- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01190774
Anxiety Assessment Intervention in Dental Patients (ANXDEN)
An Investigation Into Patients' State Anxiety Reduction Following the Administration of a Dental Anxiety Questionnaire in the Dental Treatment Setting
Dental anxiety is a significant barrier to the acceptance of regular dental care, and has many negative consequences. A study by Dailey et al. (2002) found that providing the dentist with information of the high level of a patient's dental anxiety prior to treatment using the Modified Dental Anxiety Scale (MDAS, Humphris et al., 1995), lead to a significant reduction in state anxiety from pre- to post- dental consultation compared to a control group. The current study aimed to replicate the study by Dailey et al. (2002), and to further explore whether the reduction in state anxiety associated with the MDAS could be explained by a change in dentist behaviour on receiving it, or a change in patient expectancy about the treatment session, or both.
The design was a randomised control trial involving three groups, which aimed to manipulate possible changes in dentist behaviour and patient expectancy. In Group 1, the MDAS was left at reception, as expected by the patient. In Group 2, the dentist received the MDAS, although the patient did not expect this. In Group 3 the dentist received the MDAS and the patient did expect this. The sample (N=182) was taken from two dental access centres, and included participants obtaining a score of 19 or above, or 5 on any one item of the MDAS. Pre- and post-dental consultation measures of state anxiety were taken using the six-item short-form of the state scale of the Spielberger State-Trait Anxiety Inventory (STAI-S, Marteau & Bekker, 1992).
Study Overview
Status
Conditions
Detailed Description
The aim of the current study was to compare the degree of anxiety reduction in dentally anxious patients attending a Dental Access Center where the dentist did or did not receive the patients' assessment of dental anxiety.
METHODS Design of study A three group pre-and post-test design was adopted, a control group (Group1: patient completed the MDAS (Modified Dental Anxiety Scale) questionnaire and handed it to the receptionist) and the experimental group where the patient handed the MDAS to the dentist (Group 3). An additional group was included (Group 2). Patients completed the MDAS and handed it to the receptionist whereupon it was given to the dentist contrary to patient expectation. The dental staff were kept blind to the actual design of the study. The Local Research and Ethics Committee approved the study.
Test the hypothesis that patients sharing assessment information about their dental anxiety to members of the dental team has beneficial effects on their state anxiety.
Randomisation A block randomisation schedule was computer generated by University of Manchester statistician (BT). Pre-sealed opaque envelopes that contained questionnaires specific to the three groups were prepared by a colleague to minimise selection bias. All materials were pre-coded with the participant number.
Sample
Dental Access Centers provide: general dental services to those who are not registered with a NHS dentist, NHS patient charges and receipt of easily available treatment and advice (appointment not always necessary). The study was conducted at two Greater Manchester Dental Access Centers. These sites offered treatment to emergency dental patients who were more likely to become dentally anxious than regular attenders (Maggirias and Locker, 2002) . Participants were volunteers recruited, from October 2003 to April 2004.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Manchester, United Kingdom, M13 9PL
- University of Manchester
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- scores 19 and above on MDAS
- read and write English
- 18 years of age and above
Exclusion Criteria:
- mental illness
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Dentist behaviour
Patient completes the MDAS which is handed to receptionist who then gives the information to the dentist with patient knowledge
|
The intervention consists of the assessment information from the MDAS questionnaire being given to the dentist via the receptionist without the knowledge of the patient
|
|
Experimental: Dentist behaviour and patient expectancy
Patient completes the MDAS and hands to the dentist
|
patient give information about their dental anxiety to the dentist
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
State Anxiety
Time Frame: immediately after dental appointment
|
Speilberger's State-Trait Anxiety Inventory, short form
|
immediately after dental appointment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Discussion of dental anxiety with dentist
Time Frame: during appointment
|
Simple 'yes' 'no' dichotomy
|
during appointment
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Gerald M Humphris, PhD, University of St Andrews
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Denanx0103
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