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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention
Behavioral: I Wonder What I Am Play
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dokuz Eylul University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 20, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 9, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 9, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 23, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 23, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 9, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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