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Completed

NCT Number: NCT02083432

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

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.

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Key information

Conditions

Age range

10 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Bergen

Bergen, 5009, Norway

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

5 session of CBT performed by specially trained dentists

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).

Primary outcomes

  1. Intra-oral injection-phobia in children and adolescents. Prevalence, subgroups and the effect of cognitive behavioral treatment (CBT)

    Time frame: at 1 year follow-up

    Outcome measure: to evaluate whether children and adolescents diagnosed with intraoral injection phobia and treated with CBT, will be able to receive intraoral injections at an external dentist at 1 year follow-up.

Sponsors and collaborators

Lead sponsor

University of Bergen

Other

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Mar 11, 2014
Registry last updated
Aug 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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