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临床试验/NCT06588062
NCT06588062已完成不适用

Effect of Picture Exchange Communication System in Improving Oral Hygiene Status Among Preschool Children with Autism Spectrum Disorder-A Randomized Controlled Trial

Dow University of Health Sciences2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
2
主要终点
Plaque Index (PI)

研究概览

简要总结

Background:

Oral health is an important part of overall health of the children and precisely it is additionally imperative for children who need out of the ordinary or special health care. Children with autism spectrum disorder normally face trouble in maintenance of good oral hygiene due to their incapacity to communicate and interact socially and are one such group lacking sufficient oral health knowledge to sustain their oral health owing to communication barriers.

Objective:

To assess and compare the effect of Picture Exchange Communication System (PECS) intervention on oral hygiene status of preschool children (aged 4 to 6 years old) with Autism Spectrum Disorder (ASD) over a period of three months.

Methods:

Children with confirmed diagnosis of autism will be randomly divided into two groups. All the participants of both the groups, intervention (Group I) and control (Group II) will receive conventional oral hygiene instructions in presence of their parents. These instructions will be given on model, showing each surface to be cleaned properly. Tooth brushing with the Horizontal Scrub Technique will be promoted and performance of brushing twice daily for 2 minutes. Moreover, instruction to avoid sugary diet will also be given. Additionally, the intervention participants (Group I) will be provided a set of 10 picture cards depicting brushing sequences and techniques by animated character for PECS intervention. The plaque scores will be recorded in the two groups by using PI index by Silness & Loe (1964), GI scores will also be recorded by using GI index Loe & Silness (1963) using a periodontal probe at baseline. Following the initial examination, oral health education will be given on model to both groups, in addition to this (Group I) will be demonstrated to use PECS intervention. After three months follow up visit will be conducted in which plaque and gingival scores will be recorded again in both groups to assess the impact of PECS intervention on oral hygiene status of children with ASD.

详细描述

RATIONALE OF STUDY The population with Autism Spectrum Disorder Syndrome (ASD) may require additional specific health needs due to their characteristic features. Among them especially children are at risk of many diseases due to major barriers that are found in improving health and wellbeing, because of lacking in health infrastructure in Pakistan. There is vast knowledge gap and very limited research is available on this subject specially when investigated in context of Pakistan. The scenario also worsens due to delayed diagnosis and treatment intervention to this population, whereas when it comes to dental needs major factors are responsible for its unmet treatment needs. The most important factors observed are lack of access to dental consultation, affordability and refraining treatment provision by dentist as these children are sensitive to many stimuli due to which their cooperation and management is usually compromised. This shows that it is essential to identify such existing voids and take remedial measures for it. Evidence based behavioral management approaches will be key to develop and improve compliance with oral health for patients with ASD. ASD children have difficulty in communication which leads to inability to interact socially. This is due to their altered behavior patterns which includes restricted, repetitive and stereotyped pattern of behavior. Due to behavioral issues there is lack of compliance to maintenance of oral health. As a result oral health is compromised and since the behavioral component makes them difficult to interact with the dentist, their treatment management also gets difficult. Hence focus should be done on prevention of oral diseases. PECS is an effective behavioral tool for teaching ASD children basic oral health maintenance techniques. In a low socioeconomic country like Pakistan where such disabled population is not given appropriate resources and workforce, improving oral health status of such population through a cost effective technique like PECS may help lower the burden of the disease from ASD children.

Since majority of studies have not been done as a case-control, interventional or prospective cohort, however most researches have not demonstrated or compared different technique / techniques nor mentioned the comparison in-between the technique, for instance the use of PECS with other conventional methods. Therefore, this study has been undertaken to carry out a randomized controlled trail, using blinding to keep the information and results as confidential and authentic as possible. For this reason, this research will compare PECS (test) with controls (conventional method) for providing a comparative analysis as well as provide most reliable evidence on the effectiveness of the intervention by minimizing risk of confounding factors which will influence the results.

STATEMENT OF PROBLEM Pakistan is considered as a Developing country with total population of 216.6 million as of 2019. Despite of huge population Pakistan is trying to improve different sectors in different aspects including health care delivery system. Unfortunately, the health sector framework and infrastructure is still delivering poor quality and working in inefficient manner at many different levels due to many reasons. Situation is found even worse for special population which includes people with disabilities, mental health issues, developmental and neurological disorder. Similarly, the scenario is not much differing for developmental and neurological disorder including ASD as well. This lacking is observed almost at every level of policy making and implementation. There is serious lacking in providing good institutions for their development, health, education and promotion. However, the scenario is same with oral health status and its promotion among autistic children in our country. Though the disorder is not rare but as compared to developed countries relatively little reflection and attention has been drawn towards it. Usually, the attention is not drawn because people affected with autism are subject to stigma and discrimination. As ASD children have difficulty in communication which leads to inability to interact socially due to their altered behavior patterns. Due to these communication and behavioral issues there is lack of compliance to maintenance of oral health. As a result oral health is compromised and since the behavioral component makes them difficult to interact and communicate with the dentist, their treatment management also gets difficult. Hence focus should be done on prevention of oral diseases. Picture Exchange Communication System is one widely used approach to communicate and develop skills in these children.

HYPOTHESIS:

Null Hypothesis (HO) There is no effect of Picture Exchange Communication System (PECS) on oral hygiene status of preschool children with Autism Spectrum Disorder (ASD)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
4 Years 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children with Confirmed diagnosis of ASD classified on the basis of CARS score 30-36.5 who understand visual or simple verbal instructions.
  • Age range between 4 to 6 years
  • Cooperative for oral examination

排除标准

  • ASD children with any systemic disease which can affect oral health.
  • Identification of any oral condition requiring immediate dental treatment.
  • Multiple disabilities, down syndrome, epilepsy patients.
  • Taking drugs such as anticonvulsant, antidepressants, anti-anxiety which can affect oral cavity tissues.

结局指标

主要结局

Plaque Index (PI)

时间窗: Three Month

The outcome measure will be evaluated in follow up examination after a period of three months by defining changes observed in PI scores calculated before and after intervention applied.

Gingival Index (GI)

时间窗: Three month

The outcome measures will be evaluated in follow up examination after a period of three months by defining changes observed in GI scores calculated before and after intervention applied.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Saqib Minhas

MDS Trainee

Dow University of Health Sciences

研究点 (2)

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