The Effect of Education Given to Parent… | Clinical Trial

Key information

Conditions

Hydrocephalus in Children

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pamukkale University Hospital

Denizli, 20180, Turkey (Türkiye)

About this study

This study aims to evaluate the effect of tele-education given to parents of children with ventriculoperitoneal shunt on their anxiety and self-efficacy. The type of research was planned as a prospective, randomized controlled experimental study with a pretest-posttest control group. The research will be conducted online with the parents of children with ventriküloperitoneal shunts at Pamukkale University Hospital. The data of the research will be collected between March 2024 and February 2025. In data collection, a personal information form will be used to determine the socio-demographic characteristics of the participants, a parent knowledge test will be used to evaluate their knowledge levels, and the General Self-Efficacy Scale and State and Trait Anxiety Scale will be used to evaluate the dependent variables. It was determined that 60 parents should participate in the study, 30 for the experimental group and 30 for the control group. As the randomization method, "simple randomization" will be used to ensure an equal number of samples in the experimental and control groups. Randomization will be done using the www.randomizer.org application. The data will be analyzed with the SPSS (23.0) package program. Continuous variables will be given as mean ± standard deviation and categorical variables will be given as number and percentage. Significance Test of Difference Between Two Means in comparing independent group differences when parametric test assumptions are met; When parametric test assumptions are not met, Mann-Whitney U test will be used to compare independent group differences.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Parent of a child aged 0-6 years with a VP shunt Able to access the internet Willing to participate Able to complete online questionnaires

Exclusion criteria

Difficulty accessing the internet Not participating in the online group Not responding to questionnaires Having a child older than 6 years with a VP shunt

Treatment and study plan

Tele-education and Counseling Program

Behavioral

A structured online behavioral program that provides video-based education and scheduled tele-counseling sessions for parents of children with ventriculoperitoneal (VP) shunts. The intervention includes educational modules, digital informational materials, and tele-counseling follow-ups delivered over a 3-month period.

Primary outcomes

State and Trait Anxiety Scale

Time frame: Two months

This inventory includes the State and Trait Anxiety Scales. Each contains 20 items. In State Anxiety, the options "Never", "Somewhat", "A lot", "Completely" are used, and in Trait Anxiety the options "Almost Never", "Sometimes", "Most of the Time", "Almost Always" are used. Weights of 1 in positive expressions are converted to 4, and weights of 4 in negative expressions are converted to 1. Certain items have reverse expressions and scoring is done accordingly. 10 items in State Anxiety and 7 items in Trait Anxiety contain reverse wording. For scoring, the scores of the reverse expressions are subtracted from the direct scores and fixed values (50 points for the state anxiety scale, 35 points for the trait anxiety scale) are added. The total score on both scales is between 20-80. A high score indicates high anxiety, a low score indicates low anxiety.

Secondary outcomes

General Self-Efficacy Scale

Time frame: Two months

The scale was created using a five-point Likert-type scale from 1 to 5 (1 = Not at all; 5 = Very Good) and contains 17 items in total. Items 2, 4, 5, 6, 7, 10, 11, 12, 14, 16 and 17 in the scale are evaluated by reverse scoring method. The research examines self-efficacy in terms of initiation (items 2, 4, 5, 6, 7, 10, 11, 12 and 17), resistance (items 3, 13, 14, 15 and 16) and maintenance effort-persistence (items 1, 16). It is analyzed in three different sub-dimensions: items 8 and 9).

Sponsors and collaborators

Lead sponsor

Pamukkale University

Other

Registry information

Official study title

The Effect of Tele-Education Provided to Parents of Children With Hydrocephalus and Ventriculoperitoneal Shunt on Their Anxiety and Self-Efficacy

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Mar 15, 2024
Registry last updated: Dec 10, 2025

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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Completed