MotivationNCT04258748
Effect of Motivational Interviewing and Game Based Education on Oral Hygiene Behavior of Preschool Children
A study testing Motivational Interviewing (MI), Gaming and MI and Conventional dental health education in people with Motivation, run by Nourhan M.Aly at 1 site in Egypt.
Trial summary
The purpose of this study was to evaluate the effectiveness of motivational interviewing as well as games in changing oral health behaviors among preschool children. Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Motivation
- What is being tested?
- Motivational Interviewing (MI), Gaming and MI and Conventional dental health education
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteEgypt
- Study dates
- 29 May 2017to 5 Jan 2020
- 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 4 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children having unfavorable oral health behavior (reporting a maximum tooth brushing frequency of 1-2 times/ week).
- The child's mother agreed to join the study so that parent/child can be recruited as pairs/dyads.
- Children enrolled in one of the nurseries selected
Who cannot join
- Children having a history of serious medical condition or special care needs
- Using any type of removable appliances such as space maintainer or tongue guard.
- Children whose mothers refused to give consent to participate in the study.
- Illiterate mothers who were not able to understand the oral health materials and instructions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Motivational Interviewing and Game Based Education on Oral Hygiene Behavior of Preschool Children in Beheira Governorate, Egypt
The purpose of this study was to evaluate the effectiveness of motivational interviewing as well as games in changing oral health behaviors among preschool children.
Read the detailed description
The participating children, in this randomized controlled clinical trial, were recruited from the governmental preschools available within Edko administration of Beheira governorate, Egypt. A cluster random sampling strategy was used so that the contributors, after fulfilling eligibility criteria, mother/child dyads (pairs) in each nursery were subsequently assigned to the first test group (motivational interviewing MI), the second test group (motivational interviewing MI+ gaming) or the control group (conventional dental health education CE). The children were randomly assigned to the three study groups in the allocation ratio 1:1:1 using random allocation software in blocks of five. The schools' randomization sequence were written on identical sheets of paper and folded inside opaque envelopes that were sealed to be open at the time of intervention implementation.
The three interventions were the conventional dental health education (CE) which were delivered through a 15-minute oral health session given to mothers of preschoolers in the control group whereas in the test groups Motivational Interviewing (MI) for mothers and Games for children were carried out via specific phases.
- Conditions
- Motivation
- Being tested
- Motivational Interviewing (MI), Gaming and MI, Conventional dental health education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational Interviewing (MI)Behavioural
In each of the four MI counseling sessions that were delivered, the researcher approached mothers in small groups of 5 via three phases, in 15-30 minutes, to establish rapport/ alliance in the first phase, to identify health needs in the second phase and finally to reinforce dental needs in the third phase.
Gaming and MIBehavioural
In each of the four MI counseling sessions, the researcher approached mothers via three phases, in 15-30 minutes, to establish rapport/ alliance, to identify and finally reinforce dental needs in the same pattern as MI group. In addition, the children were engaged in 'Happy Teeth, Healthy Kids' which is an android tablet game that was included in the MI session scheduled for the mothers. Children were told to follow correct steps of brushing in order to obtain happy bright teeth. This helped the children realize that brushing teeth will give them a bright smile.
Conventional dental health educationBehavioural
It was delivered through a 15-minutes oral health session given to mothers of preschoolers. Mothers were given brief information about causes of dental caries and role of plaque, toothbrush size, diet / frequency of sweet snacks, brushing technique, toothpaste and fluoride use as well as regular dental visits. Participants were then shown a short educational video about prevention of dental caries among children coupled with oral hygiene instructions. At the end of the session, participants were given a leaflet reinforcing the information to take home.
| Study group | Role | What they receive |
|---|---|---|
| Motivational Interviewing (MI) | Experimental | Not described Receives: Behavioral: Motivational Interviewing (MI) |
| Gaming and MI | Experimental | Not described Receives: Behavioral: Gaming and MI |
| Conventional dental health education | Active comparator | Not described Receives: Behavioral: Conventional dental health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of dental plaque accumulation
It was assesed using modified OHI-S.The presence of plaque was verified on the buccal surface of 6 index teeth: the upper right second deciduous molar (tooth 55), the upper right central deciduous incisor (tooth 51), the upper left second deciduous molar (tooth 65), the lower right second deciduous molar (tooth 85), the lower left central deciduous incisor (tooth 71), and the lower left second deciduous molar (tooth 75). According to the OHI-S, dental plaque is defined as a soft organic material loosely adhering to the tooth surface. The tooth surface covered by plaque was estimated by visual examination according to the following criteria: 0 =no plaque present; 1 = plaque covering no more than 1/3 of the surface in question; 2 = plaque covering more than 1/3, but no more than 2/3 of the surface; 3= plaque covering more than 2/3 of the surface; 9 = tooth excluded, no information.
Measured: baseline
Rate of dental plaque accumulation
It was assesed using modified OHI-S.The presence of plaque was verified on the buccal surface of 6 index teeth: the upper right second deciduous molar (tooth 55), the upper right central deciduous incisor (tooth 51), the upper left second deciduous molar (tooth 65), the lower right second deciduous molar (tooth 85), the lower left central deciduous incisor (tooth 71), and the lower left second deciduous molar (tooth 75). According to the OHI-S, dental plaque is defined as a soft organic material loosely adhering to the tooth surface. The tooth surface covered by plaque was estimated by visual examination according to the following criteria: 0 =no plaque present; 1 = plaque covering no more than 1/3 of the surface in question; 2 = plaque covering more than 1/3, but no more than 2/3 of the surface; 3= plaque covering more than 2/3 of the surface; 9 = tooth excluded, no information.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start29 May 2017
- Primary completion30 Aug 2019
- Study completion5 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MotivationStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nourhan M.Aly
- Sponsor type
- University, hospital or other
- Collaborators
- Alexandria University
- Responsible party
- Sponsor-investigator, Nourhan M.Aly, University of Alexandria
- Investigators
- Amani Nomair, BDS, Principal investigator, Faculty of Dentistry, Alexandria University, EgyptMaha Hamza, PhD, Study director, Faculty of Dentistry, Alexandria University, EgyptWafaa Essameldin, PhD, Study director, Faculty of Dentistry, Alexandria University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04258748
- Sponsor's protocol ID
- MI and game based education
- Status last verified
- Aug 2020
- First submitted
- 4 Feb 2020
- Last updated
- 20 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Motivational Interviewing and Game Based Education on Oral Hygiene Behavior of Preschool Children in Beheira Governorate, Egypt
- ClinicalTrials.gov ID
- NCT04258748
- Acronym / sponsor ID
- MI and game based education
- Conditions
- Motivation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Nourhan M.AlyUniversity, hospital or other
- Collaborators
- Alexandria University
- Study start
- 29 May 2017 (actual)
- Primary completion
- 30 Aug 2019 (actual)
- Study completion
- 5 Jan 2020 (actual)
- First posted
- 6 Feb 2020 (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 purpose of this study was to evaluate the effectiveness of motivational interviewing as well as games in changing oral health behaviors among preschool children.
Detailed description
The participating children, in this randomized controlled clinical trial, were recruited from the governmental preschools available within Edko administration of Beheira governorate, Egypt. A cluster random sampling strategy was used so that the contributors, after fulfilling eligibility criteria, mother/child dyads (pairs) in each nursery were subsequently assigned to the first test group (motivational interviewing MI), the second test group (motivational interviewing MI+ gaming) or the control group (conventional dental health education CE). The children were randomly assigned to the three study groups in the allocation ratio 1:1:1 using random allocation software in blocks of five. The schools' randomization sequence were written on identical sheets of paper and folded inside opaque envelopes that were sealed to be open at the time of intervention implementation.
The three interventions were the conventional dental health education (CE) which were delivered through a 15-minute oral health session given to mothers of preschoolers in the control group whereas in the test groups Motivational Interviewing (MI) for mothers and Games for children were carried out via specific phases.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Motivational Interviewing (MI) | Experimental | Behavioral: Motivational Interviewing (MI) |
| Gaming and MI | Experimental | Behavioral: Gaming and MI |
| Conventional dental health education | Active comparator | Behavioral: Conventional dental health education |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children having unfavorable oral health behavior (reporting a maximum tooth brushing frequency of 1-2 times/ week).
- The child's mother agreed to join the study so that parent/child can be recruited as pairs/dyads.
- Children enrolled in one of the nurseries selected
Key exclusion criteria (4 listed)
- Children having a history of serious medical condition or special care needs
- Using any type of removable appliances such as space maintainer or tongue guard.
- Children whose mothers refused to give consent to participate in the study.
- Illiterate mothers who were not able to understand the oral health materials and instructions.
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 |
|---|---|---|
| Motivational Interviewing (MI)In each of the four MI counseling sessions that were delivered, the researcher approached mothers in small groups of 5 via three phases, in 15-30 minutes, to establish rapport/ alliance in the first phase, to identify health needs in the second phase and finally to reinforce dental needs in the third phase. | Behavioural | Motivational Interviewing (MI) |
| Gaming and MIIn each of the four MI counseling sessions, the researcher approached mothers via three phases, in 15-30 minutes, to establish rapport/ alliance, to identify and finally reinforce dental needs in the same pattern as MI group. In addition, the children were engaged in 'Happy Teeth, Healthy Kids' which is an android tablet game that was included in the MI session scheduled for the mothers. Children were told to follow correct steps of brushing in order to obtain happy bright teeth. This helped the children realize that brushing teeth will give them a bright smile. | Behavioural | Gaming and MI |
| Conventional dental health educationIt was delivered through a 15-minutes oral health session given to mothers of preschoolers. Mothers were given brief information about causes of dental caries and role of plaque, toothbrush size, diet / frequency of sweet snacks, brushing technique, toothpaste and fluoride use as well as regular dental visits. Participants were then shown a short educational video about prevention of dental caries among children coupled with oral hygiene instructions. At the end of the session, participants were given a leaflet reinforcing the information to take home. | Behavioural | Conventional dental health education |
Primary outcome
Rate of dental plaque accumulation
Time frame: baseline
It was assesed using modified OHI-S.The presence of plaque was verified on the buccal surface of 6 index teeth: the upper right second deciduous molar (tooth 55), the upper right central deciduous incisor (tooth 51), the upper left second deciduous molar (tooth 65), the lower right second deciduous molar (tooth 85), the lower left central deciduous incisor (tooth 71), and the lower left second deciduous molar (tooth 75). According to the OHI-S, dental plaque is defined as a soft organic material loosely adhering to the tooth surface. The tooth surface covered by plaque was estimated by visual examination according to the following criteria: 0 =no plaque present; 1 = plaque covering no more than 1/3 of the surface in question; 2 = plaque covering more than 1/3, but no more than 2/3 of the surface; 3= plaque covering more than 2/3 of the surface; 9 = tooth excluded, no information.
Rate of dental plaque accumulation
Time frame: 6 months
It was assesed using modified OHI-S.The presence of plaque was verified on the buccal surface of 6 index teeth: the upper right second deciduous molar (tooth 55), the upper right central deciduous incisor (tooth 51), the upper left second deciduous molar (tooth 65), the lower right second deciduous molar (tooth 85), the lower left central deciduous incisor (tooth 71), and the lower left second deciduous molar (tooth 75). According to the OHI-S, dental plaque is defined as a soft organic material loosely adhering to the tooth surface. The tooth surface covered by plaque was estimated by visual examination according to the following criteria: 0 =no plaque present; 1 = plaque covering no more than 1/3 of the surface in question; 2 = plaque covering more than 1/3, but no more than 2/3 of the surface; 3= plaque covering more than 2/3 of the surface; 9 = tooth excluded, no information.
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 20 Aug 2020.
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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.
Amani Nomair, BDS principal investigator
Faculty of Dentistry, Alexandria University, Egypt
Maha Hamza, PhD study director
Faculty of Dentistry, Alexandria University, Egypt
Wafaa Essameldin, PhD study director
Faculty of Dentistry, Alexandria University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interviewing (MI), Gaming and MI and Conventional dental health education in people with Motivation, run by Nourhan M.Aly at 1 site in Egypt.
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 3 inclusion and 4 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 Aug 2020. 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 Egypt. 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?
Rate of dental plaque accumulation (time frame: baseline). The study lists 2 primary outcomes in all. 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 Aug 2020.