Cooperative BehaviourNCT01908127
Efficacy of Film Modelling in Paediatric Dentistry
A study testing tell- show- do, film modelling and injection of local anesthesia solution in people with Cooperative Behaviour and Dental Anxiety, run by Zahedan University of Medical Sciences at 1 site in Iran.
Trial summary
The aim of this study is to evaluate the effect of Filmed modelling in comparison with commonly used Tell-Show-Do technique on the anxious and cooperative behaviour of 4-6 years old children during dental practice. Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Cooperative Behaviour, Dental Anxiety
- What is being tested?
- tell- show- do, film modelling and injection of local anesthesia solution
- Type of treatment
- Injection or infusion, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIran
- Study dates
- Sep 2010to Apr 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- children aged 4-6 years
- caries lesion in one of the primary mandibular molars needs to pulpotomy and restoration treatment.
Who cannot join
- children with systemic diseases and developmental disorders
- previous experience of hospitalization
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Filmed Modelling on the Anxious and Cooperative Behaviour of 4-6 Years Old Children During Dental Treatment
The aim of this study is to evaluate the effect of Filmed modelling in comparison with commonly used Tell-Show-Do technique on the anxious and cooperative behaviour of 4-6 years old children during dental practice.
Read the detailed description
This randomized clinical trial study was approved by ethics committee of Zahedan University of Medical Sciences and conducted in pediatric clinic of Zahedan dental school in 2010.
Among the patients referred to the clinic, forty six children aged 4-6 years (±2 months) were selected according to the inclusion criteria. They had caries lesion in one of the primary mandibular molars needed the pulpotomy and restoration treatment. It was confirmed that they have no previous experience of hospitalization and dental visit. The children with systemic diseases and developmental disorders were excluded from the study. The examination was completed and the necessary radiographies were prescribed.
Each child's parent was asked to complete the informed consent and a questionnaire gathering demographic characteristics of the child and family. Then, the child was enrolled in one of the study groups based on simple random sampling model as follow:
Group I (Tell- Show- Do Group): Children came in the operation room. Tell-Show-Do, prophylaxis with paste and rubber cap and fluoride therapy was performed by the dentist for each participant to increase their familiarity with dental procedures. The duration of the appointment was about 20 minutes and constant for all children. At the end of the first visit, the child was rewarded and the date of the second treatment visit was set for one week later.
In the second session, the child was entered the operating room alone. A video-camera located on the top of the dental unit light pole under a covering cloth was focused on the child's head and hands and started to record child's behavior.
The required injection including a mandibular alveolar nerve block technique was performed by the dentist. The heart beat rate of each child was recorded manually before and following the injection by the dentist. Then, the occlusal cavity was prepared for pulpotomy and restoration of the teeth. The treatment protocol was the same for all the participants.
In all children, parameters such as the attending dentist, his assistant, the working environment, time and duration (30 minutes for each child) of work, and the type of dialogues were all the same. Care was taken to make sure that the children were not tired, hungry, or did not have a common cold.
Group II (Filmed modelling Group): the children were directed to a quiet and comfort room to watch a film presented by a dental assistant. The film showed that the same procedure consisted of Tell-Show-Do, prophylaxis with paste and rubber cap and fluoride therapy was performed on a 5-years-old child model with a time of 20 minutes which was cooperative and reinforced by a reward at the end of the procedure. The produced film had been approved by 3 pediatric dentists.
The second treatment session was set for one week later. Dental procedures, measurement of the heart rate and recording of the behaviors were all performed as in Group I.
The recorded video tapes of all children were independently evaluated by 2 pediatric dentists who were blind to the grouping of the children. Children's anxiety reactions and cooperative behaviors were scored based on Venham Scale and Frankle Index, respectively .The viewers were asked to rate the child's responses in two stages: At the injection of local anesthesia and at the beginning of the tooth preparation.
Statistical analysis Mean of heart rate measurements and behavioral ratings were used for statistical analyses. Data analysis was performed applying t-test method in package of statistical software (SPSS- 15). All statistical references were made at 0.05.
- Conditions
- Cooperative Behaviour, Dental Anxiety
- Being tested
- tell- show- do, film modelling, injection of local anesthesia solution, occlusal cavity preparation
- Keywords
- film modelling, dental anxiety, cooperative behaviour, children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tell- show- doBehavioural
Children came in the operation room. Tell-Show-Do, prophylaxis with paste and rubber cap and fluoride therapy was performed by the dentist for each participant to increase their familiarity with dental procedures. The duration of the appointment was about 20 minutes and constant for all children.
film modellingBehavioural
the children were directed to a quiet and comfort room to watch a film presented by a dental assistant. The film showed that the same procedure consisted of Tell-Show-Do, prophylaxis with paste and rubber cap and fluoride therapy was performed on a 5-years-old child model with a time of 20 minutes. The child in the film was cooperative and was reinforced by a reward at the end of the procedure.
injection of local anesthesia solutionDrug
A topical anesthesia and injection of local anesthesia solution using mandibular alveolar nerve block technique was performed by the dentist
occlusal cavity preparationProcedure or surgery
the occlusal cavity was prepared for pulpotomy and restoration of the teeth
| Study group | Role | What they receive |
|---|---|---|
| tell- show- do procedure | Active comparator | Group I (Tell- Show- Do Group): Tell-Show-Do, prophylaxis with paste and rubber cap and fluoride therapy was performed by the dentist for each participant in the operation room.
In the second session,injection of loal anesthesia solution including a mandibular alveolar nerve block technique and the occlusal cavity preparation was performed. Receives: Behavioral: tell- show- do; Drug: injection of local anesthesia solution; Procedure: occlusal cavity preparation |
| film modelling | Experimental | Group II (Filmed modelling Group): the children were directed to a quiet and comfort room to watch a film presented by a dental assistant. The film showed that the same procedure consisted of Tell-Show-Do, prophylaxis with paste and rubber cap and fluoride therapy was performed on a 5-years-old child model with a time of 20 minutes. The child in the film was cooperative and was reinforced by a reward at the end of the procedure.
In the second session, injection of loal anesthesia solution including a mandibular alveolar nerve block technique and the occlusal cavity preparation was performed. Receives: Behavioral: film modelling; Drug: injection of local anesthesia solution; Procedure: occlusal cavity preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behaviors of Children
A video-camera was focused started to record child's behavior. The recorded video tapes were independently evaluated by 2 paediatric dentists who were blind to the grouping of the children. Children's anxiety reactions and cooperative behaviours were scored based on venham scale and Frankle Index ,respectively. quantification was performed at the injection of local anaesthesia and at the beginning of the tooth preparation. An average of both two time points scoring was used.
Table 1: Venham 6-point Index 0 = Relaxed: 1 = Uneasy: 2 = Tense: 3 = Reluctant: 4 = Interference: 5 = Out of contact
Table 2: Frankle 4-point Index
1:Definitely Negative ( uncooperative,Refusal of treatment ) , 2:Negative ( some evidence of negative attitude but not pronounced) , 3:Positive ( Acceptance of treatment, at times cautious) , 4:Definitely Positive( Good rapport with the dentist)
Measured: participants followed for the duration of examination and treatment appointment, an expected average of 3 weeks
Secondary outcomes (1)
Index of Heart Rate
The heart rate of children was measured before the injection of local anesthesia solution to save a baseline data and it was also measured after the injection to assess the effect of this dental stress.
Measured: before and after the injection of local anesthesia solution
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2013 (estimated)
- Study startSep 2010
- Primary completionFeb 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cooperative BehaviourStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zahedan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mehrsa paryab, Zahedan University of Medical Sciences
- Investigators
- mehrsa paryab, Dr, Principal investigator, dental school, tehran university of medical sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01908127
- Sponsor's protocol ID
- 1382
- Status last verified
- Dec 2013
- First submitted
- 17 Jul 2013
- Last updated
- 20 Jan 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Filmed Modelling on the Anxious and Cooperative Behaviour of 4-6 Years Old Children During Dental Treatment
- ClinicalTrials.gov ID
- NCT01908127
- Acronym / sponsor ID
- 1382
- Conditions
- Cooperative Behaviour, Dental Anxiety
- Keywords
- film modelling, dental anxiety, cooperative behaviour, children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Zahedan University of Medical SciencesUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 25 Jul 2013 (estimated)
- Results
- Posted 20 Jan 2014
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 Filmed modelling in comparison with commonly used Tell-Show-Do technique on the anxious and cooperative behaviour of 4-6 years old children during dental practice.
Detailed description
This randomized clinical trial study was approved by ethics committee of Zahedan University of Medical Sciences and conducted in pediatric clinic of Zahedan dental school in 2010.
Among the patients referred to the clinic, forty six children aged 4-6 years (±2 months) were selected according to the inclusion criteria. They had caries lesion in one of the primary mandibular molars needed the pulpotomy and restoration treatment. It was confirmed that they have no previous experience of hospitalization and dental visit. The children with systemic diseases and developmental disorders were excluded from the study. The examination was completed and the necessary radiographies were prescribed.
Each child's parent was asked to complete the informed consent and a questionnaire gathering demographic characteristics of the child and family. Then, the child was enrolled in one of the study groups based on simple random sampling model as follow:
Group I (Tell- Show- Do Group): Children came in the operation room. Tell-Show-Do, prophylaxis with paste and rubber cap and fluoride therapy was performed by the dentist for each participant to increase their familiarity with dental procedures. The duration of the appointment was about 20 minutes and constant for all children. At the end of the first visit, the child was rewarded and the date of the second treatment visit was set for one week later.
In the second session, the child was entered the operating room alone. A video-camera located on the top of the dental unit light pole under a covering cloth was focused on the child's head and hands and started to record child's behavior.
The required injection including a mandibular alveolar nerve block technique was performed by the dentist. The heart beat rate of each child was recorded manually before and following the injection by the dentist. Then, the occlusal cavity was prepared for pulpotomy and restoration of the teeth. The treatment protocol was the same for all the participants.
In all children, parameters such as the attending dentist, his assistant, the working environment, time and duration (30 minutes for each child) of work, and the type of dialogues were all the same. Care was taken to make sure that the children were not tired, hungry, or did not have a common cold.
Group II (Filmed modelling Group): the children were directed to a quiet and comfort room to watch a film presented by a dental assistant. The film showed that the same procedure consisted of Tell-Show-Do, prophylaxis with paste and rubber cap and fluoride therapy was performed on a 5-years-old child model with a time of 20 minutes which was cooperative and reinforced by a reward at the end of the procedure. The produced film had been approved by 3 pediatric dentists.
The second treatment session was set for one week later. Dental procedures, measurement of the heart rate and recording of the behaviors were all performed as in Group I.
The recorded video tapes of all children were independently evaluated by 2 pediatric dentists who were blind to the grouping of the children. Children's anxiety reactions and cooperative behaviors were scored based on Venham Scale and Frankle Index, respectively .The viewers were asked to rate the child's responses in two stages: At the injection of local anesthesia and at the beginning of the tooth preparation.
Statistical analysis Mean of heart rate measurements and behavioral ratings were used for statistical analyses. Data analysis was performed applying t-test method in package of statistical software (SPSS- 15). All statistical references were made at 0.05.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tell- show- do procedure | Active comparator | Behavioral: tell- show- do, Drug: injection of local anesthesia solution, Procedure: occlusal cavity preparationGroup I (Tell- Show- Do Group): Tell-Show-Do, prophylaxis with paste and rubber cap and fluoride therapy was performed by the dentist for each participant in the operation room. In the second session,injection of loal anesthesia solution including a mandibular alveolar nerve block technique and the occlusal cavity preparation was performed. |
| film modelling | Experimental | Behavioral: film modelling, Drug: injection of local anesthesia solution, Procedure: occlusal cavity preparationGroup II (Filmed modelling Group): the children were directed to a quiet and comfort room to watch a film presented by a dental assistant. The film showed that the same procedure consisted of Tell-Show-Do, prophylaxis with paste and rubber cap and fluoride therapy was performed on a 5-years-old child model with a time of 20 minutes. The child in the film was cooperative and was reinforced by a reward at the end of the procedure. In the second session, injection of loal anesthesia solution including a mandibular alveolar nerve block technique and the occlusal cavity preparation was performed. |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- children aged 4-6 years
- caries lesion in one of the primary mandibular molars needs to pulpotomy and restoration treatment.
Key exclusion criteria (2 listed)
- children with systemic diseases and developmental disorders
- previous experience of hospitalization
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 |
|---|---|---|
| tell- show- doChildren came in the operation room. Tell-Show-Do, prophylaxis with paste and rubber cap and fluoride therapy was performed by the dentist for each participant to increase their familiarity with dental procedures. The duration of the appointment was about 20 minutes and constant for all children. | Behavioural | tell- show- do procedure |
| film modellingthe children were directed to a quiet and comfort room to watch a film presented by a dental assistant. The film showed that the same procedure consisted of Tell-Show-Do, prophylaxis with paste and rubber cap and fluoride therapy was performed on a 5-years-old child model with a time of 20 minutes. The child in the film was cooperative and was reinforced by a reward at the end of the procedure. | Behavioural | film modelling |
| injection of local anesthesia solutionA topical anesthesia and injection of local anesthesia solution using mandibular alveolar nerve block technique was performed by the dentist | Drug | film modelling, tell- show- do procedure |
| occlusal cavity preparationthe occlusal cavity was prepared for pulpotomy and restoration of the teeth | Procedure or surgery | film modelling, tell- show- do procedure |
Primary outcome
Behaviors of Children
Time frame: participants followed for the duration of examination and treatment appointment, an expected average of 3 weeks
A video-camera was focused started to record child's behavior. The recorded video tapes were independently evaluated by 2 paediatric dentists who were blind to the grouping of the children. Children's anxiety reactions and cooperative behaviours were scored based on venham scale and Frankle Index ,respectively. quantification was performed at the injection of local anaesthesia and at the beginning of the tooth preparation. An average of both two time points scoring was used. Table 1: Venham 6-point Index 0 = Relaxed: 1 = Uneasy: 2 = Tense: 3 = Reluctant: 4 = Interference: 5 = Out of contact Table 2: Frankle 4-point Index 1:Definitely Negative ( uncooperative,Refusal of treatment ) , 2:Negative ( some evidence of negative attitude but not pronounced) , 3:Positive ( Acceptance of treatment, at times cautious) , 4:Definitely Positive( Good rapport with the dentist)
1 secondary outcome
Index of Heart Rate
Time frame: before and after the injection of local anesthesia solution
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
mehrsa paryab, Dr principal investigator
dental school, tehran university of medical sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tell- show- do, film modelling and injection of local anesthesia solution in people with Cooperative Behaviour and Dental Anxiety, run by Zahedan University of Medical Sciences at 1 site in Iran.
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 2 inclusion and 2 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 20 Jan 2014. 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 Iran. 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?
Yes. Results are posted in the registry (first posted 20 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Behaviors of Children (time frame: participants followed for the duration of examination and treatment appointment, an expected average of 3 weeks). 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 20 Jan 2014.