The Effect of Education Given to Parents of Children With Ventriculoperitoneal Shunt on Their Anxiety and Self-efficacy

December 3, 2025 updated by: Sevinc Aka, Pamukkale University

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

This study aims to evaluate the effect of tele-education given to parents of children with ventriculoperitoneal shunt on their anxiety and self-efficacy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: trained parent group
The experimental group will be given a total of 6 hours of training for 2 weeks, and they will be asked to fill out the State and Trait Anxiety Scale and the General Self-Efficacy Scale before and after the training. After 3 months of counseling, the scales will be filled in again.
Behavioral: Tele-education and Counseling Program
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.
No Intervention: uneducated parent group
The control group will be asked to fill out the State and Trait Anxiety Scale and the General Self-Efficacy Scale at the first interview. After 2 weeks, they will be asked to fill out the scales simultaneously with the experimental group, without any training. They will be asked to fill out the Parental Knowledge Test, State and Trait Anxiety Scale, and General Self-Efficacy Scale simultaneously with the experimental group, without any intervention for 3 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Two months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Two months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pamukkale University

Investigators

  • Principal Investigator: Türkan Turan Professor Doctor, Pamukkale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2024

Primary Completion (Actual)

February 15, 2025

Study Completion (Actual)

May 29, 2025

Study Registration Dates

First Submitted

March 10, 2024

First Submitted That Met QC Criteria

March 14, 2024

First Posted (Actual)

March 15, 2024

Study Record Updates

Last Update Posted (Actual)

December 10, 2025

Last Update Submitted That Met QC Criteria

December 3, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PamukkaleU-SBE-SA-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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