NCT01190774

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
182

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2003

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2004

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2004

Completed
6 years until next milestone

First Submitted

Initial submission to the registry

August 25, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 30, 2010

Completed
Last Updated

August 30, 2010

Status Verified

July 1, 2003

Enrollment Period

7 months

First QC Date

August 25, 2010

Last Update Submit

August 27, 2010

Conditions

Keywords

dental anxietystate anxietyrandomised control trialpsychological intervention

Outcome Measures

Primary Outcomes (1)

  • State Anxiety

    Speilberger's State-Trait Anxiety Inventory, short form

    immediately after dental appointment

Secondary Outcomes (1)

  • Discussion of dental anxiety with dentist

    during appointment

Study Arms (2)

Dentist behaviour

EXPERIMENTAL

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

Dentist behaviour and patient expectancy

EXPERIMENTAL

Patient completes the MDAS and hands to the dentist

Behavioral: dentist behaviour and patient expectancy

Interventions

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

patient give information about their dental anxiety to the dentist

Dentist behaviour and patient expectancy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • mental illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Manchester

Manchester, M13 9PL, United Kingdom

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Gerald M Humphris, PhD

    University of St Andrews

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 25, 2010

First Posted

August 30, 2010

Study Start

September 1, 2003

Primary Completion

April 1, 2004

Study Completion

September 1, 2004

Last Updated

August 30, 2010

Record last verified: 2003-07

Locations