Computer Assisted Relaxation Learning for Dental Offices
CARL
Distance Psychology for Treating Dental Fear in Rural Communities
4 other identifiers
interventional
84
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2008
Typical duration for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
January 24, 2008
CompletedFirst Posted
Study publicly available on registry
February 7, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedFebruary 20, 2013
February 1, 2013
2.5 years
January 24, 2008
February 15, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Modified Interval Scale of Anxiety Response at dental injection appointment
One to two-weeks post-intervention/control
Secondary Outcomes (4)
Completion of the behavioral avoidance test
One to two-weeks post-intervention/control
Needle Survey
Immediately post-intervention/control
Modified Dental Anxiety Scale
Immediately post-intervention/control
Dental Fear Survey
Immediately post-intervention/control
Study Arms (2)
CARL
EXPERIMENTALCARL computer program
Pamphlet
ACTIVE COMPARATORReassuring pamphlet about dental injections
Interventions
A self-paced computer program for reducing dental injection fear.
Eligibility Criteria
You may qualify if:
- High dental injection fear
- Age 18 and over
- Healthy with no untreated systemic conditions
- Able to read and write English
You may not qualify if:
- Heart murmur
- Known allergies to lidocaine or benzocaine
- Under 18 year old
- Untreated systemic conditions
- Currently receiving medication for anxiety
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Dr. Gary Templeman, DDS
Corvallis, Oregon, 97330, United States
Michael C Hazel, DMD, PC
West Linn, Oregon, 97068, United States
Northwest Dental Fears Research
Bremerton, Washington, 98310, United States
Valley View Health Center
Chehalis, Washington, 98632, United States
Dental Fears Research Clinic
Seattle, Washington, 98195, United States
Related Publications (2)
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.
PMID: 9670603BACKGROUNDHeaton 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.
PMID: 23690352DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Susan E Coldwell, PhD
University of Washington
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Study Principal Investigator
Study Record Dates
First Submitted
January 24, 2008
First Posted
February 7, 2008
Study Start
January 1, 2008
Primary Completion
July 1, 2010
Study Completion
July 1, 2010
Last Updated
February 20, 2013
Record last verified: 2013-02