PainNCT07299058
The Effect of a Guessing Game on Fear, Pain, and Emotional State During Blood Collection in Children Aged 6-12
A study testing I Wonder What I Am Play in people with Pain and Blood Sampling Procedure, run by Dokuz Eylul University.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Blood Sampling Procedure, Fear Anxiety
- What is being tested?
- I Wonder What I Am Play
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 20 Dec 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
Read the 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."
- Conditions
- Pain, Blood Sampling Procedure, Fear Anxiety
- Being tested
- I Wonder What I Am Play
- Keywords
- pain, fear, emotional state, children
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I Wonder What I Am PlayBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Behavioral: I Wonder What I Am Play |
| Control | No intervention | Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Months 1-2 of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start20 Dec 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study was designed as a randomized controlled experimental trial. There will be one intervention group and one control group. The intervention and control groups will receive a pretest, followed by the planned interventions during the blood draw. The control group will receive routine care. Both groups will receive posttests after the intervention.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İlknur Bektaş, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07299058
- Sponsor's protocol ID
- DokuzEU-7
- Status last verified
- Dec 2025
- First submitted
- 9 Dec 2025
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: After the study is completed, it is planned to be shared in accordance with the permission given by the ethics committee.
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Guessing Game on Fear, Pain, and Emotional State During Blood Collection in Children Aged 6-12
- ClinicalTrials.gov ID
- NCT07299058
- Acronym / sponsor ID
- DokuzEU-7
- Conditions
- Pain, Blood Sampling Procedure, Fear Anxiety
- Keywords
- pain, fear, emotional state, children
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 20 Dec 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 23 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study was designed as a randomized controlled experimental trial. There will be one intervention group and one control group. The intervention and control groups will receive a pretest, followed by the planned interventions during the blood draw. The control group will receive routine care. Both groups will receive posttests after the intervention.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: I Wonder What I Am Play |
| Control | No intervention | –Control group |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| I Wonder What I Am PlayI 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. | Behavioural | Intervention |
Primary outcome
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Individual participant dataSharing planned: Undecided. After the study is completed, it is planned to be shared in accordance with the permission given by the ethics committee.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing I Wonder What I Am Play in people with Pain and Blood Sampling Procedure, run by Dokuz Eylul University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.