NCT07299058

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
8mo left

Started Dec 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress37%
Dec 2025Dec 2026

First Submitted

Initial submission to the registry

December 9, 2025

Completed
11 days until next milestone

Study Start

First participant enrolled

December 20, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 23, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

December 23, 2025

Status Verified

December 1, 2025

Enrollment Period

1 year

First QC Date

December 9, 2025

Last Update Submit

December 9, 2025

Conditions

Keywords

painfearemotional statechildren

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    Months 1-2 of the study

Study Arms (2)

Intervention

EXPERIMENTAL
Behavioral: I Wonder What I Am Play

Control

NO INTERVENTION

Control group

Interventions

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.

Intervention

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Academic staff

Study Record Dates

First Submitted

December 9, 2025

First Posted

December 23, 2025

Study Start

December 20, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

December 23, 2025

Record last verified: 2025-12