Clinical trial NCT04258748: Effect of Motivational Interviewing and Game Based Education on Oral Hygiene Behavior of Preschool Children
Official title: Effect of Motivational Interviewing and Game Based Education on Oral Hygiene Behavior of Preschool Children in Beheira Governorate, Egypt
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Motivation
Lead sponsor: University of Alexandria
Sponsor class: OTHER
Collaborators: name: Alexandria University
First posted: 2020-02-06
Enrollment: 174
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Rate of dental plaque accumulation
timeFrame: baseline
measure: Rate of dental plaque accumulation
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beheira
country: Egypt
facility: Governmental nurseries within Edko administration
Study officials:
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Amani Nomair, BDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Maha Hamza, PhD
role: STUDY_DIRECTOR
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Wafaa Essameldin, PhD
role: STUDY_DIRECTOR
References: