Hydrocephalus in ChildrenNCT06313879
The Effect of Education Given to Parents of Children With Ventriculoperitoneal Shunt on Their Anxiety and Self-efficacy
A study testing Tele-education and Counseling Program in people with Hydrocephalus in Children, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hydrocephalus in Children
- What is being tested?
- Tele-education and Counseling Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Mar 2024to 29 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Hydrocephalus in Children
- Being tested
- Tele-education and Counseling Program
- Keywords
- online education, ventriculoperitoneal shunt, hydrocephalus in children, self sufficiency, parental anxiety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele-education and Counseling ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Two months
Secondary outcomes (1)
General Self-Efficacy Scale
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).
Measured: Two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start10 Mar 2024
- Primary completion15 Feb 2025
- Study completion29 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hydrocephalus in ChildrenStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups: comparative experiment and control
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevinc Aka, Pamukkale University
- Investigators
- Türkan Turan Professor Doctor, Principal investigator, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06313879
- Sponsor's protocol ID
- PamukkaleU-SBE-SA-01
- Status last verified
- Dec 2025
- First submitted
- 10 Mar 2024
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Tele-Education Provided to Parents of Children With Hydrocephalus and Ventriculoperitoneal Shunt on Their Anxiety and Self-Efficacy
- ClinicalTrials.gov ID
- NCT06313879
- Acronym / sponsor ID
- PamukkaleU-SBE-SA-01
- Conditions
- Hydrocephalus in Children
- Keywords
- online education, ventriculoperitoneal shunt, hydrocephalus in children, self sufficiency, parental anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 10 Mar 2024 (actual)
- Primary completion
- 15 Feb 2025 (actual)
- Study completion
- 29 May 2025 (actual)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the effect of tele-education given to parents of children with ventriculoperitoneal shunt on their anxiety and self-efficacy.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Two groups: comparative experiment and control
| Arm | Type | Receives |
|---|---|---|
| trained parent group | Experimental | Behavioral: Tele-education and Counseling ProgramThe 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. |
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tele-education and Counseling ProgramA 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. | Behavioural | trained parent group |
Primary outcome
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.
1 secondary outcome
General Self-Efficacy Scale
Time frame: Two months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Türkan Turan Professor Doctor principal investigator
Pamukkale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tele-education and Counseling Program in people with Hydrocephalus in Children, run by Pamukkale University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State and Trait Anxiety Scale (time frame: Two months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.