NCT06313879

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

March 10, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 15, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 29, 2025

Completed
Last Updated

December 10, 2025

Status Verified

December 1, 2025

Enrollment Period

11 months

First QC Date

March 10, 2024

Last Update Submit

December 3, 2025

Conditions

Keywords

online educationventriculoperitoneal shunthydrocephalus in childrenself sufficiencyparental anxiety

Outcome Measures

Primary Outcomes (1)

  • State and Trait Anxiety Scale

    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 Outcomes (1)

  • General Self-Efficacy Scale

    Two months

Study Arms (2)

trained parent group

EXPERIMENTAL

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

uneducated parent group

NO INTERVENTION

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.

Interventions

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.

trained parent group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamukkale University Hospital

Denizli, 20180, Turkey (Türkiye)

Location

Study Officials

  • Türkan Turan Professor Doctor

    Pamukkale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Two groups: comparative experiment and control
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 10, 2024

First Posted

March 15, 2024

Study Start

March 10, 2024

Primary Completion

February 15, 2025

Study Completion

May 29, 2025

Last Updated

December 10, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations