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Parental Presence and Preschoolers' Behavior

6 de outubro de 2020 atualizado por: Dina Youssef Attia, Alexandria University

Active/Passive Parental Presence Influences Behavior of Preschoolers With Different Intelligence and Fear Levels in the Dental Setting: Randomized Clinical Trial

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.

Visão geral do estudo

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Real)

150

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

      • Alexandria, Egito
        • Faculty of dentistry, Alexandria university

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

3 anos a 6 anos (Filho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  1. Age ranging from 3-6 years (the preoperational stage) (Piaget, 1954; 1966).
  2. Patients with no history of previous dental treatment and no history of dental pain.
  3. Patients with at least one sound quadrant for sealant application.
  4. Patients IQ level should be in the normal intelligence range.

Exclusion Criteria:

  1. Multiple dental problems with pain.
  2. History of previous dental therapy
  3. History of medical and psychological problems
  4. Any degree of intellectual disability

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Outro
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Experimental group
75 children were managed during intervention using 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.
Comparador de Placebo: control group
75 children were managed with passive parent 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

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Overall Behavior
Prazo: 1 month
Frankl's Behavior Rating Scale (FBRS) (Frankl, Shiere and Fogels, 1962) At the end of the second visit, after the application of preventive measures, each child overall behavior in each group was evaluated according to Frankl's Behavior Rating Scale (FBRS). It is a four group scale used to assess and evaluate the behavior of a child starting from Rating no. 1 (- -) with the most negative child behavior to Rating no. 4 (++) with the most positive child behavior.
1 month
Fear Measure
Prazo: 1 month

Facial Image Scale (FIS) (Buchanan and Niven, 2002) to account for fear state and is entered into the analysis as a confounder.

Dental fear was measured in the second visit by administration of Facial Image Scale (FIS). This measurement was done to every child in each group before the start of dental treatment. It is comprised of a row of five faces ranging from very happy face to very unhappy one. Children were asked to point at which face they feel most like at that moment. The face is scored by giving a value of one to the most positive affect face and five to the most negative affect face. The faces with 1 and 2 indicated a low dental fear , while the faces with the value of 4 and 5 indicated high dental fear

1 month

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Investigadores

  • Investigador principal: Karin M. Dowidar, PhD, Alexandria University

Publicações e links úteis

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Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

20 de dezembro de 2017

Conclusão Primária (Real)

1 de agosto de 2019

Conclusão do estudo (Real)

19 de agosto de 2019

Datas de inscrição no estudo

Enviado pela primeira vez

29 de setembro de 2020

Enviado pela primeira vez que atendeu aos critérios de CQ

6 de outubro de 2020

Primeira postagem (Real)

8 de outubro de 2020

Atualizações de registro de estudo

Última Atualização Postada (Real)

8 de outubro de 2020

Última atualização enviada que atendeu aos critérios de controle de qualidade

6 de outubro de 2020

Última verificação

1 de outubro de 2020

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • Parent active/passive presence

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

We will share the study protocol

Prazo de Compartilhamento de IPD

After 1 month and for 1 year

Critérios de acesso de compartilhamento IPD

Request access

Tipo de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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