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Comparison of the Effectiveness of Acceptance and Commitment Therapy and Cognitive-Behavioral Therapy on Pain Coping Strategies, Severity of Pain Perception, Disaster Pain Imagery, and Pain Related Anxiety in patients with dental anxiety

Protocol summary

Study aim
Determination and Comparison of the effectiveness of therapy based on acceptance and commitment and cognitive-behavioral therapy on Pain Coping Strategies, Severity of Pain Perception, Disaster Pain Imagery, and Pain Related Anxiety in patients with dental anxiety
Design
Controlled clinical trial,with parallel groups,double blinded, randomized design
Settings and conduct
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. Exclusion 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:oral health education
Main outcome variables
Pain Coping Strategies; Severity of Pain Perception; Disaster Pain Imagery; Pain Related Anxiety

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190505043473N2
Registration date: 2020-03-14, 1398/12/24
Registration timing: registered_while_recruiting

Last update: 2020-03-14, 1398/12/24
Update count: 0
Registration date
2020-03-14, 1398/12/24
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
2020-03-01, 1398/12/11
Expected recruitment end date
2020-04-30, 1399/02/11
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 Pain Coping Strategies, Severity of Pain Perception, Disaster Pain Imagery, and Pain Related Anxiety in patients with dental anxiety
Public title
Comparison of the effectiveness of"ACT"and "CBT"on pain
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 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
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
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical sciences, Hezarjarib street
City
isfahan
Province
Isfehan
Postal code
8174619461
Approval date
2020-02-29, 1398/12/10
Ethics committee reference number
IR.MUI.MED.REC.1398.626

Health conditions studied

1

Description of health condition studied
dental anxiety
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
pain Coping Strategies score in Coping Strategies Questionnaire
Timepoint
Before intervention, after intervention, after 3 months
Method of measurement
Coping Strategies Questionnaire

2

Description
Severity of Pain Perception score by McGill Pain Questionnaire
Timepoint
Before intervention, after intervention, after 3 months
Method of measurement
McGill Pain Questionnaire

3

Description
Disaster Pain Imagery score by Pain Catastrophe Scale
Timepoint
Before intervention, after intervention, after 3 months
Method of measurement
Pain Catastrophe Scale

4

Description
Pain Related Anxiety score by Pain Anxiety Symptoms Scale
Timepoint
Before intervention, after intervention, after 3 months
Method of measurement
Pain Anxiety Symptoms Scale

Secondary outcomes

empty

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: oral health education
Category
Other

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
Esfahan University of Medical Sciences
Full name of responsible person
dr shaghayegh hagh joo
Street address
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
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
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
Esfahan University of Medical Sciences
Full name of responsible person
Elham sadat Binandeh
Position
دکترای تخصصی غیر هیات علمی
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
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
binandeh@mail.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Elham sadat binandeh
Position
دکتری تخصصی
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
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
binandeh@mail.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
elham sadat binandeh
Position
دکتری تخصصی
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
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
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
Not applicable
Data Dictionary
Not applicable
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