Behavior, ChildNCT06122883
Dental Attire Effect on Children's Dental Anxiety
A study testing Evaluation the effectiveness of distraction in the reception area in the management of anxious pediatric patients during dental local anesthesia, Evaluation the effectiveness of distraction in the treatment area in the management of anxious pediatric patients during dental local anesthesia and Evaluation the effectiveness of distraction in both reception and treatment areas in the management of anxious pediatric patients during dental local anesthesia in people with Behavior, Child and Dental Anxiety, run by Damascus University at 1 site in Syria.
Trial summary
The aim of this study is to evaluate the effect of friendly attire on dental anxiety among children visiting dental office in comparison with conventional attire. All of the children who will be experienced maxillary dental anesthesia with/without distraction will be assessed by using a combination of measures… Read more about this study
- Who is it for?
- Ages 6 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Behavior, Child, Dental Anxiety, Anesthesia, Local
- What is being tested?
- Evaluation the effectiveness of distraction in the reception area in the management of anxious pediatric patients during dental local anesthesia, Evaluation the effectiveness of distraction in the treatment area in the management of anxious pediatric patients during dental local anesthesia and Evaluation the effectiveness of distraction in both reception and treatment areas in the management of anxious pediatric patients during dental local anesthesia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSyria
- Study dates
- 15 Jan 2023to 25 May 2024
- 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 6 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age between 6 and 10 years.
- No previous dental experience.
- Definitely positive or positive according to Frank scale.
- Need of maxillary anesthesia for any dental treatment.
Who cannot join
- Previous dental experience
- Systematic or mental disorders.
- Definitely negative or negative according to Frankel scale
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Official Title Evaluating the Effect of Dentist's Attire on Children's Acceptance of Dental Treatment Including Local Anesthesia
The aim of this study is to evaluate the effect of friendly attire on dental anxiety among children visiting dental office in comparison with conventional attire. All of the children who will be experienced maxillary dental anesthesia with/without distraction will be assessed by using a combination of measures: Wong-Baker faces and the Children's Fear Scale (self-report), heart pulse rate, and behavior (using Anxiety levels using Face - Legs - Activity - Cry - Consolability "FLACC" scale "external evaluator") Acceptance will be measured using a two-point Likert scale.
Read the detailed description
This study will evaluate the effect of dental attire on children's acceptance of different dental treatments that include dental anesthesia. pain and anxiety will be evaluated during buccal and palatal infiltration using five behavioral scales, Wong-Baker pain scale, Children's Fear Scale and Children's Anxiety Questionnaire (self-report), pulse rate (physiological) and behavior (using FLACC behavior rating scale "external evaluator".
Heart pulse rate measurement will be recorded firstly when the patient is seated comfortably in the reception area, on dental chair prior to the injection, and finally after the procedure is done and the child patients will be asked to choose a face that describe their status from one of both Wong Baker faces scale, Children's Fear Scale and Children's Anxiety Questionnaire.
Body responses of all child patients will be recorded during the whole procedure and then will be evaluated by an external evaluator to determine the children behavioral score according to FLACC scale.
- Conditions
- Behavior, Child, Dental Anxiety, Anesthesia, Local
- Being tested
- Evaluation the effectiveness of distraction in the reception area in the management of anxious pediatric patients during dental local anesthesia, Evaluation the effectiveness of distraction in the treatment area in the management of anxious pediatric patients during dental local anesthesia, Evaluation the effectiveness of distraction in both reception and treatment areas in the management of anxious pediatric patients during dental local anesthesia, Evaluation of the effectiveness of basic behavior guidance techniques without using any type of distraction aids in the management of anxious pediatric patients during dental local anesthesia
- Keywords
- Dental attire, Behavior management, Children fear
- Medical subject headings
- Child Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation the effectiveness of distraction in the reception area in the management of anxious pediatric patients during dental local anesthesiaBehavioural
Buccal and palatal infiltration will be administrated with basic behavior guidance techniques while the dentist wearing conventional attire in the treatment room after meeting the child in the reception area while wearing the friendly attire.
Evaluation the effectiveness of distraction in the treatment area in the management of anxious pediatric patients during dental local anesthesiaBehavioural
Buccal and palatal infiltration will be administrated with basic behavior guidance techniques while the dentist wearing friendly attire in the treatment room after meeting the child in the reception area while wearing the conventional attire.
Evaluation the effectiveness of distraction in both reception and treatment areas in the management of anxious pediatric patients during dental local anesthesiaBehavioural
Buccal and palatal infiltration will be administrated with basic behavior guidance techniques while the dentist wearing friendly attire in the reception area and treatment room.
Evaluation of the effectiveness of basic behavior guidance techniques without using any type of distraction aids in the management of anxious pediatric patients during dental local anesthesiaBehavioural
Buccal and palatal infiltration will be administrated with basic behavior guidance techniques while the dentist wearing conventional attire in the reception area and treatment room.
| Study group | Role | What they receive |
|---|---|---|
| Distraction in the reception area. | Experimental | Not described Receives: Behavioral: Evaluation the effectiveness of distraction in the reception area in the management of anxious pediatric patients during dental local anesthesia |
| Distraction in the treatment area. | Experimental | Not described Receives: Behavioral: Evaluation the effectiveness of distraction in the treatment area in the management of anxious pediatric patients during dental local anesthesia |
| Distraction in both treatment and reception area. | Experimental | Not described Receives: Behavioral: Evaluation the effectiveness of distraction in both reception and treatment areas in the management of anxious pediatric patients during dental local anesthesia |
| Basic behavior guidance techniques without using any type of distraction aids. | Other | Not described Receives: Behavioral: Evaluation of the effectiveness of basic behavior guidance techniques without using any type of distraction aids in the management of anxious pediatric patients during dental local anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain levels
Pain levels will be measured by using a self-reported simplified Wong-Baker faces pain scale:
0 no Hurt - 1 Hurts little Bit - 2 Hurts little More - 3 Hurts Even More - 4 Hurts Whole Lot - 5 Hurts Worst
Measured: 5 minutes following the dental local anesthesia.
Anxiety levels
This will be evaluated using the Face-Legs-Activity-Cry-Consolability (FLACC) scale (0 low anxiety and pain level - 10 high anxiety and pain level).
Measured: 1 minute during the dental local anesthesia.
Anxiety levels
This will be evaluated using Children's Fear Scale (0 indicating 'no anxiety' and 4 indicating 'extreme anxiety') and Children Anxiety Questionnaire (self-report) (4 indicating 'no anxiety' and 16 indicating 'extreme anxiety').
Measured: 5 minutes following the meeting with the dentist in the reception area, and 5 minutes after the patient is seated comfortably on the dental chair
Pulse rate
Pulse rate (the number of times your heart beats each minute bpm will be evaluated using Finger Pulse Oximeter.
Measured: (1) five minutes after the patient is seated comfortably in the reception area, (2) five minutes after the patient is seated comfortably on the dental chair, (3) five minutes following the injection of the anesthetic drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start15 Jan 2023
- Primary completion15 Dec 2023
- Study completion25 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jamila Bchara, DDs, Principal investigator, Damascus UniversityMohannad Laflof, Phd, Study director, Damascus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06122883
- Sponsor's protocol ID
- UDDS-Pedo-10-2023
- Status last verified
- Jul 2024
- First submitted
- 3 Nov 2023
- Last updated
- 9 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kastelic DR, Volpato LE, de Campos Neves AT, Aranha AM, Martins CC. Do Children and Adolescents Prefer Pediatric Attire over White Attire during Dental Appointments? A Meta-analysis of Prevalence Data. Int J Clin Pediatr Dent. 2021 Jan-Feb;14(1):14-29. doi: 10.5005/jp-journals-10005-1861.
PubMed 34326579Kamavaram Ellore VP, Mohammed M, Taranath M, Ramagoni NK, Kumar V, Gunjalli G. Children and Parent's Attitude and Preferences of Dentist's Attire in Pediatric Dental Practice. Int J Clin Pediatr Dent. 2015 May-Aug;8(2):102-7. doi: 10.5005/jp-journals-10005-1293. Epub 2015 Aug 11.
PubMed 26379376Festini F, Occhipinti V, Cocco M, Biermann K, Neri S, Giannini C, Galici V, de Martino M, Caprilli S. Use of non-conventional nurses' attire in a paediatric hospital: a quasi-experimental study. J Clin Nurs. 2009 Apr;18(7):1018-26. doi: 10.1111/j.1365-2702.2008.02430.x.
PubMed 19284436Babaji P, Chauhan PP, Rathod V, Mhatre S, Paul U, Guram G. Evaluation of child preference for dentist attire and usage of camouflage syringe in reduction of anxiety. Eur J Dent. 2017 Oct-Dec;11(4):531-536. doi: 10.4103/ejd.ejd_223_17.
PubMed 29279683Dionigi A, Sangiorgi D, Flangini R. Clown intervention to reduce preoperative anxiety in children and parents: a randomized controlled trial. J Health Psychol. 2014 Mar;19(3):369-80. doi: 10.1177/1359105312471567. Epub 2013 Jan 29.
PubMed 23362335Manyande A, Cyna AM, Yip P, Chooi C, Middleton P. Non-pharmacological interventions for assisting the induction of anaesthesia in children. Cochrane Database Syst Rev. 2015 Jul 14;2015(7):CD006447. doi: 10.1002/14651858.CD006447.pub3.
PubMed 26171895
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Official Title Evaluating the Effect of Dentist's Attire on Children's Acceptance of Dental Treatment Including Local Anesthesia
- ClinicalTrials.gov ID
- NCT06122883
- Acronym / sponsor ID
- UDDS-Pedo-10-2023
- Conditions
- Behavior, Child, Dental Anxiety, Anesthesia, Local
- Keywords
- Dental attire, Behavior management, Children fear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 15 Jan 2023 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 25 May 2024 (actual)
- First posted
- 8 Nov 2023 (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.
The aim of this study is to evaluate the effect of friendly attire on dental anxiety among children visiting dental office in comparison with conventional attire. All of the children who will be experienced maxillary dental anesthesia with/without distraction will be assessed by using a combination of measures: Wong-Baker faces and the Children's Fear Scale (self-report), heart pulse rate, and behavior (using Anxiety levels using Face - Legs - Activity - Cry - Consolability "FLACC" scale "external evaluator") Acceptance will be measured using a two-point Likert scale.
Detailed description
This study will evaluate the effect of dental attire on children's acceptance of different dental treatments that include dental anesthesia. pain and anxiety will be evaluated during buccal and palatal infiltration using five behavioral scales, Wong-Baker pain scale, Children's Fear Scale and Children's Anxiety Questionnaire (self-report), pulse rate (physiological) and behavior (using FLACC behavior rating scale "external evaluator".
Heart pulse rate measurement will be recorded firstly when the patient is seated comfortably in the reception area, on dental chair prior to the injection, and finally after the procedure is done and the child patients will be asked to choose a face that describe their status from one of both Wong Baker faces scale, Children's Fear Scale and Children's Anxiety Questionnaire.
Body responses of all child patients will be recorded during the whole procedure and then will be evaluated by an external evaluator to determine the children behavioral score according to FLACC scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Distraction in the reception area. | Experimental | Behavioral: Evaluation the effectiveness of distraction in the reception area in the management of anxious pediatric patients during dental local anesthesia |
| Distraction in the treatment area. | Experimental | Behavioral: Evaluation the effectiveness of distraction in the treatment area in the management of anxious pediatric patients during dental local anesthesia |
| Distraction in both treatment and reception area. | Experimental | Behavioral: Evaluation the effectiveness of distraction in both reception and treatment areas in the management of anxious pediatric patients during dental local anesthesia |
| Basic behavior guidance techniques without using any type of distraction aids. | Other | Behavioral: Evaluation of the effectiveness of basic behavior guidance techniques without using any type of distraction aids in the management of anxious pediatric patients during dental local anesthesia |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age between 6 and 10 years.
- No previous dental experience.
- Definitely positive or positive according to Frank scale.
- Need of maxillary anesthesia for any dental treatment.
Key exclusion criteria (3 listed)
- Previous dental experience
- Systematic or mental disorders.
- Definitely negative or negative according to Frankel scale
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 |
|---|---|---|
| Evaluation the effectiveness of distraction in the reception area in the management of anxious pediatric patients during dental local anesthesiaBuccal and palatal infiltration will be administrated with basic behavior guidance techniques while the dentist wearing conventional attire in the treatment room after meeting the child in the reception area while wearing the friendly attire. | Behavioural | Distraction in the reception area. |
| Evaluation the effectiveness of distraction in the treatment area in the management of anxious pediatric patients during dental local anesthesiaBuccal and palatal infiltration will be administrated with basic behavior guidance techniques while the dentist wearing friendly attire in the treatment room after meeting the child in the reception area while wearing the conventional attire. | Behavioural | Distraction in the treatment area. |
| Evaluation the effectiveness of distraction in both reception and treatment areas in the management of anxious pediatric patients during dental local anesthesiaBuccal and palatal infiltration will be administrated with basic behavior guidance techniques while the dentist wearing friendly attire in the reception area and treatment room. | Behavioural | Distraction in both treatment and reception area. |
| Evaluation of the effectiveness of basic behavior guidance techniques without using any type of distraction aids in the management of anxious pediatric patients during dental local anesthesiaBuccal and palatal infiltration will be administrated with basic behavior guidance techniques while the dentist wearing conventional attire in the reception area and treatment room. | Behavioural | Basic behavior guidance techniques without using any type of distraction aids. |
Primary outcome
Pain levels
Time frame: 5 minutes following the dental local anesthesia.
Pain levels will be measured by using a self-reported simplified Wong-Baker faces pain scale: 0 no Hurt - 1 Hurts little Bit - 2 Hurts little More - 3 Hurts Even More - 4 Hurts Whole Lot - 5 Hurts Worst
Anxiety levels
Time frame: 1 minute during the dental local anesthesia.
This will be evaluated using the Face-Legs-Activity-Cry-Consolability (FLACC) scale (0 low anxiety and pain level - 10 high anxiety and pain level).
Anxiety levels
Time frame: 5 minutes following the meeting with the dentist in the reception area, and 5 minutes after the patient is seated comfortably on the dental chair
This will be evaluated using Children's Fear Scale (0 indicating 'no anxiety' and 4 indicating 'extreme anxiety') and Children Anxiety Questionnaire (self-report) (4 indicating 'no anxiety' and 16 indicating 'extreme anxiety').
Pulse rate
Time frame: (1) five minutes after the patient is seated comfortably in the reception area, (2) five minutes after the patient is seated comfortably on the dental chair, (3) five minutes following the injection of the anesthetic drug
Pulse rate (the number of times your heart beats each minute bpm will be evaluated using Finger Pulse Oximeter.
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 9 Jul 2024.
- Background: PubMed 34326579Kastelic DR, Volpato LE, de Campos Neves AT, Aranha AM, Martins CC. Do Children and Adolescents Prefer Pediatric Attire over White Attire during Dental Appointments? A Meta-analysis of Prevalence Data. Int J Clin Pediatr Dent. 2021 Jan-Feb;14(1):14-29. doi: 10.5005/jp-journals-10005-1861.
- Background: PubMed 26379376Kamavaram Ellore VP, Mohammed M, Taranath M, Ramagoni NK, Kumar V, Gunjalli G. Children and Parent's Attitude and Preferences of Dentist's Attire in Pediatric Dental Practice. Int J Clin Pediatr Dent. 2015 May-Aug;8(2):102-7. doi: 10.5005/jp-journals-10005-1293. Epub 2015 Aug 11.
- Background: PubMed 19284436Festini F, Occhipinti V, Cocco M, Biermann K, Neri S, Giannini C, Galici V, de Martino M, Caprilli S. Use of non-conventional nurses' attire in a paediatric hospital: a quasi-experimental study. J Clin Nurs. 2009 Apr;18(7):1018-26. doi: 10.1111/j.1365-2702.2008.02430.x.
- Background: PubMed 29279683Babaji P, Chauhan PP, Rathod V, Mhatre S, Paul U, Guram G. Evaluation of child preference for dentist attire and usage of camouflage syringe in reduction of anxiety. Eur J Dent. 2017 Oct-Dec;11(4):531-536. doi: 10.4103/ejd.ejd_223_17.
- Background: PubMed 23362335Dionigi A, Sangiorgi D, Flangini R. Clown intervention to reduce preoperative anxiety in children and parents: a randomized controlled trial. J Health Psychol. 2014 Mar;19(3):369-80. doi: 10.1177/1359105312471567. Epub 2013 Jan 29.
- Background: PubMed 26171895Manyande A, Cyna AM, Yip P, Chooi C, Middleton P. Non-pharmacological interventions for assisting the induction of anaesthesia in children. Cochrane Database Syst Rev. 2015 Jul 14;2015(7):CD006447. doi: 10.1002/14651858.CD006447.pub3.
- 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.
Jamila Bchara, DDs principal investigator
Damascus University
Mohannad Laflof, Phd study director
Damascus 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 Evaluation the effectiveness of distraction in the reception area in the management of anxious pediatric patients during dental local anesthesia, Evaluation the effectiveness of distraction in the treatment area in the management of anxious pediatric patients during dental local anesthesia and Evaluation the effectiveness of distraction in both reception and treatment areas in the management of anxious pediatric patients during dental local anesthesia in people with Behavior, Child and Dental Anxiety, run by Damascus University at 1 site in Syria.
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 4 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: finished, as of the sponsor's last update on 9 Jul 2024. 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 Syria. 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?
Pain levels (time frame: 5 minutes following the dental local anesthesia.). 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?
On the ClinicalTrials.gov record for NCT06122883, which also lists 6 linked publications.
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 9 Jul 2024.