CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 105 enrolled
Drug / intervention
Active Distraction +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06826352
NCT06826352N/ACompleted

The Effects of Active and Passive Distraction Methods on Children's Pain, Fear and Anxiety During Invasive Procedures: a Randomized Controlled Clinical Trial

Istanbul University - Cerrahpasa·interventional·Posted Feb 13, 2025·Updated Feb 13, 2025

In Brief

A clinical study evaluating Active Distraction and Passive Distraction for Pain and 2 related conditions. Completed, enrolled 105 participants across 1 site.

Detailed Summary

Background: It is important that reduce children's pain, fear, and anxiety during the invasive procedures for building effective communication with children and their parents. Knowing the effective methods will be helpful to use in the pediatric clinical. Objective: This study aimed to determine the effects of watching cartoons, a passive distraction method and playing video games, an active distraction method, on the pain, fear and anxiety of 3- to 7-year-old children before, during and after invasive procedures. Design: A randomized controlled clinical trial Setting(s): General pediatric service of a training and research hospital in Istanbul Participants: The study sample included 105 children who were 3- to 7-years-old inpatients. The children were randomly assigned to the control (n=35), cartoon (n=35) and video game (n=35) groups. Methods: The data were collected using an introductory information form, the Oucher Pain Scale, the Children's State Anxiety Scale, and the Children's Fear Scale between November 26, 2019 and January 8, 2020. Data analysis was performed with SPSS software using the chi-squared test, and one-way and repeated measures ANOVA.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain, Fear, Anxiety
CountriesTurkey (Türkiye)
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedFeb 13, 2025
Enrollment StartNov 26, 2019
Primary CompletionJan 8, 2020
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 1.4 years ago

Interventions

Active Distractionbehavioral

The video games will be played by children during the procedure.

Passive Distractionbehavioral

The cartoons will be selected by the children related to their interests. The cartoons are included Pepee, Niloya, Tom and Jerry, Masha and The Bear and others.