Trials / Completed
CompletedNCT04580316
Parental Presence and Preschoolers' Behavior
Active/Passive Parental Presence Influences Behavior of Preschoolers With Different Intelligence and Fear Levels in the Dental Setting: Randomized Clinical Trial
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 150 (actual)
- Sponsor
- Alexandria University · Academic / Other
- Sex
- All
- Age
- 3 Years – 6 Years
- Healthy volunteers
- Not accepted
Summary
Purpose: This study aimed to assess the effect of parental active/passive presence technique (PAP/PPP) on the overall behavior of preschool children with different intelligence and fear levels. Methods: This randomized controlled trial recruited 150 healthy children, 3-6 years old, with no history of previous dental pain/treatment, IQ level ≤70 to ≤110. After sample collection, in the first visit, children were stratified according to their Intelligence Quotient into 3 equal groups (high, average, low) in which each group was further equally and randomly divided into 2 sub-groups (test and control). In the second visit, before intervention with preventive measures, dental fear was assessed using facial image scale. During intervention, the control sub-groups were managed using PPP technique, while the test sub-groups were managed using PAP technique. Overall behavior was assessed using Frankl behavior rating scale at the end of the 2nd visit. Data was analyzed using chi-square test and logistic regression analysis. Results: The PAP technique had significantly higher odds of positive behavior than the PPP technique (P=0.002). Conclusions: Children with low intelligence showed higher dental fear and negative behavior in the dental setting. PAP technique had significant positive effect on the children's overall behavior with different fear and intelligence levels.
Detailed description
The design of the study was a randomized controlled clinical trial with an allocation ratio of 1:1. Children enrolled in this study were stratified based on their IQ into three groups; high, average and low IQ groups. In each of these three groups, children were randomly and equally allocated into study and control subgroups. Thus, this study included 6 subgroups. \- Visual Screening and History taking were carried out to identify children who fulfilled the inclusion criteria. Parental meeting was also conducted to explain the child entire research plan. The children were recruited from the Outpatient clinic of Pediatric Dentistry Department in Faculty of Dentistry at Alexandria University. The IQ test for each selected child took place in a quiet closed room (special need clinic). The preventive measures were applied in the pediatric clinic of the department. \- Interventions In the first visit, children who fulfilled the inclusion/ exclusion criteria were evaluated by IQ test then divided into 3 equal groups (50 children) according to their level of intelligence IQ as follows: 1. High IQ Children group (HIQ): with score of (110 and above) 2. Average IQ Children (AIQ): with score of (90-109) 3. Low IQ Children (LIQ)(with the normal intelligence range): with score of (70-89) In the second visit, fear was measured in each group followed by random allocation into test and control subgroups and then the implementation of the intervention. * In each group (50 children), 25 children in subgroup S (study group) were managed using Parental Active Presence (PAP) technique, while the other 25 children in subgroup C (control group) were managed using Parental Passive Presence (PPP) technique. Parental Active / Passive Presence technique was accompanied with Tell-Show-Do (TSD) Technique (Addelston, 1959). During this management, dental preventive measures were applied.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Parental active presence | The parents were allowed to stand close to their children, do handholding, eye contacting and help in explaining the dentist's instructions. |
| BEHAVIORAL | Parent passive presence | Parents were instructed to sit silently in the dental clinic behind the patient with no eye contact, and without a spoken word only to reassure their children |
Timeline
- Start date
- 2017-12-20
- Primary completion
- 2019-08-01
- Completion
- 2019-08-19
- First posted
- 2020-10-08
- Last updated
- 2020-10-08
Locations
1 site across 1 country: Egypt
Source: ClinicalTrials.gov record NCT04580316. Inclusion in this directory is not an endorsement.