Children and Adolescents With Dental Anxiety - Randomized Controlled Study of Cognitive Behavioral Therapy
|ClinicalTrials.gov Identifier: NCT01798355|
Recruitment Status : Completed
First Posted : February 25, 2013
Last Update Posted : September 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|Dental Anxiety||Behavioral: Cognitive Behavioral Therapy Behavioral: Treatment As Usual||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
|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.
- 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.
- 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.
- General psychopathology [ Time Frame: 3 months, 12 months from baseline ]Changes in general psychopathology is assessed by Developmental and Well-Being Assessment Questionnaire
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01798355
|Pediatric Dentistry, Department of Dental Medicine, Karolinska Institutet|
|Stockholm, Huddinge, Sweden, 14104|
|Study Director:||Göran Dahllöf, PhD||Department of Dental Medicine, Karolinska Institutet|
|Principal Investigator:||Shervin Shahnaavz, PhD||Department of Dental Medicine, Karolinska Institutet|