Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02081365
Other study ID # 4100054871
Secondary ID
Status Completed
Phase N/A
First received December 17, 2013
Last updated July 29, 2015
Start date July 2013
Est. completion date December 2014

Study information

Verified date July 2015
Source Temple University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Dental and health anxiety are common and potentially distressing problems, for both patients and health care providers. Anxiety has been identified as a barrier to regular dental visits and as an important target for enhancement of oral health-related quality of life. The goal of this project is to develop a computer-administered dental anxiety management program that can easily be implemented in dental health care settings. Our aim is for this management program to: 1) integrate different treatments modalities such as cognitive-behavioral therapy (CBT) and motivational interviewing (MI) into one computer-based protocol; 2) facilitate patient adherence to this protocol; 3) lend itself to empirical validation; and 4) lend itself to dissemination to other research and treatment settings. A randomized controlled trial (RCT) will be conducted (n=200). Based on the subjects responses to the screening questionnaires, consenting dental patients at Temple University Kornberg School of Dentistry will be assigned to one of 2 possible groups, (1) high dental anxiety and (2) low dental anxiety. The intervention package will be delivered to a randomly selected half of participants in group 1 (high anxiety group), whereas the remaining participants in this group will be assigned to a delayed treatment control condition. The low dental anxiety patients (group 2) will be used as a benchmark against which to compare post-treatment (or post-control) outcomes for the high anxiety patients. We hope to develop an intervention that can be easily implemented in a broader context without the need for highly specialized personnel.


Recruitment information / eligibility

Status Completed
Enrollment 151
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- high dental anxiety

- fluent in spoken and written English

Exclusion Criteria:

- unable to provide written, informed consent

Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Computerized Dental Anxiety Treatment
The Computerized Dental Anxiety Treatment Program consists of treatment modules that are be delivered through a computer. The modules use Cognitive Behavioral Therapy (CBT) to assist the participant in preparing a personal plan for managing his/her dental anxiety. The program incorporates a range of CBT techniques, including cognitive restructuring, exposure, and motivational interviewing.

Locations

Country Name City State
United States Temple University Kornberg School of Dentistry Philadelphia Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
Temple University Pennsylvania Department of Health

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Modified Dental Anxiety Scale Change from one week before intervention to 1 month after intervention No
Primary Change in Anxiety Disorders Interview Schedule for DSM-IV Change from one week before intervention to one-month after intervention No
See also
  Status Clinical Trial Phase
Completed NCT06385314 - A Cross Sectional Study on Dental Anxiety and State Anxiety Related to Removal of Fixed Partial Dentures
Completed NCT04308005 - Drawing as a Measurement of Dental Anxiety
Completed NCT01908127 - Efficacy of Film Modelling in Paediatric Dentistry N/A
Completed NCT00695630 - Flumazenil Reversal of Oral Triazolam Phase 1/Phase 2
Completed NCT05759286 - A Blend of Lavender-neroli Oils Aromatherapy and Music for Managing Anxiety in a Pediatric Patient N/A
Completed NCT04234737 - Efficacy of Hypnotherapy in Children With Dental Anxiety N/A
Completed NCT03838081 - Evaluation on the Anxiety of Third Molar Extraction N/A
Enrolling by invitation NCT06057090 - Do Therapy Dogs Improve Behavior and Reduce Anxiety in Pediatric Dental Patients? N/A
Not yet recruiting NCT04924452 - Er:YAG Laser Therapy in Combination With Behaviour Management Technique in Reducing Anxiety Among Paediatric Patients N/A
Completed NCT03596255 - Clinical Estimation of Dental Anxiety
Completed NCT03722771 - Influence of Lavender Oil on Vital Signs in Oral Surgery Patients N/A
Completed NCT05038540 - The Effect of Virtual Reality Glasses on Dental Anxiety Control N/A
Completed NCT03324347 - Dog-Assisted Therapy in Dentistry N/A
Not yet recruiting NCT06139640 - The Effect of Damask Rose Essential Oil Aromatherapy on Dental Anxiety and Pain on Children N/A
Completed NCT02588079 - Internet-Based Cognitive Behavioral Therapy for Children With Dental Anxiety N/A
Completed NCT02591797 - Effectiveness of Hand/Eyes/Mouth Behavior Management Technique During Local Anesthesia in Preschool Children N/A
Not yet recruiting NCT00355693 - Effect Site Controlled, Reaction Time Safeguarded, Patient Maintained Sedation With Propofol in Anxious Patients Phase 4
Recruiting NCT06243705 - Effectiveness of Robot-pets in Reducing Dental Anxiety in Children N/A
Recruiting NCT06058533 - Pre-Visit Positive Imagery in Reducing Dental Anxiety N/A
Completed NCT03993080 - Virtual Reality Relaxation to Decrease Dental Anxiety N/A