- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07299058
The Effect of a Guessing Game on Fear, Pain, and Emotional State During Blood Collection in Children Aged 6-12
December 9, 2025 updated by: İlknur Bektaş, Dokuz Eylul University
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
70
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Being between 6 and 12 years of age
- Not having a previous diagnosis of a serious hematological/psychiatric disease
- The child and parent must be willing to participate in the study
- Being able to speak and understand Turkish
Exclusion Criteria:
- Having received sedation, analgesics, or anxiolytic medication during the procedure
- Having a visual/hearing impairment
- Having previously undergone an invasive procedure on the same day
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
|
I Wonder What I Am: This is a board game designed to help children over the age of four develop mental, cognitive, and language skills.
The game consists of colorful cards with objects (animals, objects, vehicles, etc.) and a tool for placing them on the head.
This tool begins with placing the object card to be guessed in the appropriate location, unseen by anyone else, and explaining the object's characteristics, followed by questions.
|
|
No Intervention: Control
Control group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Pain assessment will be measured using a pain scale. The scale is scored from 0 to 10. The higher the score, the greater the pain.
Time Frame: Months 1-2 of the study
|
Months 1-2 of the study
|
|
Fear assessment will be measured using a fear scale. The scale is scored from 0 to 4. Higher scores indicate higher fear.
Time Frame: Months 1-2 of the study
|
Months 1-2 of the study
|
|
Emotional outlook assessment will be measured using the Emotional State Scale. The scale is scored from 5 to 25. Higher scores indicate higher negative emotional states.
Time Frame: Months 1-2 of the study
|
Months 1-2 of the study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
December 20, 2025
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Study Registration Dates
First Submitted
December 9, 2025
First Submitted That Met QC Criteria
December 9, 2025
First Posted (Actual)
December 23, 2025
Study Record Updates
Last Update Posted (Actual)
December 23, 2025
Last Update Submitted That Met QC Criteria
December 9, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DokuzEU-7
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
After the study is completed, it is planned to be shared in accordance with the permission given by the ethics committee.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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