Computer Assisted Relaxation Learning for Dental Offices

Dental Anxiety Clinical Trial

— CARL  

Official title:

Distance Psychology for Treating Dental Fear in Rural Communities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00609648
• Other study ID #: 30641-B
• Secondary ID: U54DE014254U01DE
• Status: Completed
• Phase: N/A
• First received: January 24, 2008
• Last updated: February 15, 2013
• Start date: January 2008
• Est. completion date: July 2010

Study information

• Verified date: February 2013
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dental Anxiety

Intervention

Behavioral:
• Computer Assisted Relaxation Learning
A self-paced computer program for reducing dental injection fear.
• Pamphlet
A pamphlet reassuring patients about dental injections.

Locations

Country	Name	City	State
United States	Northwest Dental Fears Research	Bremerton	Washington
United States	Valley View Health Center	Chehalis	Washington
United States	Dr. Gary Templeman, DDS	Corvallis	Oregon
United States	Dental Fears Research Clinic	Seattle	Washington
United States	Michael C Hazel, DMD, PC	West Linn	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institute of Dental and Craniofacial Research (NIDCR)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Interval Scale of Anxiety Response at dental injection appointment		One to two-weeks post-intervention/control	No
Secondary	Completion of the behavioral avoidance test		One to two-weeks post-intervention/control	No
Secondary	Needle Survey		Immediately post-intervention/control	No
Secondary	Modified Dental Anxiety Scale		Immediately post-intervention/control	No
Secondary	Dental Fear Survey		Immediately post-intervention/control	No

External Links

•   Web site for the center sponsoring the research