Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT03978390 |
| Other study ID # |
Pro00091797 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 12, 2019 |
| Est. completion date |
June 12, 2019 |
Study information
| Verified date |
July 2020 |
| Source |
University of Alberta |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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.
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.
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:
1. To investigate the priming effect of superhero posters as stimuli on the behaviors of
pediatric patients during the dental injection
2. 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
3. To investigate the moderating role of personality traits on the behaviors of pediatric
patients during dental injection
4. 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.
