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临床试验/CTRI/2024/10/076017
CTRI/2024/10/076017
尚未招募
不适用

Effect of customized oral health awareness program on knowledge and practice of oral hygiene maintenance among institutionalized visually impaired people of Lucknow city A prospective interventional study

King Georges Medical University1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2024年11月18日最近更新:

概览

阶段
不适用
状态
尚未招募
发起方
King Georges Medical University
入组人数
150
试验地点
1
主要终点
Visually impaired people encounter some challenges for their oral health. Using this study, we may be able to compare the effectiveness of oral health education using audio alone, audio with Braille and audio with art package (models) On oral health status of visually impaired people.

概览

简要总结

This study aims to assess and compare the impact of a customized oral health awareness program on the knowledge and practices of visually impaired individuals in Lucknow. The program involves three methods: audio alone, audio with Braille, and audio with model techniques. Participants’ oral health knowledge and practices will be evaluated at four intervals: baseline, 30 days, 90 days, and 180 days. The goal is to identify which method is most effective in improving oral hygiene among this population. A cluster randomized design will be used, with a minimum sample size of 180 participants. Statistical analyses, including T-tests and chi-square tests, will be applied to compare results, and effect sizes will be calculated to measure the magnitude of the differences. Confounding variables will be controlled, and subgroup analyses will be conducted to explore variations in intervention effects. The study aims to determine the best approach for promoting oral hygiene in visually impaired individuals, improving their overall well-being.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant Blinded

入排标准

年龄范围
10.00 Year(s) 至 40.00 Year(s)(—)
性别
All

入选标准

  • bilateral (total/partial) visual impairment, compliance and cooperation of oral examination by patients, parental/self acceptance.

排除标准

  • serious medical conditions requiring priority treatment, patient/parents who do not cooperate.
  • patient/parent who do not provide informed consent.

结局指标

主要结局

Visually impaired people encounter some challenges for their oral health. Using this study, we may be able to compare the effectiveness of oral health education using audio alone, audio with Braille and audio with art package (models) On oral health status of visually impaired people.

时间窗: baseline, 30 days, 90 days, 180 days

次要结局

  • The secondary outcomes of the study include assessing long-term retention of oral health knowledge and improvements in oral hygiene practices among visually impaired individuals at intervals of 30, 90, and 180 days. The study will also evaluate changes in oral hygiene status using the OHI-S index, comparing the effectiveness of different teaching methods—Audio alone, Audio with Braille, and Audio with Model. Additionally, participant and institutional satisfaction with the programs will be assessed, along with the effectiveness of weekly reinforcement in enhancing knowledge retention and practices. Finally, intergroup comparisons will be made to determine the most effective learning approach.(baseline, 30 days, 90 days, 180 days)

研究者

发起方
King Georges Medical University
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Mohit Kumar Kanoujia

King Georges Medical University

研究点 (1)

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