Computer Assisted Relaxation Learning for Dental Offices - Tabular View

Tracking Information

First Received Date ^ICMJE

January 24, 2008

Last Updated Date

August 4, 2009

Start Date ^ICMJE

January 2008

Estimated Primary Completion Date

July 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00609648 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Computer Assisted Relaxation Learning for Dental Offices

Official Title ^ICMJE

Distance Psychology for Treating Dental Fear in Rural Communities

Brief Summary

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 Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Dental Anxiety

Intervention ^ICMJE

Behavioral: Computer Assisted Relaxation Learning
Behavioral: Pamphlet

Study Arms / Comparison Groups

Experimental: CARL computer program
Active Comparator: Reassuring pamphlet about dental injections

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

July 2010

Estimated Primary Completion Date

July 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Susan E Coldwell, PhD

206-616-3087

scoldwel@u.washington.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00609648

Responsible Party

Susan Coldwell, University of Washington

Study ID Numbers ^ICMJE

30641-B, U54 DE 14254

Study Sponsor ^ICMJE

University of Washington

Collaborators ^ICMJE

National Institute of Dental and Craniofacial Research (NIDCR)

Investigators ^ICMJE

Principal Investigator:

Susan E Coldwell, PhD

University of Washington

Information Provided By

University of Washington

Verification Date

August 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP