Computer Assisted Relaxation Learning for Dental Offices (CARL)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Sue Coldwell, University of Washington
ClinicalTrials.gov Identifier:
NCT00609648
First received: January 24, 2008
Last updated: February 15, 2013
Last verified: February 2013
  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: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Distance Psychology for Treating Dental Fear in Rural Communities

Resource links provided by NLM:


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 ]

Enrollment: 84
Study Start Date: January 2008
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CARL
CARL computer program
Behavioral: Computer Assisted Relaxation Learning
A self-paced computer program for reducing dental injection fear.
Active Comparator: Pamphlet
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

Locations
United States, Oregon
Dr. Gary Templeman, DDS
Corvallis, Oregon, United States, 97330
Michael C Hazel, DMD, PC
West Linn, Oregon, United States, 97068
United States, Washington
Northwest Dental Fears Research
Bremerton, Washington, United States, 98310
Valley View Health Center
Chehalis, Washington, United States, 98632
Dental Fears Research Clinic
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Susan E Coldwell, PhD University of Washington
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sue Coldwell, Study Principal Investigator, University of Washington
ClinicalTrials.gov Identifier: NCT00609648     History of Changes
Other Study ID Numbers: 30641-B, U54DE014254, U01DE016750, U01DE016752
Study First Received: January 24, 2008
Last Updated: February 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
Dental Anxiety
Dental Phobia
Odontophobia

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 22, 2014