Clinical trial NCT00609648: Computer Assisted Relaxation Learning for Dental Offices
Official title: Distance Psychology for Treating Dental Fear in Rural Communities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Anxiety
Keywords: Dental Anxiety
Dental Phobia
Odontophobia
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Dental and Craniofacial Research (NIDCR)
First posted: 2008-02-07
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized study in which two groups will be used to compare the effectiveness of a computerized psychological therapy compared to an information only control group (pamphlet) for reducing fear of dental injections.

Detailed description: This is a randomized study in which two groups will be used to compare the effectiveness of a computerized psychological therapy compared to an information only control group (pamphlet) for reducing fear of dental injections. All patients (96 people with high fear of dental injections) will be tested to assess pre-existing dental fear levels prior to being assigned to study condition. Subsequently, patients in the active treatment group will complete computerized psychological therapy in 1 to 9 weekly 45-minute sessions. Subjects in the control condition will meet with a dental assistant once for approximately 15 minutes to go over a pamphlet. The pamphlet is based on written information developed by a commercial dental web site development company. Following the intervention or control procedures, patients will be reassessed for dental fear using computerized questionnaires. They will also be scheduled to receive a dental injection. Subjects' willingness to complete the dental injection and fear levels during the dental injection will be assessed.

Eligibility criteria: Inclusion Criteria:

* High dental injection fear
* Age 18 and over
* Healthy with no untreated systemic conditions
* Able to read and write English

Exclusion Criteria:

* Heart murmur
* Known allergies to lidocaine or benzocaine
* Under 18 year old
* Untreated systemic conditions
* Currently receiving medication for anxiety

Primary outcomes:
measure: Modified Interval Scale of Anxiety Response at dental injection appointment
timeFrame: One to two-weeks post-intervention/control
Secondary outcomes:
measure: Completion of the behavioral avoidance test
timeFrame: One to two-weeks post-intervention/control
measure: Needle Survey
timeFrame: Immediately post-intervention/control
measure: Modified Dental Anxiety Scale
timeFrame: Immediately post-intervention/control
measure: Dental Fear Survey
timeFrame: Immediately post-intervention/control
Other outcomes:
Locations:
city: Corvallis
country: United States
facility: Dr. Gary Templeman, DDS
state: Oregon
city: West Linn
country: United States
facility: Michael C Hazel, DMD, PC
state: Oregon
city: Bremerton
country: United States
facility: Northwest Dental Fears Research
state: Washington
city: Chehalis
country: United States
facility: Valley View Health Center
state: Washington
city: Seattle
country: United States
facility: Dental Fears Research Clinic
state: Washington
Study officials:
affiliation: University of Washington
name: Susan E Coldwell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Coldwell SE, Getz T, Milgrom P, Prall CW, Spadafora A, Ramsay DS. CARL: a LabVIEW 3 computer program for conducting exposure therapy for the treatment of dental injection fear. Behav Res Ther. 1998 Apr;36(4):429-41. doi: 10.1016/s0005-7967(97)10038-9.
citation: Heaton LJ, Leroux BG, Ruff PA, Coldwell SE. Computerized dental injection fear treatment: a randomized clinical trial. J Dent Res. 2013 Jul;92(7 Suppl):37S-42S. doi: 10.1177/0022034513484330. Epub 2013 May 20.