The purpos of this study is comparing the effects of the Emotional regulation strategies and Systematic desensitization on fear and anxiety ' dentistry of adults referred to dentistry
Design
Clinical trial with one control group and two intervention groups. Participants were selected using randomly sampling method (n=60) form individuals referred to dentistry.
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
Inclusion Criteria: Having the dental problems who needing interventions in dentistry and they could not refer to dentistry because of fear and anxiety
Exclusion criteria: Patients that participate in other clinical trial
Intervention groups
Group1:Recieving emotional self-regulation-Group 2:Recieving Systematic desensitization-Group3:Control group no method recieving
Main outcome variables
Main' implication is fear and anxiety that is influenced by research two intervention methods.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220717055481N2
Registration date:2022-10-13, 1401/07/21
Registration timing:retrospective
Last update:2022-10-13, 1401/07/21
Update count:0
Registration date
2022-10-13, 1401/07/21
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
2022-08-17, 1401/05/26
Expected recruitment end date
2022-08-17, 1401/05/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing of effectiveness of Emotional Self-Regulation Strategies and Systematic Desensitization on Fear and Anxiety of Adults referred to Dentistry
Public title
Compare of two ways of Emotional Self-Regulation Strategies and Systematic Desensitization for fear and anxiety reduction
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having dental problems
Need to perform dental intervention
Satisfaction to participate in the research
Exclusion criteria:
Individuals above 20 years old
Individuals who have dental fear and anxiety and we study such individuals to be able to help them to decrease their fear and anxiety.
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
Effecs of systematic desensitization and emotional regulation strategies upon fear and anxiety's reduction
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The primary outcome variable is dental fear and anxiety.
Timepoint
Investigating the effect of two methods on fear and anxiety before the start of the study (before the intervention) and 60 days after the intervention
Method of measurement
Questionnaire of dentistry'anxiety by Staterd and Melberg &Hogstraten, Questionnaire of dentistry'fear by Cutbert & 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
Control Group: Pre and posttest were conducted on control group, however, they were not delivered any instruction. The research method were introduced in detail.
Category
Behavior
3
Description
Intervention group 2: Systematic Desensitization.The systematic desensitization method that was taught for 8 sessions of 1.5 hours is based on relaxation,hierarchy of anxiety,desensitization.Participants were taught to confront situational anxiety and state of relaxiation.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic'Doctor Zahra Parivar
Full name of responsible person
Doctor Zahra 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
Doctor Hassan Rasuli
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
Islamic Azad 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
PayameNoor
Full name of responsible person
Akbar Rezaie
Position
University professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Talegani Ave,PayameNoor
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
Parivar Masumeh
Position
Psychologist
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
Psychologist
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
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