Dental AnxietyNCT04308005
Drawing as a Measurement of Dental Anxiety
An observational study of Dental Anxiety, run by Trakya University.
Trial summary
In the present study, we aimed to assess children's anxiety levels by using different dental anxiety scales and children's drawings evaluated according to two different scoring systems: Child Drawing: Hospital (CD: H) and Emotional indicators of Human Figure Drawings (HFD). Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety
- How many people
- 78 participants
- Where
- No sites listed yet
- Study dates
- Sep 2013to Oct 2015
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Children's Drawing as a Measurement of Dental Anxiety in Paediatric Dentistry
In the present study, we aimed to assess children's anxiety levels by using different dental anxiety scales and children's drawings evaluated according to two different scoring systems: Child Drawing: Hospital (CD: H) and Emotional indicators of Human Figure Drawings (HFD).
Read the 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.
- Conditions
- Dental Anxiety
- Keywords
- Drawing, Children, Dental Anxiety
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Drawing: Hospital (CD: H) scale
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.
Measured: 1 hour
Human Figure Drawings (HFD)
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.
Measured: 1 hour
Frankl Scale
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.
Measured: 1 hour
Sound, Eye, and Motor (SEM) scale
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.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2020
- Study startSep 2013
- Primary completionJun 2014
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 78 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Collaborators
- Yeditepe University
- Responsible party
- Principal investigator, ŞİRİN GÜNER ONUR, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04308005
- Sponsor's protocol ID
- SONUR
- Status last verified
- Mar 2020
- First submitted
- 25 Dec 2019
- Last updated
- 13 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Children's Drawing as a Measurement of Dental Anxiety in Paediatric Dentistry
- ClinicalTrials.gov ID
- NCT04308005
- Acronym / sponsor ID
- SONUR
- Conditions
- Dental Anxiety
- Keywords
- Drawing, Children, Dental Anxiety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Collaborators
- Yeditepe University
- Study start
- Sep 2013 (actual)
- Primary completion
- Jun 2014 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 13 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In the present study, we aimed to assess children's anxiety levels by using different dental anxiety scales and children's drawings evaluated according to two different scoring systems: Child Drawing: Hospital (CD: H) and Emotional indicators of Human Figure Drawings (HFD).
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Anxiety, run by Trakya University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child Drawing: Hospital (CD: H) scale (time frame: 1 hour). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2020.