Behavior, ChildPREPNCT05608720
Preparation Protocol for the First Pediatric Dental Visit
A study testing Information Booklet in people with Behavior, Child and Dentist-Patient Relations, run by University of Bologna at 1 site in Italy.
Trial summary
To date, not enough attention has been paid to the role of communication before the first dental visit to encourage the child's cooperation and avoid dysfunctional behaviors. The dentist can provide parents with the information they need to adequately prepare the child for treatment. Read more about this study
- Who is it for?
- Ages 4 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Behavior, Child, Dentist-Patient Relations
- What is being tested?
- Information Booklet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2019to 1 Oct 2019
- Phase
- Interventional
- 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 4 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- child requiring a first dental visit
Who cannot join
- previous dental visits, intellectual disability, mother tongue other than Italian, una-vailable e-mail address
Trial locations and contacts
1 site in 1 country.
Italy1 site
Servizio di Assistenza Odontoiatrica per disabili in età evolutiva e di odontoiatria infantile
Bologna, 40125
About this study
Official title: Randomized Clinical Trial to Test a Preparation Protocol for the First Pediatric Dental Visit.
To date, not enough attention has been paid to the role of communication before the first dental visit to encourage the child's cooperation and avoid dysfunctional behaviors. The dentist can provide parents with the information they need to adequately prepare the child for treatment. The present study aims to investigate the effectiveness of an infor-mation booklet to promote pediatric patients' cooperation during the first dental visit
Read the detailed description
The aim of the study was to test an Information Booklet preparing the child to the first dental vis-it. Forty-five children and one parent per included child took part in the trial. Children were ran-domized in two groups: the Information Booklet was e-mailed to the parents of the study group. At the end of the visit, the dentist and the parent evaluated the child's behavior through the Frankl Behavior Rating Scale (FBRS) and the utility of the Booklet through a Likert scale. The children evaluated the pleasantness of the visit and the perceived pain through the Wong-Baker FACES® Pain Rating Scale (WBFPRS).
- Conditions
- Behavior, Child, Dentist-Patient Relations
- Being tested
- Information Booklet
- Keywords
- behavior management, first dental visit
- Medical subject headings
- Child Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Information BookletBehavioural
Information Booklet prior to the dental visit
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | Information Booklet prior to the dental visit Receives: Behavioral: Information Booklet |
| control group | No intervention | no information prior to the dental visit |
What is being measured
The primary outcome is the main question the study is designed to answer.
child's behavior assessed by dentist with the Frankl Behavior Rating Scale (FBRS)
FBRS: values from 1 (Definitely negative) to 4 (definitely positive)
Measured: immediately after the intervention
Secondary outcomes (1)
self reported pain assessed by the Wong Baker faces pain rating scale (WBFPRS)
WBFPRS: from 0 (no hurt) to 10 (hurts worst)
Measured: immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
- Study start1 Jan 2019
- Primary completion1 Sep 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavior, ChildStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simone Bagattoni, University of Bologna
- Investigators
- Simone Bagattoni, Principal investigator, Bologna University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05608720
- Sponsor's protocol ID
- bagattoni1
- Acronym
- PREP
- Status last verified
- Nov 2022
- First submitted
- 27 Oct 2022
- Last updated
- 8 Nov 2022
- Results posted
- 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 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial to Test a Preparation Protocol for the First Pediatric Dental Visit.
- ClinicalTrials.gov ID
- NCT05608720
- Acronym / sponsor ID
- PREP / bagattoni1
- Conditions
- Behavior, Child, Dentist-Patient Relations
- Keywords
- behavior management, first dental visit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 8 Nov 2022 (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.
To date, not enough attention has been paid to the role of communication before the first dental visit to encourage the child's cooperation and avoid dysfunctional behaviors. The dentist can provide parents with the information they need to adequately prepare the child for treatment. The present study aims to investigate the effectiveness of an infor-mation booklet to promote pediatric patients' cooperation during the first dental visit
Detailed description
The aim of the study was to test an Information Booklet preparing the child to the first dental vis-it. Forty-five children and one parent per included child took part in the trial. Children were ran-domized in two groups: the Information Booklet was e-mailed to the parents of the study group. At the end of the visit, the dentist and the parent evaluated the child's behavior through the Frankl Behavior Rating Scale (FBRS) and the utility of the Booklet through a Likert scale. The children evaluated the pleasantness of the visit and the perceived pain through the Wong-Baker FACES® Pain Rating Scale (WBFPRS).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Behavioral: Information BookletInformation Booklet prior to the dental visit |
| control group | No intervention | –no information prior to the dental visit |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- child requiring a first dental visit
Key exclusion criteria (1 listed)
- previous dental visits, intellectual disability, mother tongue other than Italian, una-vailable e-mail address
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Information BookletInformation Booklet prior to the dental visit | Behavioural | study group |
Primary outcome
child's behavior assessed by dentist with the Frankl Behavior Rating Scale (FBRS)
Time frame: immediately after the intervention
FBRS: values from 1 (Definitely negative) to 4 (definitely positive)
1 secondary outcome
self reported pain assessed by the Wong Baker faces pain rating scale (WBFPRS)
Time frame: immediately after the intervention
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 8 Nov 2022.
- Individual participant dataSharing planned: No
Related trials for Behavior, Child
RecruitingObservational study
Psychotherapy for Irritability in Youth: Comparing Active Treatment to Nonactive Psychoeducation Supportive Psychotherapy
Irritability, Disruptive Mood Dysregulation Disorder
Active, not recruiting
Chicago Parent Program for Foster and Kinship Caregivers
Behavior Problem, Parenting
Active, not recruiting
Tailoring CPP for the Foster Care Setting
Behavior Problem
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
Active, not recruiting
Improving Student Mental Health Through a Universal Trauma-Informed Intervention
Anxiety Symptoms, Post-traumatic Stress Symptoms
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.
Simone Bagattoni principal investigator
Bologna University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Information Booklet in people with Behavior, Child and Dentist-Patient Relations, run by University of Bologna at 1 site in Italy.
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 1 inclusion and 1 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 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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's behavior assessed by dentist with the Frankl Behavior Rating Scale (FBRS) (time frame: immediately after the intervention). 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 8 Nov 2022.