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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
59

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pamukkale University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 10, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 15, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 29, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 10, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 14, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 15, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 10, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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