Dental AnxietyNCT02578160
Efficacy of Tell-Show-Do Behavior-Management Technique During Local Anesthesia in Preschool Children
A study testing inferior alveolar and lingual nerve block procedure in people with Dental Anxiety and Pain, run by Evelyn Alvarez Vidigal at 1 site in Brazil.
Trial summary
This will be a randomized, controlled, parallel-group clinical trial. The aim of this study will be to evaluate the effectiveness of "Tell-Show-Do" Behavior Management Technique versus a Conventional technique (covering the patient's vision) during an inferior alveolar and lingual nerve block in preschool children… Read more about this study
- Who is it for?
- Ages 36 to 71 months
- Conditions the study is for
- Dental Anxiety, Pain, Infant Behavior
- What is being tested?
- inferior alveolar and lingual nerve block procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2015to Nov 2016
- 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 36 to 71 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 1. Preschool children with severe dental caries who need dental pulp treatment and / or tooth extraction of inferior primary molars.
Who cannot join
- Preschool children with history of allergies to Lidocaine (local anesthetic)
- Preschool children with systemic or neurological diseases
- Preschool children who have received local dental anaesthesia before this study
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Faculdade de Odontologia da Universidade de Sao Paulo
São Paulo, São Paulo, 05508-000
About this study
Official title: Efficacy of Tell-Show-Do Behavior-Management Technique in Anxiety, Pain and Behavior Levels During an Inferior Alveolar and Lingual Nerve Block Procedure in Preschool Children: A Randomized Clinical Trial
This will be a randomized, controlled, parallel-group clinical trial. The aim of this study will be to evaluate the effectiveness of "Tell-Show-Do" Behavior Management Technique versus a Conventional technique (covering the patient's vision) during an inferior alveolar and lingual nerve block in preschool children referred for treatment at the School of Dentistry, University of Sao Paulo, Brazil. The sample will consist of 52 children from 3 years old to 5 years 11 months old who need dental pulp treatment and / or tooth extraction of primary molars. Preschool children with no history of allergies to Lidocaine anesthetic or systemic/neurological diseases and who did not take local anesthesia before the study will be include in this research.
Read the detailed description
Children will be randomly allocated to treatment groups (n = 26 for each group) according to the technique: (1) Tell-Show-Do and (2) Conventional. Anxiety and pain will be evaluated by the scale of Facial Image (EIF) and Wong-Baker Pain Scale, respectively. The cooperation of the patient will be evaluated by behavioral scale Frankl.
- Conditions
- Dental Anxiety, Pain, Infant Behavior, Heart Rate and Rhythm Disorders
- Being tested
- inferior alveolar and lingual nerve block procedure
- Keywords
- pain, infant behaviour, heart rate, dental anxiety
- Medical subject headings
- Pain, Infant Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inferior alveolar and lingual nerve block procedureProcedure or surgery
inferior alveolar and lingual nerve block
| Study group | Role | What they receive |
|---|---|---|
| Tell-Show-Do Behavior Technique | Experimental | This technique will involve verbal explanations related to the inferior alveolar and lingual nerve block procedure in phrases appropriate to the developmental level of the patient (tell);demonstrations for the patient of the visual, auditory, olfactory, and tactile aspects of the procedure in a carefully defined, nonthreatening setting (show); and then, without deviating from the explanation and demonstration, completion of the procedure (do). Receives: Procedure: inferior alveolar and lingual nerve block procedure |
| "Conventional Technique" | Active comparator | The operator will explain how he/she will do the inferior alveolar and lingual nerve block procedure in phrases appropriates to the child. Then quietly cover the child's field of view by hand during the inferior alveolar and lingual nerve block. Receives: Procedure: inferior alveolar and lingual nerve block procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preschool children's anxiety levels changes before and after anesthesia procedure - Facial Image Scale (FIS)
The children will be asked to point at which face they felt most like at that moment (row of five faces ranging from very happy to very unhappy - FIS)
Measured: Baseline and after one week
Secondary outcomes (5)
Preschool children's pain levels - Wong-Baker FACES Pain Scale
The children were asked to point at which face they felt most like at that moment (row of six faces ranging from very happy-does not hurt to very unhappy-hurt as much as you can imagine)
Measured: At the end of the local anesthesia procedure (2 minutes)
Preschool children's behavior - Frankl Behavioral Rating Scale
It will be evaluated children's behavior (definitely negative, negative, definitely positive, positive) during de local anesthesia procedure
Measured: Baseline and during the local anesthesia procedure (2 minutes)
Heart rates
Measured: Baseline and during local anesthesia procedure
Parent's anxiety levels - Corah's dental anxiety scale (DAS) - parent questionnaire
Measured: Baseline
family socioeconomic indicators - questionnaire related to socioeconomic conditions
questionnaire related to family socioeconomic conditions
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionOct 2016
- Study completionNov 2016 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Evelyn Alvarez Vidigal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Evelyn Alvarez Vidigal, University of Sao Paulo
- Investigators
- Marcelo Bönecker, Study director, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02578160
- Sponsor's protocol ID
- EBEMATECH
- Status last verified
- Oct 2016
- First submitted
- 12 Oct 2015
- Last updated
- 25 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: July 2016
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Tell-Show-Do Behavior-Management Technique in Anxiety, Pain and Behavior Levels During an Inferior Alveolar and Lingual Nerve Block Procedure in Preschool Children: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02578160
- Acronym / sponsor ID
- EBEMATECH
- Conditions
- Dental Anxiety, Pain, Infant Behavior, Heart Rate and Rhythm Disorders
- Keywords
- pain, infant behaviour, heart rate, dental anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Evelyn Alvarez VidigalUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Nov 2016 (estimated)
- First posted
- 16 Oct 2015 (estimated)
- 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.
This will be a randomized, controlled, parallel-group clinical trial. The aim of this study will be to evaluate the effectiveness of "Tell-Show-Do" Behavior Management Technique versus a Conventional technique (covering the patient's vision) during an inferior alveolar and lingual nerve block in preschool children referred for treatment at the School of Dentistry, University of Sao Paulo, Brazil. The sample will consist of 52 children from 3 years old to 5 years 11 months old who need dental pulp treatment and / or tooth extraction of primary molars. Preschool children with no history of allergies to Lidocaine anesthetic or systemic/neurological diseases and who did not take local anesthesia before the study will be include in this research.
Detailed description
Children will be randomly allocated to treatment groups (n = 26 for each group) according to the technique: (1) Tell-Show-Do and (2) Conventional. Anxiety and pain will be evaluated by the scale of Facial Image (EIF) and Wong-Baker Pain Scale, respectively. The cooperation of the patient will be evaluated by behavioral scale Frankl.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tell-Show-Do Behavior Technique | Experimental | Procedure: inferior alveolar and lingual nerve block procedureThis technique will involve verbal explanations related to the inferior alveolar and lingual nerve block procedure in phrases appropriate to the developmental level of the patient (tell);demonstrations for the patient of the visual, auditory, olfactory, and tactile aspects of the procedure in a carefully defined, nonthreatening setting (show); and then, without deviating from the explanation and demonstration, completion of the procedure (do). |
| "Conventional Technique" | Active comparator | Procedure: inferior alveolar and lingual nerve block procedureThe operator will explain how he/she will do the inferior alveolar and lingual nerve block procedure in phrases appropriates to the child. Then quietly cover the child's field of view by hand during the inferior alveolar and lingual nerve block. |
Who may qualify
- Ages
- 36 to 71 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 1. Preschool children with severe dental caries who need dental pulp treatment and / or tooth extraction of inferior primary molars.
Key exclusion criteria (3 listed)
- Preschool children with history of allergies to Lidocaine (local anesthetic)
- Preschool children with systemic or neurological diseases
- Preschool children who have received local dental anaesthesia before this study
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 |
|---|---|---|
| inferior alveolar and lingual nerve block procedureinferior alveolar and lingual nerve block | Procedure or surgery | "Conventional Technique", Tell-Show-Do Behavior Technique |
Primary outcome
Preschool children's anxiety levels changes before and after anesthesia procedure - Facial Image Scale (FIS)
Time frame: Baseline and after one week
The children will be asked to point at which face they felt most like at that moment (row of five faces ranging from very happy to very unhappy - FIS)
5 secondary outcomes
Preschool children's pain levels - Wong-Baker FACES Pain Scale
Time frame: At the end of the local anesthesia procedure (2 minutes)
Preschool children's behavior - Frankl Behavioral Rating Scale
Time frame: Baseline and during the local anesthesia procedure (2 minutes)
Heart rates
Time frame: Baseline and during local anesthesia procedure
Parent's anxiety levels - Corah's dental anxiety scale (DAS) - parent questionnaire
Time frame: Baseline
family socioeconomic indicators - questionnaire related to socioeconomic conditions
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2016.
- Individual participant dataSharing planned: Yes. July 2016
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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.
Marcelo Bönecker study director
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing inferior alveolar and lingual nerve block procedure in people with Dental Anxiety and Pain, run by Evelyn Alvarez Vidigal at 1 site in Brazil.
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 3 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: status not confirmed, as of the sponsor's last update on 25 Oct 2016. 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 Brazil. 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?
Results are not available in the source record.
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?
Preschool children's anxiety levels changes before and after anesthesia procedure - Facial Image Scale (FIS) (time frame: Baseline and after one week). 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 25 Oct 2016.