RecruitingNot Applicable

The Effect of Two Different Cognitive-Behavioral Combined Programs in Blood Collection

Turkey (Türkiye)96 participantsStarted 2022-04-01

Plain-language summary

The aim of this study is to investigate the effect of two different cognitive-behavioral combined programs, including video games or kaleidoscope, on the pain, fear and anxiety experienced by children who apply for therapeutic or diagnostic venous blood collection, and their parents' satisfaction levels. In addition, this research aims to create a holistic approach to child health due to the evaluation of both children and parents. The population of the research will be children aged 8-10 who come to the Children's Blood Collection Unit of Karaman Training and Research Hospital between February 2022 and March 2022. The sample of the study will consist of 96 children and their parents who applied to the Blood Collection Unit on the specified dates, met the inclusion criteria and agreed to participate in the study. The pediatric blood collection unit provides service between 08:00 and 16:00 on weekdays. In order to determine the number of samples, power analysis was performed using the G\*Power (v3.1.9) program. It was planned to carry out the research with a total of 96 children and their parents, 32 in each group, considering possible case losses during the research period. Evaluation of the data will be done in the computer environment with the SPSS (Statistical Package for Social Sciences) 22.0 package program. Percentage distributions, mean, standard deviation, chi-square test, analysis of variance will be used in the analysis of the data. In addition, the variance of the groups will be examined with the Levene test in order to make further analysis. In cases where the variance is equal, Bonferroni analysis will be used in post hoc advanced analyses, and Dunnett T3 analysis will be used in cases where the variance is not equal. The research findings will be evaluated at the 95% confidence interval, at the p\<0.05 significance level.

Who can participate

Age range

8 Years – 10 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Parents and children are willing to participate in the research, * Written and verbal consent of parents, verbal consent of children, * The child is in the 8-10 age group, * The child has come to the center to have blood drawn, * The child does not have a hearing or auditory problem, * Absence of pain, * The child and parent speak and understand Turkish comfortably, * The child's mental development level to be able to answer the questions asked, * Not using drugs that will create an analgesic effect in the last 6 hours before the application, * Children's cognitive level and motor development are suitable for playing video games or using a kaleidoscope, * Having a video game played by the child on the parent's phone, * Vascular access is made in one go, * Vascular access is performed by the same nurse Exclusion Criteria: * The child is not in the 8-10 age group, * The child has a hearing or auditory problem, * Having pain, * The child's and parent's inability to speak and understand Turkish comfortably, * The child is not at the level of mental development to be able to answer the questions asked, * Parents and children are not willing to participate in the research, * Parents do not give written and verbal consent, children do not give verbal consent, * To have used drugs that will create an analgesic effect in the last 6 hours before the application, * Children's cognitive level and motor development are not suitable for playing video games or using…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Fear average score

Timeframe: 5 minutes

Pain average score

Timeframe: 5 minutes

Parents' Satisfaction Level

Timeframe: 5 minutes

Trial details

NCT IDNCT05263297

SponsorKaramanoğlu Mehmetbey University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-04-30

Contact for this trial

Turkmen

+90505 378 1041 asonayturkmen@kmu.edu.tr

View on ClinicalTrials.gov More Child Behavior trials

Plain-language summary

Who can participate

Age range

8 Years – 10 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.