Clinical Trial on Dental Anxiety - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Dental Anxiety

Detailed Description

Background: Drawings can be used as a method of communication that represents an individual's self-concept, anxiety, attitude, or conflict.

Aim: The purpose of this study was to evaluate children's drawing as a measure of dental anxiety in a dental setting.

Design: Seventy- eight children, aged 6-12 years, were enrolled in this study. Pulp therapy and/or restorative treatment was performed during the first therapeutic session for all participants. Sound, Eye, and Motor (SEM) and Frankl scales were used as an objective assessment of dental anxiety during treatment. After the treatment session, the children were instructed to draw a picture of a person at a dental clinic. Children's drawings were scored by a paediatric dentist and a psychologist using Child Drawing: Hospital (CD: H) scale and emotional indicators of Human Figure Drawings (HFD). The findings were compared with Frankl and SEM scores.

Study Type

Observational

Enrollment (Actual)

78

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Number of patients required was calculated on the basis of a micro-sample at an accepted level of significance(p<0.05) and a maximum permissible error α<0.05 and β<0.2. A total of 78 children were enrolled in this study. The participants of this study included children referred to, Paediatric Dentistry Department for their dental treatment on primary teeth. Once admitted to the Paediatric Dental Clinic children are examined by a paediatric dentist and each child is appointed for their dental therapeutic session. Comprehensive treatment plans of 571 children were examined and eligible 78 subjects who matched the inclusion criteria were randomly selected from children who were appointed for their first dental treatment session.

Description

Inclusion Criteria:

6-12 years of age-independent of sex, and ethnic characteristics
Children without previous dental treatment experience.
Children with carious primary teeth which required pulp therapy and restorative treatment
Children who are not considered medically compromised
Obtained written informed consent from parents or caregivers and obtained verbal informed consent from the child for their participance in the study where procedures are explained in an age-appropriate attitude
Children who accept to draw a picture

Exclusion Criteria:

Children with a compromised physical and mental health history
Children who already received dental treatments
Children who only needed preventive treatments
Children who reject to draw a picture

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Other
Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child Drawing: Hospital (CD: H) scale Time Frame: 1 hour	Children's drawings were scored by a paediatric dentist and a psychologist using Child Drawing: Hospital (CD: H) scale.CD: H Scoring Guide, Rating Scale and the CD: H score sheet was used for the scoring of the drawings.A manual has been established to aid in scoring the drawing, which consists of specific directions and examples to assist in scoring the drawing. Raters were directed to read and understand the CD: H manual carefully, which includes the CD: H Scoring Guide and Rating Scale and the CD: H Score Sheet.The scoring of the drawing consists of three sections. Level of anxiety according to CD: H score sheet was as follows.27 <43: very low stress, 44-83: low stress, 84-129: average stress, 130-167: above average; and 168 and over: very high stress.	1 hour
Human Figure Drawings (HFD) Time Frame: 1 hour	Children's drawings were scored by a paediatric dentist and a psychologist usingemotional indicators of Human Figure Drawings (HFD).Thirty clinically valid emotional indicators (EIs) consisting of 9 quality signs, 13 special features, and eight omissions.Drawings are analyzed by the presence or absence of EIs. Score EIs as 1 = present or 0 = absent, and a total score is achieved by adding all scores that can be used in statistical analysis. Drawings can be quickly evaluated for evidence of EIs which are signs on HFDs that are associated with specific traits, anxieties.For instance, insecure and anxious children prefer to draw small figures. Moreover, children with anxiety tend to shade parts of the figure.Two or more EIs imply possible emotional difficulties exhibited by the child that warrant further investigation.	1 hour
Frankl Scale Time Frame: 1 hour	Frankl scale was used as an objective assessment of behaviour during treatment.The Frankl scale is rated according to the following criteria: Rating score 1: definitely negative: Refusal of treatment, crying forcefully, fearful or any other overt evidence of extreme negativism; Rating score 2: negative: Reluctant to accept treatment, uncooperative, some evidence of negative attitude but not pronounced, that is sullen, withdrawn; Rating score 3: positive: acceptance of treatment; at times cautious, willingness to comply with the dentist, at times with reservation but patient follows the dentist's direction cooperatively; Rating score 4: definitely positive: good rapport with the dentist, interested in dental procedures, laughing and enjoying the situation.	1 hour
Sound, Eye, and Motor (SEM) scale Time Frame: 1 hour	Sound, Eye, and Motor (SEM) and Frankl scales were used as an objective assessment of behaviour during treatment.The slightest manifestation of the eyes, sound or motion of the patient is graded in four levels: comfort, slight discomfort, moderate pain, and pain. Rating scores range from 1 to 4. Lowest score represent comfort whereas high score indicate pain.	1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Trakya University

Collaborators

Yeditepe University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2013

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

December 25, 2019

First Submitted That Met QC Criteria

March 11, 2020

First Posted (Actual)

March 13, 2020

Study Record Updates

Last Update Posted (Actual)