The Effect of an Avatar-Based Education Program on Shunt Complications and Parents' Knowledge and Care Skills

NCT ID: NCT05370131

Last Updated: 2024-01-30

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2024-01-28

Brief Summary

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Hydrocephalus is a common childhood neurosurgical disease. Ventriculoperitoneal (VP) shunt is usually used in the treatment of hydrocephalus. However, VP shunt may have some complications. In developed countries, the incidence of hydrocephalus is 1 per 1000 live births. In developing countries, it is 3-4 per 1000 live births. A multidisciplinary approach is important in the treatment and care of hydrocephalus. Parents need guidance and training for hydrocephalus treatment and care. Nurses should help parents solve all care-related problems. Technology-based nursing interventions have become popular in recent years because they make life easier for children with chronic diseases and their parents who should avoid non-emergency hospital visits during the COVID-19 pandemic. Investigators need innovative and interactive technology-based interventions to provide patients and their parents with the knowledge and skills necessary to manage chronic diseases. This study also focused on an avatar-based education program because avatars are interactive icons that provide intrinsic and extrinsic motivation for parents. Therefore Investigators develop an Avatar-based education program in Hydrocephalus (ABEP-H) and prove its effectiveness in reducing shunt complications and helping parents acquire the knowledge and develop the skills necessary for the care of their children with hydrocephalus.

Detailed Description

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Ventriculoperitoneal (VP) shunt is usually used in the treatment of hydrocephalus. However, VP shunt may have some complications. Children with shunts need good primary care.

There have been significant advances in science and technology in recent years. Therefore, education programs for patients and their parents also involve technology. The new face of technology in patient education is avatar-based education programs used to manage chronic diseases (cancer, diabetes, depression, etc.). However, this technology is underutilized in the training of pediatric patients. Therefore, this study will present a randomized controlled trial protocol to develop an avatar-based education program and determine its effect on shunt complications and parents' knowledge and care skills (ABEP-H).

The ABEP-H protocol adopted a single-blind, pretest-posttest, parallel-group (1:1 ratio), follow-up, multicenter randomized controlled experimental design. The intervention group will attend the ABEP-H for six months. Each intervention group participant will be phoned once every two weeks as a reminder. Data will be collected in the first, third, and sixth months.

The ABEP-H protocol will be based on the template for intervention description and replication (TIDieR) guideline and checklist. The protocol is designed according to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT). Randomized controlled trials (RCTs) are reported based on the Consolidated Standards of Reporting Trials (CONSORT).

Conditions

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Developing the ABEP-H Determining the Effect of ABEP-H

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Avatar-Based Education Program in Hydrocephalus (ABEP-H)

The avatar-based education program in hydrocephalus (ABEP-H) aimed to help parents acquire the knowledge and develop the skills necessary for the care of hydrocephalus children with VP shunts and prevent shunt infection and dysfunction. The intervention group participants will be sent usernames and passwords they can change by accessing their profiles. The main researcher will show them how to log into the program and use it on their phones and computers. This interview will take about 40 minutes. Afterward, they are expected to use the program for six months on a regular basis. Their login frequency and duration will be monitored. After six months, they will be asked to fill out the System Usability Scale (SUS). Moreover, each participant will be phoned once every two weeks as a reminder.

Group Type EXPERIMENTAL

Avatar-Based Education Program in Hydrocephalus (ABEP-H)

Intervention Type OTHER

The avatar-based education program in hydrocephalus (ABEP-H) aimed to help parents acquire the knowledge and develop the skills necessary for the care of hydrocephalus children with VP shunts and prevent shunt infection and dysfunction.

Control Group

The control group will receive the standard care procedures of the hospital.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Avatar-Based Education Program in Hydrocephalus (ABEP-H)

The avatar-based education program in hydrocephalus (ABEP-H) aimed to help parents acquire the knowledge and develop the skills necessary for the care of hydrocephalus children with VP shunts and prevent shunt infection and dysfunction.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Having a child with a VP shunt in the past six months
* No shunt infection
* Having a smartphone and mobile Internet access
* Speaking Turkish
* Understanding what is read and said
* Executing commands

Exclusion Criteria

* Not using the ABEP-H actively
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Scientific and Technological Research Council of Turkey

OTHER

Sponsor Role collaborator

Akdeniz University

OTHER

Sponsor Role lead

Responsible Party

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Mustafa Volkan DÜZGÜN

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ayşegül ISLER DALGIC, Prof

Role: STUDY_DIRECTOR

Akdeniz University

Mehmet Saim KAZAN, Prof

Role: STUDY_DIRECTOR

Akdeniz University

Locations

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Akdeniz University

Antalya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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221S685

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

KAEK-98

Identifier Type: -

Identifier Source: org_study_id

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