Computer Assisted Relaxation Learning for Dental Offices (CARL)
February 15, 2013 updated by: Sue Coldwell, University of Washington
Distance Psychology for Treating Dental Fear in Rural Communities
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
84
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Oregon
-
Corvallis, Oregon, United States, 97330
- Dr. Gary Templeman, DDS
-
West Linn, Oregon, United States, 97068
- Michael C Hazel, DMD, PC
-
-
Washington
-
Bremerton, Washington, United States, 98310
- Northwest Dental Fears Research
-
Chehalis, Washington, United States, 98632
- Valley View Health Center
-
Seattle, Washington, United States, 98195
- Dental Fears Research Clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: CARL
CARL computer program
|
A self-paced computer program for reducing dental injection fear.
|
|
ACTIVE_COMPARATOR: Pamphlet
Reassuring pamphlet about dental injections
|
A pamphlet reassuring patients about dental injections.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Modified Interval Scale of Anxiety Response at dental injection appointment
Time Frame: One to two-weeks post-intervention/control
|
One to two-weeks post-intervention/control
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Completion of the behavioral avoidance test
Time Frame: One to two-weeks post-intervention/control
|
One to two-weeks post-intervention/control
|
|
Needle Survey
Time Frame: Immediately post-intervention/control
|
Immediately post-intervention/control
|
|
Modified Dental Anxiety Scale
Time Frame: Immediately post-intervention/control
|
Immediately post-intervention/control
|
|
Dental Fear Survey
Time Frame: Immediately post-intervention/control
|
Immediately post-intervention/control
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Susan E Coldwell, PhD, University of Washington
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2008
Primary Completion (ACTUAL)
July 1, 2010
Study Completion (ACTUAL)
July 1, 2010
Study Registration Dates
First Submitted
January 24, 2008
First Submitted That Met QC Criteria
January 24, 2008
First Posted (ESTIMATE)
February 7, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
February 20, 2013
Last Update Submitted That Met QC Criteria
February 15, 2013
Last Verified
February 1, 2013
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 30641-B
- U54DE014254 (U.S. NIH Grant/Contract)
- U01DE016750 (U.S. NIH Grant/Contract)
- U01DE016752 (NIH)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.