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CompletedNCT00609648CARLUpdated Feb 20, 2013

Computer Assisted Relaxation Learning for Dental Offices

An interventional study of Computer Assisted Relaxation Learning and Pamphlet in Dental Anxiety, sponsored by University of Washington. Completed at 5 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-02-20.

Sponsored by University of Washington · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
84
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Dental Anxiety

Keywords

  • Dental Anxiety
  • Dental Phobia
  • Odontophobia
03

In context

Lead sponsor

University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.

Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • High dental injection fear
  • Age 18 and over
  • Healthy with no untreated systemic conditions
  • Able to read and write English

Exclusion criteria

Exclusion Criteria:

  • Heart murmur
  • Known allergies to lidocaine or benzocaine
  • Under 18 year old
  • Untreated systemic conditions
  • Currently receiving medication for anxiety
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
84 participants (actual)

Study arms

  • Experimental
    CARL

    CARL computer program

    Behavioral: Computer Assisted Relaxation Learning

  • Active comparator
    Pamphlet

    Reassuring pamphlet about dental injections

    Behavioral: Pamphlet

Interventions

  • BehavioralComputer Assisted Relaxation Learning

    A self-paced computer program for reducing dental injection fear.

  • BehavioralPamphlet

    A pamphlet reassuring patients about dental injections.

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What researchers measure

Primary outcomes

  1. Modified Interval Scale of Anxiety Response at dental injection appointment

    Time frame: One to two-weeks post-intervention/control

Secondary outcomes

  1. Completion of the behavioral avoidance test

    Time frame: One to two-weeks post-intervention/control

  2. Needle Survey

    Time frame: Immediately post-intervention/control

  3. Modified Dental Anxiety Scale

    Time frame: Immediately post-intervention/control

  4. Dental Fear Survey

    Time frame: Immediately post-intervention/control

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Study locations

5 sites
  • 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
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References and documents

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. PubMed 9670603 ↗
  • 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. PubMed 23690352 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 20, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00609648
Lead sponsor
University of Washington
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)
Responsible party
Sue Coldwell (Study Principal Investigator, University of Washington) — Principal investigator
First posted
Feb 7, 2008
Start date
Jan 2008
Primary completion
Jul 2010
Completion
Jul 2010
Last update
Feb 20, 2013

Study contacts

Susan E Coldwell, PhD
principal investigator · University of Washington

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.

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