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

NCT ID: NCT02083432

Last Updated: 2018-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2016-06-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

5-weeks waiting list control

Half of the participants were randomly assigned to 5-weeks waiting list/Control group.The participants in the waiting list/Control Group are enrolled to the treatment Group (INtervention: 5 sessions of CBT) after 5 weeks if they still meet the diagnostic criteria of a specific phobia (according to DSM-IV).

Group Type: ACTIVE_COMPARATOR

5 session of CBT performed by specially trained dentists

Intervention Type: BEHAVIORAL

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).

5 session of CBT

Half of the participants were direct enrolled to 5 weeks(5 sessions) of cognitive behaviour therapy (CBT) performed by specially trained dentists. (Intervention: CBT)

Group Type: EXPERIMENTAL

5 session of CBT performed by specially trained dentists

Intervention Type: BEHAVIORAL

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).

Interventions

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).

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Children between 10 and 16 years old diagnosed by clinical psychologist with Intra-oral injection phobia (DSM-IV 300.29).
• All patients refused to have intra-oral injections in Public Dental Health Clinics.
• Phobia of injections had to be the main phobia during dental treatment.

Exclusion Criteria

• Accept anaesthetic infiltration during behavioural approach test.
• Cognitive impairment.
• Refuse to participate according to the study protocol.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Bergen

OTHER

Sponsor Role: lead

Responsible Party

Marit Slåttelid Skeie

UBergen

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marit S Skeie, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Bergen, Norway

Locations

University of Bergen

Bergen, , Norway

Countries

Norway

Other Identifiers

2010/63

Identifier Type: -

Identifier Source: org_study_id