software, random allocation using Random' software and also allocation concealment way to prevent of its clearing. We could not determine the allocated group before individual’s allocation due to prevention of weak randomization process. We used opaque sealed envelopes with a random sequence, in which each of the generated random sequences is recorded on a card and the cards are placed in the letter envelopes in order. In order to maintain a random sequence, numbering is done on the outer surface of the envelopes in the same order. Finally, the lids of the envelopes are glued and placed in a box in order. At the time of registration of the participants, based on the order of entry of the eligible participants into the study, one of the envelopes will be opened and the allocated group of that participant will be revealed.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz Islamic Azad university
Street address
Saye2,kaje 12 Ave.,South Sarvestan Street,Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5173865955
Approval date
2022-07-17, 1401/04/26
Ethics committee reference number
IR.IAU.TABRIZ.REC.1401.044
2
Ethics committee
Name of ethics committee
Ethics committee of Tabriz Islamic Azad university
Effecs of systematic desensitization and emotional regulation strategies upon stress's reduction
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The primary outcome variable is dental stress.
Timepoint
Investigating the effect of two methods on stress before the start of the study (before the intervention) and 60 days after the intervention
Method of measurement
Questionnaire of dentistry'stress by Cuthbert & Melamed
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Emotional Self-regulation. The emotional self-regulation method that was taught for 8 sessions of 1.5 hours is based on Gross's theoretical model, which includes five stages (situation selection, situation modification, attention expansion, cognitive expansion, and response adjustment), each of which is a set of strategies includes an adjustment. Participants were taught to identify and correct negative emotion regulation strategies and replace them with positive strategies.
Category
Behavior
2
Description
Intervention group 2: Regular desensitization. The regular desensitizing method was performed in eight sessions of one and a half hours, once a week and in a group. The sessions included (hierarchical identification of anxiety in people, relaxation training (two sessions), visualizing the first scene of the anxiety hierarchy, dealing with stress).
Category
Behavior
3
Description
Control group: control group was not delivered any intervention
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
clinic
Full name of responsible person
Doctor Parivar
Street address
Emam Ave
City
Marand
Province
East Azarbaijan
Postal code
5173865955
Phone
+98 41 3310 7209
Email
Parivar90@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Boss of resercch
Street address
Pasdaran
City
Tabriz
Province
East Azarbaijan
Postal code
5173865955
Phone
+98 41 3310 7209
Email
Parivar90@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
University
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
Islamic Azad University
Full name of responsible person
Akbar Rezaie
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Payame- noor
City
Tabriz
Province
East Azarbaijan
Postal code
5173865955
Phone
+98 41 3310 7209
Email
Parivar90@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Masumeh P arivar
Position
Doctor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Roshdiyeh
City
Tabriz
Province
East Azarbaijan
Postal code
5173865955
Phone
+98 41 3310 7209
Email
Parivar90@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Masumeh Parivar
Position
Doctor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Roshdiye
City
Tabriz
Province
East Azarbaijan
Postal code
5173865955
Phone
+98 41 3310 7209
Email
Parivar90@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
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