Computer Assisted Relaxation Learning for Dental Offices - Full Text View

Sponsor:	University of Washington
Collaborator:	National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by:	University of Washington
ClinicalTrials.gov Identifier:	NCT00609648

Purpose

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.

Condition	Intervention
Dental Anxiety	Behavioral: Computer Assisted Relaxation Learning Behavioral: Pamphlet

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Distance Psychology for Treating Dental Fear in Rural Communities

Resource links provided by NLM:

MedlinePlus related topics: Anxiety

U.S. FDA Resources

Further study details as provided by University of Washington:

Primary Outcome Measures:

Modified Interval Scale of Anxiety Response at dental injection appointment [ Time Frame: One to two-weeks post-intervention/control ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Completion of the behavioral avoidance test [ Time Frame: One to two-weeks post-intervention/control ] [ Designated as safety issue: No ]
Needle Survey [ Time Frame: Immediately post-intervention/control ] [ Designated as safety issue: No ]
Modified Dental Anxiety Scale [ Time Frame: Immediately post-intervention/control ] [ Designated as safety issue: No ]
Dental Fear Survey [ Time Frame: Immediately post-intervention/control ] [ Designated as safety issue: No ]

Estimated Enrollment:	96
Study Start Date:	January 2008
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
CARL: Experimental CARL computer program	Behavioral: Computer Assisted Relaxation Learning A self-paced computer program for reducing dental injection fear.
Pamphlet: Active Comparator Reassuring pamphlet about dental injections	Behavioral: Pamphlet A pamphlet reassuring patients about 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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00609648

Contacts

Contact: Susan E Coldwell, PhD

206-616-3087

scoldwel@u.washington.edu

Locations

United States, Oregon
Dr. Gary Templeman, DDS	Recruiting
Corvallis, Oregon, United States, 97330
Contact: Gary Templeman, DDS 541-754-8332 gtempleman@proaxis.com
Contact: Jessica Burton 541-754-8332
Principal Investigator: Gary Templeman, DDS
Bruce Burton DMD PC	Withdrawn
Hood River, Oregon, United States, 97031
Michael C Hazel, DMD, PC	Recruiting
West Linn, Oregon, United States, 97068
United States, Washington
Valley View Health Center	Terminated
Chehalis, Washington, United States, 98632
Dental Fears Research Clinic	Recruiting
Seattle, Washington, United States, 98195
Contact: Lisa Heaton, PhD 206-221-6293 lheaton@u.washington.edu
Contact: Susan Coldwell 206-616-3087 scoldwel@u.washington.edu
Principal Investigator: Susan E Coldwell, PhD
Lower Columbia Oral Health	Withdrawn
Longview, Washington, United States, 98632
Northwest Dental Fears Research	Recruiting
Bremerton, Washington, United States, 98310
Contact: Peter Ruff, DDS 360-479-1500
Principal Investigator: Peter Ruff, DDS

Sponsors and Collaborators

University of Washington

National Institute of Dental and Craniofacial Research (NIDCR)

Investigators

Principal Investigator:

Susan E Coldwell, PhD

University of Washington

More Information

Additional Information:

The web site for the dental practice based research network for the study This link exits the ClinicalTrials.gov site

Web site for the center sponsoring the research This link exits the ClinicalTrials.gov site

Study Site This link exits the ClinicalTrials.gov site

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.

Responsible Party:	University of Washington ( Susan Coldwell )
Study ID Numbers:	30641-B, U54 DE 14254
Study First Received:	January 24, 2008
Last Updated:	August 4, 2009
ClinicalTrials.gov Identifier:	NCT00609648 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Washington:

Dental Anxiety
Dental Phobia
Odontophobia

ClinicalTrials.gov processed this record on November 27, 2009