Child BehaviorNCT03978390
Improving Children's Cooperation During Dental Injection
A study testing behavioral priming, endowment effect and Positive reinforcement in people with Child Behavior and Acute Pain, run by University of Alberta.
Trial summary
This clinical trial aims to investigate how to increase children cooperation in dental settings using ideas adopted from psychology to make an effective interdisciplinary approach. We want to test how showing images of mainstream superheroes such as Superman, Batman, etc. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Child Behavior, Acute Pain
- What is being tested?
- behavioral priming, endowment effect and Positive reinforcement
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 12 Jun 2019to 12 Jun 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children who need dental treatment and injection
- children between 6 to 12 years old
- children without severe or chronic orofacial pain
- children without chronic systemic disease
- children who had not dental injection in the past six months
- children whose parents are present at the operation room
Who cannot join
- being a non-English speaker
- children whose parents are not willing their child to be videotaped or participate in the study
- history of post-traumatic stress disorders or specific phobia related to the dental settings
- children who supposed to have a dental extraction
- children who stay in the waiting room for more than one hour
About this study
Official title: Behavioral Interventions to Improve Pediatric Patients' Cooperation During the Dental Injection: a Randomized Clinical Trial
This clinical trial aims to investigate how to increase children cooperation in dental settings using ideas adopted from psychology to make an effective interdisciplinary approach. We want to test how showing images of mainstream superheroes such as Superman, Batman, etc. can prepare children, 6-12 years old, to behave desirably during the dental injection. Also, new modification will be applied to providing awards to children by telling them that they can keep the rewards they receive before starting the procedure only if they behave accordingly during the treatment. Moreover, it will be shown that if children's baseline psychological characteristic, age, gender, and family income affect their cooperation in the dental office. The results of this study help to manage children's behavior more efficiently in the clinical settings which is crucial to achieving effective treatment.
Read the detailed description
Purpose:
This clinical trial aims to evaluate the impact of priming effect and endowment effect, concepts derived from psychology, on the behavior of children in mixed dentition period during the dental injection. The moderating role of the psychological traits and demographics of children will be investigated as well. The judgment on the children behaviors will be made based on a well-established instrument which categorizes the behaviors into four levels. The results will contribute to an interdisciplinary approach toward patient management and a treatment plan that let practitioners manage their time more efficiently, and also increase the chance of children's acceptable behaviors and cooperation during a dental visit and attendance in follow-up sessions.
Justification:
Patient management in pediatric dentistry is a matter of great importance as many children may not be as cooperative as adults with their dentist when undergoing dental procedures. Although there were developments in patient management in dentistry, particularly in the pediatric field, an interdisciplinary approach is still lacking to cover all aspects of behavioral management. Specifically, the findings derived from psychology and economics may have the potential to be implemented in the medical field. That being said, the concepts such as behavioral priming and endowment effect and constructs such as personality traits which have led to promising results in cognitive and behavioral management have been scarcely implemented in the medical field and dentistry.
Conditioning or contingency reinforcement is one of the universally accepted techniques in the behavioral management of children in dental clinics. The positive reinforcement is the common approach for reinforcing the desired behaviors in children. Positive reinforcement relies on promising children with positive social feedback (e.g., smile and praise) or non-social token and rewards (e.g., badges and stickers). Although positive reinforcement was reported to be successful, according to the concept of the endowment effect, other conditions of providing awards to children may be even more efficient. The endowment effect, which is a well-reported psychological phenomenon, states that people attribute more value to things that they own and more inclined to retain them than obtaining the same object when they do not possess it. Based on this concept, value is not absolute but perceptual in nature, and perceived ownership would affect perceived value. The endowment effect is supported by the loss aversion stating that losses have a stronger impact than gains. The asymmetry between the impact of positive and negative expectations or experiences on oneself is traced back to evolution. Organisms that had considered dangers as more important than opportunities had a better chance of survival and reproduction. Providing a condition in which children can keep the rewards after treatment only if they behave cooperatively may be more powerful reinforcement than the traditional conditioning. Up to the authors' knowledge, except for limited studies that applied the endowment effect in creating the health policies, it has not been used in the medical field for behavioral management.
Behavioral priming is referred to as the influence of different stimuli such as words, sounds, smells, colors, and pictures on the various cognitive constructs and memory, which in turn impact the behaviors. Overall, primes are classified into two categories based on how an individual percept them, subliminal and conscious. That being said, the influence of both types of primes is mostly outside one's awareness. Several studies in the past decades showed that people can be induced to behave in certain ways such as acting socially or unsocially, walking faster or slower, and being accurate or inaccurate as a result of priming outside of their consciousness. Moreover, some new studies even used the effect of superhero priming on social behaviors and found that exposing individuals to superhero images provokes prosocial activity. Although the influence of the behavioral priming was documented in previous studies, there are still disputes about the underlying mechanisms of the priming effect. The traditional concept supports the enhanced accessibility to memory and psychological constructs that active behaviors related to certain stereotypes. However, neglecting the situational factors and other moderators led to failure in the replication of the effect of primes in some recent studies. Therefore, the new approach toward behavioral priming states that different situational factors play roles in making decisions and behaviors as well. The new approach does not undermine the unconscious effect of the prime on behaviors but emphasizes on considering the situational factors as well as the individuals' characteristics in interpreting the effects.
Besides the inductive effect of environmental forces and primes on behaviors, personality traits can be reliable predictors of decisions and behaviors as well. Personality traits are considered as a reference point and a moderator for different behaviors. This is true, especially in uncertain situations, the presence of weak environmental forces, or extremity of a person in a particular trait. Moreover, personality traits can have an impact on how individuals infer and suffer from pain and consequently, the related behaviors. Some studies reported a meaningful relationship between personality and pain perception. The five-factor theory of personality (FFT): Neuroticism (N), Extraversion (E), Openness (O), Agreeableness (A) and Conscientiousness (C) is a model which takes into account the relationship between personality and health. Furthermore, a recent systematic review found that despite the common belief, the personality traits are not permanent and can be changed through experiences. Therefore, assessing personality traits may not only have predictive value but may be employed to help with the treatment procedure.
Hypothesis:
Up to the authors' knowledge, no study has implemented the concept of endowment effect for behavioral management in the medical or dental field. Besides that, the behavioral priming has not been used in the dental field as well. The hypothesis is that implementing these two concepts can help to improve pediatric patients' cooperation during dental injections.
Objectives:
- To investigate the priming effect of superhero posters as stimuli on the behaviors of pediatric patients during the dental injection
- To compare the two scenarios of giving rewards to pediatric patients, i.e., before starting the treatment (endowment effect) and after finishing the treatment (positive reinforcement), in order to investigate their impact on children behaviors during the dental injection
- To investigate the moderating role of personality traits on the behaviors of pediatric patients during dental injection
- To investigate the moderating effect of age, gender, and family income on the behaviors of pediatric patients during dental injection
Proposed Methodology and Research Plan:
The children in mixed dentition period will participate in this clinical trial. The participants will be selected consecutively of patients refereeing to a specific dental clinic. Before beginning the dental procedures or any interventions, all the parents' of children will be asked to provide a consent form and if they agree and complete the form, then they will be asked to fill out the short form of the hierarchical personality inventory for children (HiPIC-30). The randomized block randomization method will be used to ensure the equal sample size in each group based on the interventions. Half of the children will be seeing images of the superheroes on the dental unit screen for five minutes while waiting for the dental procedure to start. If the patient is a boy, images of three popular male superheroes such as Superman, Batman, and Spiderman will be shown. If the patient is a girl, images of Wonder-woman, Batgirl, and Cat-woman will be shown. The other half of the patients will see no images on the screen. Before starting the treatment procedure, children in each group will again be subdivided into two other groups. One group will be given reward before starting the procedure, but they will be told they only can keep the reward after the treatment if they have a cooperative behavior during the dental procedure (endowment effect). The reward will be put on a tray where the child can see it throughout the dental procedure. The other group will not receive any reward at the beginning, but they will be told that they will be given a reward if they cooperate during the dental procedure to evaluate the effect of positive reinforcement. Children are free to choose their reward, as it has been shown gender, age, and cultural differences may affect the children choice. However, some small toys of superheroes will be included among the awards to test whether seeing the images of superheroes affect the award choice or not. To comply with the ethics, all children will receive the reward after treatment irrespective of their behavior.
The children behavior (outcome measure) during the dental injection will be recorded and scored later using Frankl's scale for general behavior by two examiners to prevent subjectivity of measurement. The children recordings from the time of needle penetration until taking out the needle will be scored. Frankl's scale helps to categorize the behavior into four levels. To reduce the confounding effects, dentists who wear the same coat for every dental visit will perform the dental examinations and procedures. Moreover, the dental office where the examinations take place will be the same for all children.
Sample Size Calculation and Data Analysis:
The sample size will be calculated using GPower v3.1.9 software for the independent t-test. Considering a medium to large effect size=0.6, α level=0.05, statistical power (1-β)=0.85, the sample size of n=102 will be obtained. However, as the outcome measure is non-parametric, an additional 4 samples will be recruited. Therefore, 106 participants will be needed for the non-parametric test. However, considering 10% for drop-outs and missing data, the final sample size will reach 117. The main effects of interventions i.e. priming effect and reward system will be evaluated with the Mann-Whitney test. Moreover, using ordinal logistic regression, the predictive value of the main variables and moderators for children's behavior will be calculated.
Potential Outcomes and Expected Research Contribution:
Patient management in pediatric dentistry is a matter of great importance to achieve a successful and effective treatment. Injecting the children patients is one of the most challenging steps for dentists which determine the cooperation of a child for the rest of the treatment. The techniques proposed in this study are straightforward to apply in dental settings with a minimum of the cost. We hope that the results of this interdisciplinary approach be a step forward for future projects. The results will contribute to an interdisciplinary approach toward patient management and a treatment plan that let practitioners manage their time more efficiently, and also increase the chance of children's acceptable behaviors and cooperation during a dental visit and attendance in follow-up sessions.
- Conditions
- Child Behavior, Acute Pain
- Being tested
- behavioral priming, endowment effect, Positive reinforcement
- Keywords
- Dental Injection, Behavioral Intervention, Behavioral Priming, Endowment Effect, Personality Traits
- Medical subject headings
- Child Behavior, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
behavioral primingBehavioural
Priming the children with images of superheroes in order to behave desirably during the dental injection
endowment effectBehavioural
Giving the rewards to children before starting the dental treatment and telling children they can only keep it if they behave desirably during the dental procedure
Positive reinforcementBehavioural
Giving rewards to the children at the end if they cooperate desirably during the treatment
| Study group | Role | What they receive |
|---|---|---|
| Superhero images, Reward at the beginning, | Experimental | Also, Showing superhero images for 5 minutes before starting the dental procedure. Also, providing the children with reward before begging the dental procedure and telling them that they can only keep it if they cooperate during the treatment procedure. Receives: Behavioral: behavioral priming; Behavioral: endowment effect |
| Superhero images, Reward at the end | Experimental | Universally-accepted positive reinforcement to increase children cooperation in dental settings Receives: Behavioral: behavioral priming; Behavioral: Positive reinforcement |
| No Superhero Images, Reward at the beginning | Experimental | Showing superhero images for 5 minutes before starting the dental procedure Receives: Behavioral: endowment effect |
| No Superhero Images, Reward at the end | Active comparator | Showing no picture before starting the dental procedure Receives: Behavioral: Positive reinforcement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavior of the children during the dental injection
Accessing behavior of children during dental injection (from the time of needle penetration until taking out the needle) using Frankl's scale which categorize behaviors into four levels i.e. 1. definitely negative 2. negative 3. positive 4. definitely positive
Measured: Approximately 20 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2019
- Study start12 Jun 2019
- Primary completion12 Jun 2019
- Study completion12 Jun 2019
Why it stopped: Change in research direction
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child BehaviorStudies 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
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohammad Moharrami, DDS, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03978390
- Sponsor's protocol ID
- Pro00091797
- Status last verified
- Jul 2020
- First submitted
- 5 Jun 2019
- Last updated
- 27 Jul 2020
- 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 27 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Interventions to Improve Pediatric Patients' Cooperation During the Dental Injection: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03978390
- Acronym / sponsor ID
- Pro00091797
- Conditions
- Child Behavior, Acute Pain
- Keywords
- Dental Injection, Behavioral Intervention, Behavioral Priming, Endowment Effect, Personality Traits
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Change in research direction
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 12 Jun 2019 (actual)
- Primary completion
- 12 Jun 2019 (actual)
- Study completion
- 12 Jun 2019 (actual)
- First posted
- 7 Jun 2019 (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.
This clinical trial aims to investigate how to increase children cooperation in dental settings using ideas adopted from psychology to make an effective interdisciplinary approach. We want to test how showing images of mainstream superheroes such as Superman, Batman, etc. can prepare children, 6-12 years old, to behave desirably during the dental injection. Also, new modification will be applied to providing awards to children by telling them that they can keep the rewards they receive before starting the procedure only if they behave accordingly during the treatment. Moreover, it will be shown that if children's baseline psychological characteristic, age, gender, and family income affect their cooperation in the dental office. The results of this study help to manage children's behavior more efficiently in the clinical settings which is crucial to achieving effective treatment.
Detailed description
Purpose:
This clinical trial aims to evaluate the impact of priming effect and endowment effect, concepts derived from psychology, on the behavior of children in mixed dentition period during the dental injection. The moderating role of the psychological traits and demographics of children will be investigated as well. The judgment on the children behaviors will be made based on a well-established instrument which categorizes the behaviors into four levels. The results will contribute to an interdisciplinary approach toward patient management and a treatment plan that let practitioners manage their time more efficiently, and also increase the chance of children's acceptable behaviors and cooperation during a dental visit and attendance in follow-up sessions.
Justification:
Patient management in pediatric dentistry is a matter of great importance as many children may not be as cooperative as adults with their dentist when undergoing dental procedures. Although there were developments in patient management in dentistry, particularly in the pediatric field, an interdisciplinary approach is still lacking to cover all aspects of behavioral management. Specifically, the findings derived from psychology and economics may have the potential to be implemented in the medical field. That being said, the concepts such as behavioral priming and endowment effect and constructs such as personality traits which have led to promising results in cognitive and behavioral management have been scarcely implemented in the medical field and dentistry.
Conditioning or contingency reinforcement is one of the universally accepted techniques in the behavioral management of children in dental clinics. The positive reinforcement is the common approach for reinforcing the desired behaviors in children. Positive reinforcement relies on promising children with positive social feedback (e.g., smile and praise) or non-social token and rewards (e.g., badges and stickers). Although positive reinforcement was reported to be successful, according to the concept of the endowment effect, other conditions of providing awards to children may be even more efficient. The endowment effect, which is a well-reported psychological phenomenon, states that people attribute more value to things that they own and more inclined to retain them than obtaining the same object when they do not possess it. Based on this concept, value is not absolute but perceptual in nature, and perceived ownership would affect perceived value. The endowment effect is supported by the loss aversion stating that losses have a stronger impact than gains. The asymmetry between the impact of positive and negative expectations or experiences on oneself is traced back to evolution. Organisms that had considered dangers as more important than opportunities had a better chance of survival and reproduction. Providing a condition in which children can keep the rewards after treatment only if they behave cooperatively may be more powerful reinforcement than the traditional conditioning. Up to the authors' knowledge, except for limited studies that applied the endowment effect in creating the health policies, it has not been used in the medical field for behavioral management.
Behavioral priming is referred to as the influence of different stimuli such as words, sounds, smells, colors, and pictures on the various cognitive constructs and memory, which in turn impact the behaviors. Overall, primes are classified into two categories based on how an individual percept them, subliminal and conscious. That being said, the influence of both types of primes is mostly outside one's awareness. Several studies in the past decades showed that people can be induced to behave in certain ways such as acting socially or unsocially, walking faster or slower, and being accurate or inaccurate as a result of priming outside of their consciousness. Moreover, some new studies even used the effect of superhero priming on social behaviors and found that exposing individuals to superhero images provokes prosocial activity. Although the influence of the behavioral priming was documented in previous studies, there are still disputes about the underlying mechanisms of the priming effect. The traditional concept supports the enhanced accessibility to memory and psychological constructs that active behaviors related to certain stereotypes. However, neglecting the situational factors and other moderators led to failure in the replication of the effect of primes in some recent studies. Therefore, the new approach toward behavioral priming states that different situational factors play roles in making decisions and behaviors as well. The new approach does not undermine the unconscious effect of the prime on behaviors but emphasizes on considering the situational factors as well as the individuals' characteristics in interpreting the effects.
Besides the inductive effect of environmental forces and primes on behaviors, personality traits can be reliable predictors of decisions and behaviors as well. Personality traits are considered as a reference point and a moderator for different behaviors. This is true, especially in uncertain situations, the presence of weak environmental forces, or extremity of a person in a particular trait. Moreover, personality traits can have an impact on how individuals infer and suffer from pain and consequently, the related behaviors. Some studies reported a meaningful relationship between personality and pain perception. The five-factor theory of personality (FFT): Neuroticism (N), Extraversion (E), Openness (O), Agreeableness (A) and Conscientiousness (C) is a model which takes into account the relationship between personality and health. Furthermore, a recent systematic review found that despite the common belief, the personality traits are not permanent and can be changed through experiences. Therefore, assessing personality traits may not only have predictive value but may be employed to help with the treatment procedure.
Hypothesis:
Up to the authors' knowledge, no study has implemented the concept of endowment effect for behavioral management in the medical or dental field. Besides that, the behavioral priming has not been used in the dental field as well. The hypothesis is that implementing these two concepts can help to improve pediatric patients' cooperation during dental injections.
Objectives:
- To investigate the priming effect of superhero posters as stimuli on the behaviors of pediatric patients during the dental injection
- To compare the two scenarios of giving rewards to pediatric patients, i.e., before starting the treatment (endowment effect) and after finishing the treatment (positive reinforcement), in order to investigate their impact on children behaviors during the dental injection
- To investigate the moderating role of personality traits on the behaviors of pediatric patients during dental injection
- To investigate the moderating effect of age, gender, and family income on the behaviors of pediatric patients during dental injection
Proposed Methodology and Research Plan:
The children in mixed dentition period will participate in this clinical trial. The participants will be selected consecutively of patients refereeing to a specific dental clinic. Before beginning the dental procedures or any interventions, all the parents' of children will be asked to provide a consent form and if they agree and complete the form, then they will be asked to fill out the short form of the hierarchical personality inventory for children (HiPIC-30). The randomized block randomization method will be used to ensure the equal sample size in each group based on the interventions. Half of the children will be seeing images of the superheroes on the dental unit screen for five minutes while waiting for the dental procedure to start. If the patient is a boy, images of three popular male superheroes such as Superman, Batman, and Spiderman will be shown. If the patient is a girl, images of Wonder-woman, Batgirl, and Cat-woman will be shown. The other half of the patients will see no images on the screen. Before starting the treatment procedure, children in each group will again be subdivided into two other groups. One group will be given reward before starting the procedure, but they will be told they only can keep the reward after the treatment if they have a cooperative behavior during the dental procedure (endowment effect). The reward will be put on a tray where the child can see it throughout the dental procedure. The other group will not receive any reward at the beginning, but they will be told that they will be given a reward if they cooperate during the dental procedure to evaluate the effect of positive reinforcement. Children are free to choose their reward, as it has been shown gender, age, and cultural differences may affect the children choice. However, some small toys of superheroes will be included among the awards to test whether seeing the images of superheroes affect the award choice or not. To comply with the ethics, all children will receive the reward after treatment irrespective of their behavior.
The children behavior (outcome measure) during the dental injection will be recorded and scored later using Frankl's scale for general behavior by two examiners to prevent subjectivity of measurement. The children recordings from the time of needle penetration until taking out the needle will be scored. Frankl's scale helps to categorize the behavior into four levels. To reduce the confounding effects, dentists who wear the same coat for every dental visit will perform the dental examinations and procedures. Moreover, the dental office where the examinations take place will be the same for all children.
Sample Size Calculation and Data Analysis:
The sample size will be calculated using GPower v3.1.9 software for the independent t-test. Considering a medium to large effect size=0.6, α level=0.05, statistical power (1-β)=0.85, the sample size of n=102 will be obtained. However, as the outcome measure is non-parametric, an additional 4 samples will be recruited. Therefore, 106 participants will be needed for the non-parametric test. However, considering 10% for drop-outs and missing data, the final sample size will reach 117. The main effects of interventions i.e. priming effect and reward system will be evaluated with the Mann-Whitney test. Moreover, using ordinal logistic regression, the predictive value of the main variables and moderators for children's behavior will be calculated.
Potential Outcomes and Expected Research Contribution:
Patient management in pediatric dentistry is a matter of great importance to achieve a successful and effective treatment. Injecting the children patients is one of the most challenging steps for dentists which determine the cooperation of a child for the rest of the treatment. The techniques proposed in this study are straightforward to apply in dental settings with a minimum of the cost. We hope that the results of this interdisciplinary approach be a step forward for future projects. The results will contribute to an interdisciplinary approach toward patient management and a treatment plan that let practitioners manage their time more efficiently, and also increase the chance of children's acceptable behaviors and cooperation during a dental visit and attendance in follow-up sessions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Superhero images, Reward at the beginning, | Experimental | Behavioral: behavioral priming, Behavioral: endowment effectAlso, Showing superhero images for 5 minutes before starting the dental procedure. Also, providing the children with reward before begging the dental procedure and telling them that they can only keep it if they cooperate during the treatment procedure. |
| Superhero images, Reward at the end | Experimental | Behavioral: behavioral priming, Behavioral: Positive reinforcementUniversally-accepted positive reinforcement to increase children cooperation in dental settings |
| No Superhero Images, Reward at the beginning | Experimental | Behavioral: endowment effectShowing superhero images for 5 minutes before starting the dental procedure |
| No Superhero Images, Reward at the end | Active comparator | Behavioral: Positive reinforcementShowing no picture before starting the dental procedure |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- children who need dental treatment and injection
- children between 6 to 12 years old
- children without severe or chronic orofacial pain
- children without chronic systemic disease
- children who had not dental injection in the past six months
Key exclusion criteria (5 listed)
- being a non-English speaker
- children whose parents are not willing their child to be videotaped or participate in the study
- history of post-traumatic stress disorders or specific phobia related to the dental settings
- children who supposed to have a dental extraction
- children who stay in the waiting room for more than one hour
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 |
|---|---|---|
| behavioral primingPriming the children with images of superheroes in order to behave desirably during the dental injection | Behavioural | Superhero images, Reward at the beginning,, Superhero images, Reward at the end |
| endowment effectGiving the rewards to children before starting the dental treatment and telling children they can only keep it if they behave desirably during the dental procedure | Behavioural | No Superhero Images, Reward at the beginning, Superhero images, Reward at the beginning, |
| Positive reinforcementGiving rewards to the children at the end if they cooperate desirably during the treatment | Behavioural | No Superhero Images, Reward at the end, Superhero images, Reward at the end |
Primary outcome
Behavior of the children during the dental injection
Time frame: Approximately 20 seconds
Accessing behavior of children during dental injection (from the time of needle penetration until taking out the needle) using Frankl's scale which categorize behaviors into four levels i.e. 1. definitely negative 2. negative 3. positive 4. definitely positive
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 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.
Mohammad Moharrami, DDS principal investigator
University of Alberta
Questions about this trial
What is this clinical trial studying?
A study testing behavioral priming, endowment effect and Positive reinforcement in people with Child Behavior and Acute Pain, run by University of Alberta.
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 5 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: withdrawn, as of the sponsor's last update on 27 Jul 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 was withdrawn before enrolling participants, so there are no results.
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?
Behavior of the children during the dental injection (time frame: Approximately 20 seconds). 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 27 Jul 2020.