NCT02083432

Cognitive Behavioural Treatment of Intra-oral Injection-phobia in 10-16 Year Old Children and Adolescents

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University of Bergen · Academic / Other
• Sex: All
• Age: 10 Years – 16 Years
• Healthy volunteers: Not accepted

Summary

The aims of the study: to explore the possible effectiveness of cognitive behavior treatment (CBT) among children and adolescents with formally diagnosed intra-oral injection phobia (DSM-IV), when performed by specially trained dentists. The patients diagnosed with intra-oral injection phobia according to the diagnostic manual DSM-IV. The effect of cognitive behavior therapy when performed by specially trained dentists will be evaluated. Patients referred to the Centre for Odontophobia, and who meet the inclusion criteria, will be allocated to an immediate treatment group (test group) and a waiting list group (control group) of 30 subjects in each group. After treatment they will be followed up during a 1-year period. Hypotheses are formulated based on the literature and previous population and treatment studies of similar designs among adults at the Centre for Odontophobia.

Detailed description

The aims of the study: to explore the possible effectiveness of cognitive behavior treatment (CBT) among children and adolescents with formally diagnosed intra-oral injection phobia (DSM-IV), when performed by specially trained dentists. The patients diagnosed with intra-oral injection phobia according to the diagnostic manual DSM-IV. The effect of cognitive behavior therapy when performed by specially trained dentists will be evaluated. Patients referred to the Centre for Odontophobia, and who meet the inclusion criteria, will be allocated to an immediate treatment group (test group) and a waiting list group (control group) of 30 subjects in each group. After treatment they will be followed up during a 1-year period. Hypotheses are formulated based on the literature and previous population and treatment studies of similar designs among adults at the Centre for Odontophobia. Inclusion criteria: referred 10-17-yr-olds (N=60) who refused intra-oral injections due to intra-oral injection-phobia. This randomized controlled study consisted of a test group (immediate treatment) and a control group (5 weeks waiting list). A diagnostic interview was performed by trained clinical psychologists, and 5 sessions of CBT were performed by 4 specially trained dentists. Each session had a maximum duration of one hour. Assessment at pre-treatment, post-treatment and 1-yr follow -up included responses from 4 different validated self-report instruments; Children's Fear Survey Schedule-Dental Subscale (CFSS-DS), Blood Phobia Scale (BS), Injection Phobia Scale for Children (IPS-C) and Intra-Oral Injection-Phobia Scale (IOIP). Paired sample t-tests were performed on the sumscores of the self-report instruments pre- , post waitlist, and post- treatment (n=17).

Conditions

• Dental Anxiety

Interventions

Type	Name	Description
BEHAVIORAL	5 session of CBT performed by specially trained dentists	A total of 60 participants are randomly assigned to a 5-weeks waiting list Control Group or directly enrolled to the 5-session of CBT treatment Group. The participants in the waiting list Control Group are enrolled to the treatment Group (5 sessions of CBT) after 5 weeks if they still meet the diagnostic criteria of a specific phobia (according to DSM-IV).

Timeline

• Start date: 2013-12-01
• Primary completion: 2016-06-30
• Completion: 2016-06-30
• First posted: 2014-03-11
• Last updated: 2018-08-16

Locations

1 site across 1 country: Norway