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Clinical Trials/NCT01190774
NCT01190774CompletedPhase 2

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

University of St Andrews1 site in 1 country182 target enrollmentStarted: September 1, 2003Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
182
Locations
1
Primary Endpoint
State Anxiety

Study Overview

Brief 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).

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
Double (Participant, Care Provider)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •scores 19 and above on MDAS
  • •read and write English
  • •18 years of age and above

Exclusion Criteria

  • •mental illness

Arms & Interventions

Dentist behaviour

Experimental

Patient completes the MDAS which is handed to receptionist who then gives the information to the dentist with patient knowledge

Intervention: Information to health provider without patient knowledge (Behavioral)

Dentist behaviour and patient expectancy

Experimental

Patient completes the MDAS and hands to the dentist

Intervention: dentist behaviour and patient expectancy (Behavioral)

Outcomes

Primary Outcomes

State Anxiety

Time Frame: immediately after dental appointment

Speilberger's State-Trait Anxiety Inventory, short form

Secondary Outcomes

  • Discussion of dental anxiety with dentist(during appointment)

Investigators

Sponsor Class
Other

Study Sites (1)

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