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

Dental Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01798355
• Other study ID #: KIPED20130218
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Est. completion date: September 2015

Study information

• Verified date: September 2018
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 19 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Dental Anxiety

Intervention

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.
• 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.

Locations

Country	Name	City	State
Sweden	Pediatric Dentistry, Department of Dental Medicine, Karolinska Institutet	Stockholm	Huddinge

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Public Dental Health Services, Eastmaninstitutet, Pediatric Dentistry, Sweden

Country where clinical trial is conducted

Sweden, 

References & Publications (3)

Shahnavaz S, Hedman E, Grindefjord M, Reuterskiöld L, Dahllöf G. Cognitive Behavioral Therapy for Children with Dental Anxiety: A Randomized Controlled Trial. JDR Clin Trans Res. 2016 Oct;1(3):234-243. doi: 10.1177/2380084416661473. Epub 2016 Aug 15. — View Citation

Shahnavaz S, Hedman-Lagerlöf E, Hasselblad T, Reuterskiöld L, Kaldo V, Dahllöf G. Internet-Based Cognitive Behavioral Therapy for Children and Adolescents With Dental Anxiety: Open Trial. J Med Internet Res. 2018 Jan 22;20(1):e12. doi: 10.2196/jmir.7803. — View Citation

Shahnavaz S, Rutley S, Larsson K, Dahllöf G. Children and parents' experiences of cognitive behavioral therapy for dental anxiety--a qualitative study. Int J Paediatr Dent. 2015 Sep;25(5):317-26. doi: 10.1111/ipd.12181. Epub 2015 Jul 4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	General psychopathology	Changes in general psychopathology is assessed by Developmental and Well-Being Assessment Questionnaire	3 months, 12 months from baseline
Other	Changes in Self efficacy	Self Efficacy is assessed by the Self Efficacy Questionnaire for Specific Phobias	3 months and 12 months from baseline
Primary	Changes in dental anxiety	Both child and parental versions of Children's Fear Survey Schedule - Dental Subscale will be administered.	3 months and 12 months from baseline
Secondary	Changes in Behavioral Avoidance	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.	3 months and 12 months from baseline

External Links

•   Registration website for our study of Internet-based CBT for pediatric dentala anxiety study