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

NCT ID: NCT03670303

Last Updated: 2021-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-27

Study Completion Date

2020-02-12

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Refractive Errors Visual Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Study will involve two groups intervention group and no intervention (control) group. each group will include two boys and two girls schools. Educational intervention will be given to two boys and two girls schools. Remaining two boys and two girls schools will not receive educational intervention. Simultaneous follow-ups will be carried out in two groups to assess compliance towards spectacles use.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

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Intervention group

This group will include randomly selected two boys and two girls schools. Vision screening and refraction will be carried out at base line.Compliance will be assessed at 6 months follow-up after baseline assessment than educational intervention will be given. Six months after intervention compliance will be assessed again.

Group Type EXPERIMENTAL

Educational intervention

Intervention Type BEHAVIORAL

Educational intervention will be given by trained optometrists to participants (requiring spectacles) their parents and teachers. Duration of Intervention will be about one hours and it includes:

1. Lectures on importance of spectacles use including visual materials such as pictures and videos.
2. An interactive classroom based demonstration carried out by trained optometrist. Children will be asked to read from blackboard, written to be visible with 6/6 vision, while seated at a distance of 6m. After this children will be given their glasses and asked to read again. The purpose of this demonstration is to make children aware of their poor vision and of the potential impact of corrected VA.
3. Posters
4. Brochures

Control group

This group will also include randomly selected two boys and two girls schools. Vision screening and refraction will be carried out at base line.Compliance towards spectacle use will be assessed at 6 months after baseline assessment. No intervention will be given in this group. Compliance will be assessed again at the same time when assessed in intervention group 6 months after the intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Educational intervention

Educational intervention will be given by trained optometrists to participants (requiring spectacles) their parents and teachers. Duration of Intervention will be about one hours and it includes:

1. Lectures on importance of spectacles use including visual materials such as pictures and videos.
2. An interactive classroom based demonstration carried out by trained optometrist. Children will be asked to read from blackboard, written to be visible with 6/6 vision, while seated at a distance of 6m. After this children will be given their glasses and asked to read again. The purpose of this demonstration is to make children aware of their poor vision and of the potential impact of corrected VA.
3. Posters
4. Brochures

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Children from 10th grade which is the final grade of secondary schools.
2. Children with eye disorders other than refractive error.
Minimum Eligible Age

11 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Isra University

OTHER

Sponsor Role lead

Responsible Party

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Nusrat Nasim

PHD Scholar

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shaista Habibullah, PhD

Role: STUDY_DIRECTOR

Director (Tech)

Locations

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Islamabad Model School for Boys G-11/2

Islamabad, , Pakistan

Site Status

Islamabad Model School for Boys I-10/2

Islamabad, , Pakistan

Site Status

Islamabad Model School for Boys I-8/4

Islamabad, , Pakistan

Site Status

Islamabad Model School for Boys I-9/4

Islamabad, , Pakistan

Site Status

Islamabad Model School for Girls 1-10/4

Islamabad, , Pakistan

Site Status

Islamabad Model School for Girls F-6/1

Islamabad, , Pakistan

Site Status

Islamabad Model School for Girls F-7/2

Islamabad, , Pakistan

Site Status

Islamabad Model School for Girls G-7/1

Islamabad, , Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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IIRS-IUISB/1602-PHD-005

Identifier Type: -

Identifier Source: org_study_id

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