Dental AnxietyCARLNCT00609648
Computer Assisted Relaxation Learning for Dental Offices
A study testing Computer Assisted Relaxation Learning and Pamphlet in people with Dental Anxiety, run by University of Washington at 5 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety
- What is being tested?
- Computer Assisted Relaxation Learning and Pamphlet
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 5 sitesUnited States
- Study dates
- Jan 2008to Jul 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- High dental injection fear
- Age 18 and over
- Healthy with no untreated systemic conditions
- Able to read and write English
Who cannot join
- Heart murmur
- Known allergies to lidocaine or benzocaine
- Under 18 year old
- Untreated systemic conditions
- Currently receiving medication for anxiety
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Northwest Dental Fears Research
Bremerton, Washington, 98310
Valley View Health Center
Chehalis, Washington, 98632
Dr. Gary Templeman, DDS
Corvallis, Oregon, 97330
Dental Fears Research Clinic
Seattle, Washington, 98195
Michael C Hazel, DMD, PC
West Linn, Oregon, 97068
About this study
Official title: Distance Psychology for Treating Dental Fear in Rural Communities
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.
- Conditions
- Dental Anxiety
- Being tested
- Computer Assisted Relaxation Learning, Pamphlet
- Keywords
- Dental Anxiety, Dental Phobia, Odontophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer Assisted Relaxation LearningBehavioural
A self-paced computer program for reducing dental injection fear.
PamphletBehavioural
A pamphlet reassuring patients about dental injections.
| Study group | Role | What they receive |
|---|---|---|
| CARL | Experimental | CARL computer program Receives: Behavioral: Computer Assisted Relaxation Learning |
| Pamphlet | Active comparator | Reassuring pamphlet about dental injections Receives: Behavioral: Pamphlet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Interval Scale of Anxiety Response at dental injection appointment
Measured: One to two-weeks post-intervention/control
Secondary outcomes (4)
Completion of the behavioral avoidance test
Measured: One to two-weeks post-intervention/control
Needle Survey
Measured: Immediately post-intervention/control
Modified Dental Anxiety Scale
Measured: Immediately post-intervention/control
Dental Fear Survey
Measured: Immediately post-intervention/control
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dental AnxietyStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Principal investigator, Sue Coldwell, University of Washington
- Investigators
- Susan E Coldwell, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00609648
- Sponsor's protocol ID
- 30641-B
- Other IDs
- U54DE014254, U01DE016750, U01DE016752
- Acronym
- CARL
- Status last verified
- Feb 2013
- First submitted
- 24 Jan 2008
- Last updated
- 20 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
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 9670603Heaton 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
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distance Psychology for Treating Dental Fear in Rural Communities
- ClinicalTrials.gov ID
- NCT00609648
- Acronym / sponsor ID
- CARL / 30641-B
- Conditions
- Dental Anxiety
- Keywords
- Dental Anxiety, Dental Phobia, Odontophobia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- Jan 2008
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 7 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CARL | Experimental | Behavioral: Computer Assisted Relaxation LearningCARL computer program |
| Pamphlet | Active comparator | Behavioral: PamphletReassuring pamphlet about dental injections |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- High dental injection fear
- Age 18 and over
- Healthy with no untreated systemic conditions
- Able to read and write English
Key exclusion criteria (5 listed)
- Heart murmur
- Known allergies to lidocaine or benzocaine
- Under 18 year old
- Untreated systemic conditions
- Currently receiving medication for anxiety
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computer Assisted Relaxation LearningA self-paced computer program for reducing dental injection fear. | Behavioural | CARL |
| PamphletA pamphlet reassuring patients about dental injections. | Behavioural | Pamphlet |
Primary outcome
Modified Interval Scale of Anxiety Response at dental injection appointment
Time frame: One to two-weeks post-intervention/control
4 secondary outcomes
Completion of the behavioral avoidance test
Time frame: One to two-weeks post-intervention/control
Needle Survey
Time frame: Immediately post-intervention/control
Modified Dental Anxiety Scale
Time frame: Immediately post-intervention/control
Dental Fear Survey
Time frame: Immediately post-intervention/control
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2013.
- Background: PubMed 9670603Coldwell 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.
- Derived from this study: PubMed 23690352Heaton 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan E Coldwell, PhD principal investigator
University of Washington
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer Assisted Relaxation Learning and Pamphlet in people with Dental Anxiety, run by University of Washington at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Interval Scale of Anxiety Response at dental injection appointment (time frame: One to two-weeks post-intervention/control). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00609648, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2013.