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Anxiety Assessment Intervention in Dental Patients (ANXDEN)

Primary Purpose

Anxiety State

Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Information to health provider without patient knowledge
dentist behaviour and patient expectancy
Sponsored by
University of St Andrews
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Anxiety State focused on measuring dental anxiety, state anxiety, randomised control trial, psychological intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • mental illness

Sites / Locations

  • University of Manchester

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Dentist behaviour

Dentist behaviour and patient expectancy

Arm Description

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

Patient completes the MDAS and hands to the dentist

Outcomes

Primary Outcome Measures

State Anxiety
Speilberger's State-Trait Anxiety Inventory, short form

Secondary Outcome Measures

Discussion of dental anxiety with dentist
Simple 'yes' 'no' dichotomy

Full Information

First Posted
August 25, 2010
Last Updated
August 27, 2010
Sponsor
University of St Andrews
Collaborators
University of Manchester
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1. Study Identification

Unique Protocol Identification Number
NCT01190774
Brief Title
Anxiety Assessment Intervention in Dental Patients
Acronym
ANXDEN
Official Title
An Investigation Into Patients' State Anxiety Reduction Following the Administration of a Dental Anxiety Questionnaire in the Dental Treatment Setting
Study Type
Interventional

2. Study Status

Record Verification Date
July 2003
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
April 2004 (Actual)
Study Completion Date
September 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of St Andrews
Collaborators
University of Manchester

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety State
Keywords
dental anxiety, state anxiety, randomised control trial, psychological intervention

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
182 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dentist behaviour
Arm Type
Experimental
Arm Description
Patient completes the MDAS which is handed to receptionist who then gives the information to the dentist with patient knowledge
Arm Title
Dentist behaviour and patient expectancy
Arm Type
Experimental
Arm Description
Patient completes the MDAS and hands to the dentist
Intervention Type
Behavioral
Intervention Name(s)
Information to health provider without patient knowledge
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
dentist behaviour and patient expectancy
Intervention Description
patient give information about their dental anxiety to the dentist
Primary Outcome Measure Information:
Title
State Anxiety
Description
Speilberger's State-Trait Anxiety Inventory, short form
Time Frame
immediately after dental appointment
Secondary Outcome Measure Information:
Title
Discussion of dental anxiety with dentist
Description
Simple 'yes' 'no' dichotomy
Time Frame
during appointment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: scores 19 and above on MDAS read and write English 18 years of age and above Exclusion Criteria: mental illness
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerald M Humphris, PhD
Organizational Affiliation
University of St Andrews
Official's Role
Study Director
Facility Information:
Facility Name
University of Manchester
City
Manchester
ZIP/Postal Code
M13 9PL
Country
United Kingdom

12. IPD Sharing Statement

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Anxiety Assessment Intervention in Dental Patients

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