Anxiety Assessment Intervention in Dental Patients

Anxiety State Clinical Trial

— ANXDEN  

Official title:

An Investigation Into Patients' State Anxiety Reduction Following the Administration of a Dental Anxiety Questionnaire in the Dental Treatment Setting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01190774
• Other study ID #: Denanx0103
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: August 25, 2010
• Last updated: August 27, 2010
• Start date: September 2003
• Est. completion date: September 2004

Study information

• Verified date: July 2003
• Source: University of St Andrews
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: September 2004
• Est. primary completion date: April 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• scores 19 and above on MDAS

• read and write English

• 18 years of age and above

Exclusion Criteria:

• mental illness

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Anxiety Disorders
• Anxiety State

Intervention

Behavioral:
• Information to health provider without 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
• dentist behaviour and patient expectancy
patient give information about their dental anxiety to the dentist

Locations

Country	Name	City	State
United Kingdom	University of Manchester	Manchester

Sponsors (2)

Lead Sponsor	Collaborator
University of St Andrews	University of Manchester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	State Anxiety	Speilberger's State-Trait Anxiety Inventory, short form	immediately after dental appointment	No
Secondary	Discussion of dental anxiety with dentist	Simple 'yes' 'no' dichotomy	during appointment	No