Anxiety Assessment Intervention in Dental Patients (ANXDEN)

This study has been completed.
Sponsor:
Collaborator:
University of Manchester
Information provided by:
University of St Andrews
ClinicalTrials.gov Identifier:
NCT01190774
First received: August 25, 2010
Last updated: August 27, 2010
Last verified: July 2003
  Purpose

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).


Condition Intervention Phase
Anxiety State
Behavioral: Information to health provider without patient knowledge
Behavioral: dentist behaviour and patient expectancy
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Health Services Research
Official Title: An Investigation Into Patients' State Anxiety Reduction Following the Administration of a Dental Anxiety Questionnaire in the Dental Treatment Setting

Resource links provided by NLM:


Further study details as provided by University of St Andrews:

Primary Outcome Measures:
  • State Anxiety [ Time Frame: immediately after dental appointment ] [ Designated as safety issue: No ]
    Speilberger's State-Trait Anxiety Inventory, short form


Secondary Outcome Measures:
  • Discussion of dental anxiety with dentist [ Time Frame: during appointment ] [ Designated as safety issue: No ]
    Simple 'yes' 'no' dichotomy


Enrollment: 182
Study Start Date: September 2003
Study Completion Date: September 2004
Primary Completion Date: April 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dentist behaviour
Patient completes the MDAS which is handed to receptionist who then gives the information to the dentist with patient knowledge
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
Experimental: Dentist behaviour and patient expectancy
Patient completes the MDAS and hands to the dentist
Behavioral: dentist behaviour and patient expectancy
patient give information about their dental anxiety to the dentist

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • mental illness
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01190774

Locations
United Kingdom
University of Manchester
Manchester, United Kingdom, M13 9PL
Sponsors and Collaborators
University of St Andrews
University of Manchester
Investigators
Study Director: Gerald M Humphris, PhD University of St Andrews
  More Information

No publications provided

Responsible Party: Professor Nick Tarrier, University of Manchester
ClinicalTrials.gov Identifier: NCT01190774     History of Changes
Other Study ID Numbers: Denanx0103
Study First Received: August 25, 2010
Last Updated: August 27, 2010
Health Authority: United Kingdom: National Health Service

Keywords provided by University of St Andrews:
dental anxiety
state anxiety
randomised control trial
psychological intervention

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on October 19, 2014