NCT07097636

Brief Summary

The aim of this study was to evaluate the effects of video-based education provided to parents of children undergoing urodynamic testing on their State-Trait Anxiety Inventory and satisfaction levels. While some of the parents of children scheduled for urodynamic testing were shown a video, others were not. Anxiety and satisfaction levels were assessed in both groups before and after the procedure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable anxiety

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable anxiety

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

Study Start

First participant enrolled

July 5, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2024

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 23, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 31, 2025

Completed
Last Updated

July 31, 2025

Status Verified

July 1, 2025

Enrollment Period

6 months

First QC Date

July 23, 2025

Last Update Submit

July 30, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Parents' anxiety levels before the education

    Anxiety levels before the procedure will be assessed using the State-Trait Anxiety Inventory, which consists of 20 questions. Each question is scored from 1 to 4. A total score below 30 indicates low anxiety, a score between 31 and 45 indicates moderate anxiety, and a score of 46 or above indicates high anxiety. The urodynamic procedure will be performed according to routine clinical practice. High scores indicate high anxiety, while low scores indicate low anxiety.

    Immediately before procedurel]

  • Parents' anxiety levels after the education

    Parents in the control group will receive only verbal information, while parents in the study group will be given verbal education as well as shown a video. After the education, the anxiety levels of the parents will be assessed using the State-Trait Anxiety Inventory - State (STAI-S).

    Immediately after education

Secondary Outcomes (1)

  • Parental satisfaction levels regarding the video training

    Immediately after the education

Study Arms (2)

İntervention

EXPERIMENTAL

Video education

Other: Video education

No intervention

OTHER

Control group

Other: No intervention

Interventions

A video demonstrating the steps of the urodynamic procedure was shown, and afterward, participants' questions were answered by an experienced nurse who performed the procedure.

Also known as: İntervention group
İntervention

Children scheduled to undergo urodynamic testing for any reason received the procedure without any prior video-based education being provided to their parents

Also known as: Control group
No intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Parents must be at least 18 years old
  • have no intellectual disabilities or perception problems
  • have no communication difficulties.

You may not qualify if:

  • Insufficient proficiency in Turkish and unwillingness to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bursa Yüksek İhtisas Training and Research Hospital

Bursa, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety DisordersPersonal Satisfaction

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Mental DisordersBehavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 23, 2025

First Posted

July 31, 2025

Study Start

July 5, 2023

Primary Completion

January 5, 2024

Study Completion

January 5, 2024

Last Updated

July 31, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL
Time Frame
6 month

Locations