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NCT Number: NCT05370131

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

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.

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Key information

Conditions

Developing the ABEP-H Brain Diseases Central Nervous System Diseases Determining the Effect of ABEP-H Hydrocephalus Nervous System Diseases

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Akdeniz University

Antalya, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Primary outcomes

  1. VP Shunt Complication Follow-up List (VP-CFL)

    Time frame: 1. month

    The VP Shunt Complication Follow-up List (VP-CFL) was based on a literature review conducted by the researchers. It consists of 24 parameters about shunt infection and dysfunction. These data will be provided from the patient file. The researcher will collect data on the other parameters during routine consultations and physical examinations. The follow-up of shunt complications in children will be done through this list.

  2. VP Shunt Complication Follow-up List (VP-CFL)

    Time frame: 3. months

    The VP Shunt Complication Follow-up List (VP-CFL) was based on a literature review conducted by the researchers. It consists of 24 parameters about shunt infection and dysfunction. These data will be provided from the patient file. The researcher will collect data on the other parameters during routine consultations and physical examinations. The follow-up of shunt complications in children will be done through this list.

  3. VP Shunt Complication Follow-up List (VP-CFL)

    Time frame: 6. months

    The VP Shunt Complication Follow-up List (VP-CFL) was based on a literature review conducted by the researchers. It consists of 24 parameters about shunt infection and dysfunction. These data will be provided from the patient file. The researcher will collect data on the other parameters during routine consultations and physical examinations. The follow-up of shunt complications in children will be done through this list.

  4. Hydrocephalus Knowledge and Care Skills Self-Assessment Scale

    Time frame: At the beginning of the research

    The researchers are developing the Hydrocephalus Knowledge and Care Skills Self-Assessment Scale (HKCSSAS). It is aimed to measure the knowledge and care skills of parents.The results of the pilot study showed that the scale was valid and reliable.

  5. Hydrocephalus Knowledge and Care Skills Self-Assessment Scale

    Time frame: 6. months

    The researchers are developing the Hydrocephalus Knowledge and Care Skills Self-Assessment Scale (HKCSSAS). It is aimed to measure the knowledge and care skills of parents.The results of the pilot study showed that the scale was valid and reliable.

Secondary outcomes

  1. Child and Parent Descriptive Questionnaire

    Time frame: At the beginning of the research

    The Child and Parent Descriptive Questionnaire (CPDQ) was based on a literature review conducted by the researchers. It consists of two parts. The first part consists of 10 items on children's sociodemographic characteristics and hydrocephalus. The second part consists of 13 items on parents' sociodemographic characteristics.

  2. System Usability Scale (SUS)

    Time frame: 6. Months

    The System Usability Scale (SUS) was developed by John Brooke and adapted to Turkish by Demirkol and Şeneler to measure the usability of products and services (hardware, software, mobile devices, websites, apps, etc.). The instrument consists of ten items rated on a five-point Likert-type scale (0: strongly disagree, 1: disagree, 2: undecided, 3: agree, 4: strongly agree). Five items (2, 4, 6, 8, and 10) are reverse scored. Each score is multiplied by 2.5 to convert to a scale of 0 to 100, where 100 represents the best possible usability.

Sponsors and collaborators

Lead sponsor

Akdeniz University

Other

Collaborators

  • The Scientific and Technological Research Council of Turkey

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
May 11, 2022
Registry last updated
Jan 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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