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临床试验/NCT03670303
NCT03670303已完成不适用

Randomized, Controlled Trial of an Educational Intervention to Promote Spectacle Use Among Secondary School Children in Islamabad, Pakistan

Isra University16 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2018年9月27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
240
试验地点
16
主要终点
Purchase of Spectacles

研究概览

简要总结

This study is planned to test an educational intervention promoting the use of spectacles among secondary school children. It is based on the hypothesis that educating teachers, parents and children about the importance of wearing spectacles has the potential to increase spectacle wear among children.Reasons for non-compliance towards spectacle use will be explored and educational intervention will be planned considering these reasons. Educational intervention will increase awareness about the importance of spectacles use and reduce the barriers towards spectacle use.Reducing barriers will increase compliance towards spectacles use which will ultimately prevent the avoidable visual impairment.

详细描述

Aim of this research is to improve school performance and quality of life of children with refractive errors. Planned research will be carried out in eight (4 girls and 4 boys) Public Sector Secondary Schools of Islamabad and vision of students will be tested with standard snellen chart to recruit 120 boys and 120 girls with refractive errors. Students having vision ≤ 6/12 will receive auto refraction and prescription of spectacles will be given after subjective refraction. primary outcome of purchase of glasses will be asessed at three months after prescribing. Follow up after six months of prescribing spectacles will find out compliance towards spectacles. Non-compliant students will be given a questionnaire to provide the reasons for non-compliance towards spectacles. Focus Group Discussions (FGDs) will be conducted with non-compliant students, their teachers and parents to explore reasons of non compliance.

On the basis of information obtained from FGDs an educational intervention will be planned for students, their parents and teahers to explain importance of spectacles. Through stratified randomization schools will be assigned to intervention and control groups. Four schools including two girls and two boys schools will be assigned to intervention group and four schools (two girls and two boys) will be assigned to control group. Educational intervention will be given to intervention group. Six months after the intervention compliance to spectacle wear will be assessed than pre and post intervention compliance in intervention group and between two groups will be compared to assess effectiveness of intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

盲法说明

It is limitation of study that at base line data collection and data analysis masking is not possible as investigator has to do herself. Only outcome assessor can be masked to see how many students are using spectacles in intervention group and in control group. he will not be aware about type of groups.

入排标准

年龄范围
11 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 1- Children from 6th to 9th grade (approximate age, 11-16 years) of secondary schools in Islamabad.

排除标准

  • Children from 10th grade which is the final grade of secondary schools.
  • Children with eye disorders other than refractive error.

结局指标

主要结局

Purchase of Spectacles

时间窗: 3 months follow-up after baseline visit.

Observed wear or possession of purchased glasses.

次要结局

  • Wear of spectacles(6months and one year follow-up after baseline visit.)

研究者

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

Nusrat Nasim

PHD Scholar

Isra University

研究点 (16)

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