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Children and Adolescents With Dental Anxiety - Randomized Controlled Study of Cognitive Behavioral Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01798355
Recruitment Status : Completed
First Posted : February 25, 2013
Last Update Posted : September 14, 2018
Sponsor:
Collaborator:
Public Dental Health Services, Eastmaninstitutet, Pediatric Dentistry, Sweden
Information provided by (Responsible Party):
Shervin Shahnavaz, Karolinska Institutet

Brief Summary:
The purpose of this study is to determine whether cognitive behaviour therapy is effective in the treatment of children and adolescents with dental anxiety. Our hypothesis is that children and adolescents who have been offered CBT shows significant better performance on outcome measures compared with patients in control group who have received treatment as usual.

Condition or disease Intervention/treatment Phase
Dental Anxiety Behavioral: Cognitive Behavioral Therapy Behavioral: Treatment As Usual Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Children and Adolescents With Dental Anxiety - Randomized Controlled Study of Cognitive Behavioral Therapy
Study Start Date : January 2013
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Cognitive Behavioral Therapy Behavioral: Cognitive Behavioral Therapy
The treatment group is offered cognitive behavior therapy(CBT) by psychologists/psychotherapists. CBT is offered according to a treatment manual and consists of 10- sessions during 12-15 weeks.

Active Comparator: Treatment as usual Behavioral: Treatment As Usual
Treatment as usual consist of strategies such as habituation, tell-show-do, premedication with midazolam, nitrous oxide sedation and general anesthesia. All offered by dentists and dental hygienist and/or dental assistants.




Primary Outcome Measures :
  1. Changes in dental anxiety [ Time Frame: 3 months and 12 months from baseline ]
    Both child and parental versions of Children's Fear Survey Schedule - Dental Subscale will be administered.


Secondary Outcome Measures :
  1. Changes in Behavioral Avoidance [ Time Frame: 3 months and 12 months from baseline ]
    Behavioral Avoidance Test consists of 18 dental situations. The patient is exposed to a situation at a time. Patients receive 1 point for every step he / she manage. The test is stopped when the patient does not want to go further.


Other Outcome Measures:
  1. General psychopathology [ Time Frame: 3 months, 12 months from baseline ]
    Changes in general psychopathology is assessed by Developmental and Well-Being Assessment Questionnaire

  2. Changes in Self efficacy [ Time Frame: 3 months and 12 months from baseline ]
    Self Efficacy is assessed by the Self Efficacy Questionnaire for Specific Phobias



Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patient and parents agree to participate in the research project
  • A primary diagnosis of specific phobia (dental anxiety or needle phobia) can be established according to the Diagnostic and Statistical Manual of Mental Disorders, 4th. Edition.

Exclusion Criteria:

  • The diagnostic interview shows that other psychiatric or developmentally related diagnoses should be consider as the primary diagnosis
  • The patient undergoing psychiatric examination and/or psychotherapy
  • The patient has no dental treatment needs or the dental treatment needs are of an emergency nature.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01798355


Locations
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Sweden
Pediatric Dentistry, Department of Dental Medicine, Karolinska Institutet
Stockholm, Huddinge, Sweden, 14104
Sponsors and Collaborators
Karolinska Institutet
Public Dental Health Services, Eastmaninstitutet, Pediatric Dentistry, Sweden
Investigators
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Study Director: Göran Dahllöf, PhD Department of Dental Medicine, Karolinska Institutet
Principal Investigator: Shervin Shahnaavz, PhD Department of Dental Medicine, Karolinska Institutet
Additional Information:
Publications:
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Responsible Party: Shervin Shahnavaz, PhD, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01798355    
Other Study ID Numbers: KIPED20130218
First Posted: February 25, 2013    Key Record Dates
Last Update Posted: September 14, 2018
Last Verified: September 2018
Keywords provided by Shervin Shahnavaz, Karolinska Institutet:
Dental Fear
Dental Phobia
Cognitive Behavior Therapy
Specific Phobia
Children and Adolescents anxiety
Self Efficacy
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders