Computer Assisted Relaxation Learning for Dental Offices

NCT ID: NCT00609648

Last Updated: 2013-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2010-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Dental Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CARL

CARL computer program

Group Type EXPERIMENTAL

Computer Assisted Relaxation Learning

Intervention Type BEHAVIORAL

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

Pamphlet

Reassuring pamphlet about dental injections

Group Type ACTIVE_COMPARATOR

Pamphlet

Intervention Type BEHAVIORAL

A pamphlet reassuring patients about dental injections.

Interventions

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Computer Assisted Relaxation Learning

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

Intervention Type BEHAVIORAL

Pamphlet

A pamphlet reassuring patients about dental injections.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Dental and Craniofacial Research (NIDCR)

NIH

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Sue Coldwell

Study Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Susan E Coldwell, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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Dr. Gary Templeman, DDS

Corvallis, Oregon, United States

Site Status

Michael C Hazel, DMD, PC

West Linn, Oregon, United States

Site Status

Northwest Dental Fears Research

Bremerton, Washington, United States

Site Status

Valley View Health Center

Chehalis, Washington, United States

Site Status

Dental Fears Research Clinic

Seattle, Washington, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 9670603 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23690352 (View on PubMed)

Other Identifiers

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U54DE014254

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U01DE016750

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U01DE016752

Identifier Type: NIH

Identifier Source: secondary_id

View Link

30641-B

Identifier Type: -

Identifier Source: org_study_id

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