The study is planned as a single-center, randomized experimental trial with two parallel intervention groups. The study population will consist of children aged 6-9 years for whom venous blood sampling is planned at Mersin University Hospital.
Hypotheses
* H1a: There is a difference between groups in mean WB-FACES scores during the procedure.
* H1b: There is a difference between groups in mean CFS scores during the procedure.
The sample size was calculated using a priori power analysis based on an effect size of d = 0.714 from Ugucu et al. (2022), with alpha = 0.05 and power = 0.80. The final sample is planned as 68 children, with 34 children in each intervention group.
Inclusion Criteria
* Being 6-9 years of age.
* Presenting to the Mersin University Hospital Pediatric Blood Collection Unit.
* Requiring and being scheduled for intravenous/venous blood sampling.
* Being able to speak Turkish and communicate. Exclusion Criteria
* Having a malignant or chronic disease.
* Having a developmental or sensory disability.
* Having a mental health problem.
* Lack of signed informed consent from the child's legal representative.
* Use of an opioid, narcotic analgesic, or sedative in the last 24 hours before the procedure.
Data Collection Instruments Child Information Form The Child Information Form, developed after a literature review, will include variables such as the child's age, sex, previous hospitalization and venous blood sampling experience, and the presence and frequency of invasive procedure experience in the last week and in the last month.
Wong-Baker FACES Pain Rating Scale The Wong-Baker FACES Pain Rating Scale is a valid and reliable measurement tool used to assess acute pain in children older than three years who can communicate. A score of 0 means no pain, and a score of 10 means unbearable/severe pain. According to scoring, 0-4 indicates mild pain, 5-6 moderate pain, 7-8 severe pain, and 9-10 unbearable pain. The approximate administration time is two minutes. Permission to use the scale was obtained by email.
Children's Fear Scale The Children's Fear Scale assesses pain-related fear in children. The scale was developed by McMurtry et al. (2011), and its Turkish validity and reliability study was conducted by Ozalp-Gerceker et al. (2018). The scale consists of five drawn facial expressions scored from 0 to 4, ranging from a neutral expression (0 = no anxiety/fear) to a fearful face (4 = severe anxiety/fear). In the validity and reliability study, the Content Validity Index was 0.89. Because the Children's Fear Scale is scored from 0 to 4, construct validity could not be performed. Test-retest reliability was very high (0.99). The cut-off point is 2; scores of 2 and above are considered high fear. The Children's Fear Scale is a valid and reliable measurement tool. Its approximate administration time is two minutes. Permission to use the scale was obtained from the author by email.
The Pediatric Blood Collection Unit is decorated with cartoon characters and ornaments. Only one child can undergo the procedure in the room at a time. Routine practice supports parental presence during all invasive procedures. Nurses routinely wear uniforms with cartoon-character prints/patterns. Environmental conditions such as lighting, temperature, noise, and seating are the same for all children and parents. The nurse who performs venous blood sampling will be the same for all groups and children and has five years of pediatric service experience.
Randomization and Allocation Concealment Block randomization will be used to preserve balance in participant numbers between groups. The randomization list will be generated by an independent statistician using simple random selection through randomizer.org. After block randomization, sequential numbers will be placed in closed opaque envelopes to conceal allocation. The final assignment of A and B codes to the intervention groups will be determined by drawing lots. Data will be entered using A and B codes, and group identities will be shared with researchers only after statistical analyses and the research report are completed.
Before the procedure, children will receive an explanation appropriate to their developmental level, and physical comfort will be ensured in the blood collection room. In the cartoon-watching group, the child will start watching a cartoon selected by the child two minutes before venous blood sampling begins. In the ball-squeezing group, the child will start squeezing a stress ball selected by the child two minutes before venous blood sampling begins. For both groups, the intervention will be terminated when venous blood sampling is completed. After the procedure, children will be given a star-shaped sticker as a gift.
Pain and pain-related fear scores will be recorded by the researchers two minutes before the procedure, during the procedure at the time of puncture, and one minute after the procedure. Data during and after the routine planned venous blood sampling procedure will be recorded by the researchers.
Statistical Analysis Plan Data will be analyzed using a statistical package program. The level of statistical significance will be set at 0.05. The Kolmogorov-Smirnov test will be used to assess normality of dependent variables. Chi-square tests and tests comparing means will be used to determine group similarity. Appropriate parametric or non-parametric tests will be used to compare between-group and within-group means depending on whether the distribution is normal. If differences are found between group means, an effect size appropriate to the test family will be used.
Ethics, Consent, and Assent The study will begin after obtaining ethics committee approval from the Mersin University Health Sciences Research Ethics Committee, written institutional permission, written informed consent from parents/legal representatives, and verbal assent from children.
