Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 10:16 PM
Study NCT ID:
NCT07299058
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-23
First Post:
2025-12-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of a Guessing Game on Fear, Pain, and Emotional State During Blood Collection in Children Aged 6-12
Sponsor:
Dokuz Eylul University
Organization:
Study Overview
Official Title:
The Effect of a Guessing Game on Fear, Pain, and Emotional State During Blood Collection in Children Aged 6-12
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to evaluate the effects of a guessing game on fear, pain and emotional state during blood collection in children aged 6-12 years.
Detailed Description:
Invasive medical procedures, particularly blood draws, are among the most common healthcare procedures in which children experience intense fear, pain, and emotional stress. The literature contains numerous studies on distraction interventions designed to improve children's psychological well-being and reduce the traumatic effects of these procedures. However, the majority of these studies have focused on passive distraction techniques (e.g., watching videos or listening to music), with less emphasis on play-based interventions that involve active child participation (Uman et al., 2013; Koller \& Goldman, 2012). A meta-analysis by Birnie et al. (2018) demonstrated that distraction and techniques such as hypnosis are effective in reducing pain and anxiety associated with needle injections in children. Distraction-based approaches, in particular, have been reported to divert children's cognitive capacity from directing the procedure, leading to more positive emotional responses. A review of studies conducted in this area in Turkey reveals that methods such as distraction with music (Özdemir \& Karakoç, 2017), blowing bubbles (Karaman \& Selimen, 2015), and playing with toys have generally been evaluated. However, studies systematically examining play-based distraction practices that utilize children's cognitive functions such as decision-making, choice, and direction in the field of nursing are rare. A randomized controlled trial conducted by Hacettepe University found that a combination of information provision and an active distraction method (a tablet puzzle game) reduced both pain and fear levels in children (p=0.001-0.005) (Isıyel et al., 2023). Randomized controlled trials in the international literature demonstrate that playing video games, virtual reality, or using interactive technology (e.g., tablet games, VR modules) significantly reduces pain and anxiety during blood collection (Inan \& Inal, 2019). \| However, these studies often utilize passive or semi-passive distraction applications tailored to age, while predictive game designs that focus entirely on one-on-one interaction with the child are rarely featured in the literature. To this end, this study will evaluate the "Effect of a Guessing Game on Fear, Pain, and Emotional State During Blood Collection in Children Aged 6-12."
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: