Comparison of the effectiveness of acceptance and commitment therapy and cognitive-behavioral therapy on dental anxiety, cognitive emotion regulation and oral health-related quality of life in patients with dental anxiety
Determining and Comparing the effectiveness of therapy based on acceptance and commitment and cognitive-behavioral therapy on dental anxiety, cognitive emotion regulation and quality of life associated with oral health in patients with dental anxiety
Forty-eight participants who were eligible for inclusion in the study were randomly classified into three groups by a statistics consultant. The groups included acceptance and commitment therapy, cognitive-behavioral therapy, and control. Then, the participants who were blind to the intervention were invited to attend separate sessions at the dental research center of Isfahan University of Medical Sciences. The assessors, except for the researcher, gave the encoded dental anxiety scale, cognitive emotion regulation questionnaire, and oral health-related quality of life scale to the participants to complete at pretest, posttest, and three-month follow-up. Each therapy included ten 90-minute sessions per week.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age between 19-50 years old; Having the dental anxiety.
Non-inclusion criteria: need for emergent dental care.
Intervention groups
Intervention group1:In this group the treatment will be done according to acceptance and commitment therapy using the model presented by Haze 2016.
Intervention group2:In this group the treatment will be done according to cognitive-behavioral therapy using the model presented by by Ost,Öst & Skaret 2013.
control group:patients will not receive any treatment during the study
Main outcome variables
Dental anxiety;cognitive emotion regulation;oral health-related quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190505043473N1
Registration date:2019-06-27, 1398/04/06
Registration timing:retrospective
Last update:2019-06-27, 1398/04/06
Update count:0
Registration date
2019-06-27, 1398/04/06
Registrant information
Name
Elham Binandeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 5512
Email address
binandeh@mail.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-05, 1398/02/15
Expected recruitment end date
2019-06-21, 1398/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of acceptance and commitment therapy and cognitive-behavioral therapy on dental anxiety, cognitive emotion regulation and oral health-related quality of life in patients with dental anxiety
Public title
Comparison of the effectiveness of"ACT"and"CBT"on dental anxiety
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
People living in Isfahan
age between 19-50 years old
higher education level than middle school
Willingness to attend intervention sessions and giving written consent
minimum physical and cognitive abilities for participating in psychological interventions
Supplementary studying of psychiatric criteria using SCL-90-R self-report questionnaire
Having the dental anxiety using Stouthard dental anxiety Inventory
Having at least 20 natural teeth
Additional confirmation of dental anxiety will report by pulse oximeters by a dentist. Heart rate of each patient will be measured after relaxing for 5 minutes in the waiting room for 2 times.Then it will be measured twice during the dental treatment, and the mean values will be compared.If the second measure was at least 5 beats per minute higher than the first one, the patient will participate in the study
Having at least one treated teeth
Exclusion criteria:
systemic diseases or congenital syndromes approved by an internal specialist
sensation of pain byVAS (score higher than1)
psychiatric disorders except dental anxiety according to DSM-5 criteria
need for emergent dental care approved by a dentist
Graduated in any fields of dentistry and psychology
receiving psychiatric therapies and chemical drugs in the last six months
Age
From 19 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Individual randomization will be implemented by blinded statistician, using the block randomization method and black concealed pocket
Blinding (investigator's opinion)
Double blinded
Blinding description
participants, Evaluators and statistical consultant Will be unaware of the type of intervention
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad University - Ahvaz Branch
Street address
Islamic Azad University - Ahvaz Branch, Farhangshahr, Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6134937333
Approval date
2019-04-30, 1398/02/10
Ethics committee reference number
IR.IAU.AHVAZ.REC.1398.005
Health conditions studied
1
Description of health condition studied
Dental anxiety
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Dental anxiety score in Stouthard dental anxiety Inventory
Timepoint
Before intervention, after intervention, after 3 months
Method of measurement
Stouthard dental anxiety Inventory
Secondary outcomes
1
Description
cognitive emotion regulation
Timepoint
Before intervention, after intervention, after 3 months
Method of measurement
Cognitive Emotion Regulation Questionnaire by Spinhoven with 36 questions
2
Description
Oral Health-related Quality of Life
Timepoint
Before intervention, after intervention, after 3 months
Method of measurement
Oral Health-related Quality of Life (OHIP-14)
Intervention groups
1
Description
Intervention group: Therapy based on acceptance and commitment: This treatment approach has six central processes that ultimately lead to psychological flexibility. These processes include acceptance, cognitive discontinuity, self as the background, relationship with the present time, values, and committed action . In this research, therapy based on acceptance and commitment will be implemented in 10 sessions (90 minutes each) using a treatment package (Haze, 2016).
Category
Other
2
Description
Intervention group: Cognitive-Behavioral Therapy: A kind of psychotherapy that helps patients to reach thoughts and feelings that affect their behavior. The cognitive-behavioral training and therapeutic sessions refer to sessions that will be conducted for at least 10 sessions (90 minutes each), during which cognitive-behavioral techniques will be taught using cognitive-behavioral therapy for anxiety and dental phobias package(Ost, Öst, & Skaret, 2013).
Category
Other
3
Description
Control group: Control group will not receive any treatment during the study period , However, after the end of the research, the intervention will be done for them, free of charge.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
ِDental Research Center of Isfahan University of Medical Sciences
Full name of responsible person
Elham Sadat Binandeh
Street address
ِDental Research Center, Isfahan University of Medical Sciences, Hezar jarib street , Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5512
Fax
+98 31 3792 5569
Email
binandeh@mail.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hossein Vaghefpour
Street address
Persian gulf international Branch, Islamic Azad University, Kooye Moein
City
Khorramshahr
Province
Khouzestan
Postal code
711
Phone
+98 61 5354 7515
Fax
+98 61 5354 7515
Email
h_vaghefpour@yahoo.com
Web page address
http://pajohesh.iaupg.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
80
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
2
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Omid Savabi
Street address
Dental research Center of Isfahan University of Medical sciences, Hezarjarib street
City
Isfahan
Province
Isfehan
Postal code
8174619461
Phone
+98 31 3792 5512
Fax
+98 31 3792 5569
Email
research@dnt.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
20
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
Elham sadat Binandeh
Position
Ph.D student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No19, No 3 alley, Baborahme Ave ,Isfahan Town
City
Isfahan
Province
Isfehan
Postal code
8136644443
Phone
+98 31 3792 5512
Fax
+98 31 3792 5569
Email
binandeh@mail.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Elham sadat Binandeh
Position
Ph.D student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No19, No 3 alley, Baborahme Ave.
City
Isfahan
Province
Isfehan
Postal code
8136644443
Phone
+98 31 3792 5512
Fax
+98 31 3792 5569
Email
binandeh@mail.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Elham sadat Binandeh
Position
دانشجوی دکتری تخصصی
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No19, No 3 alley, Baborahme Ave.
City
Isfahan
Province
Isfehan
Postal code
8136644443
Phone
+98 31 3792 5512
Fax
+98 31 3792 5569
Email
binandeh@mail.mui.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
Not applicable
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