Clinical trial NCT05370131: The Effect of an Avatar-Based Education Program on Shunt Complications and Parents' Knowledge and Care Skills
Official title: The Effect of An Avatar-Based Education Program Developed For The Care Of Children With Ventriculoperitoneal Shunts On Shunt Complications And Parents' Knowledge And Care Skills: A Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Developing the ABEP-H
Determining the Effect of ABEP-H
Keywords: hydrocephalus
avatar-based education program
pediatric nursing
shunt complication
parents' knowledge and care skill
Lead sponsor: Akdeniz University
Sponsor class: OTHER
Collaborators: name: The Scientific and Technological Research Council of Turkey
First posted: 2022-05-11
Enrollment: 40
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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: 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).

Eligibility criteria: 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

Primary outcomes:
measure: VP Shunt Complication Follow-up List (VP-CFL)
timeFrame: 1. month
measure: VP Shunt Complication Follow-up List (VP-CFL)
timeFrame: 3. months
measure: VP Shunt Complication Follow-up List (VP-CFL)
timeFrame: 6. months
measure: Hydrocephalus Knowledge and Care Skills Self-Assessment Scale
timeFrame: At the beginning of the research
measure: Hydrocephalus Knowledge and Care Skills Self-Assessment Scale
timeFrame: 6. months
Secondary outcomes:
measure: Child and Parent Descriptive Questionnaire
timeFrame: At the beginning of the research
measure: System Usability Scale (SUS)
timeFrame: 6. Months
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Akdeniz University
Study officials:
affiliation: Akdeniz University
name: Ayşegül ISLER DALGIC, Prof
role: STUDY_DIRECTOR
affiliation: Akdeniz University
name: Mehmet Saim KAZAN, Prof
role: STUDY_DIRECTOR
References: