RecruitingNot ApplicableNCT05263297

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

The Effect of Two Different Cognitive-Behavioral Combined Programs in Blood Collection on Children's Pain, Fear and Anxiety and Parents' Satisfaction Level: A Randomized Controlled Study


Sponsor

Karamanoğlu Mehmetbey University

Enrollment

96 participants

Start Date

Apr 1, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 8 YearsMax Age: 10 Years

Plain Language Summary

Simplified for easier understanding

This study is testing two different methods to help reduce pain and fear in children aged 8–10 who need to have blood drawn. One method uses a video game as a distraction, and the other uses a kaleidoscope. Researchers want to find out which works better at keeping children calm. **You may be eligible if...** - Your child is between 8 and 10 years old and is coming in for a blood draw - Both the child and parent are willing to take part in the study - The child does not have a hearing or vision problem - The child and parent speak and understand Turkish - The child has a video game installed on the parent's phone - The blood draw is successful on the first attempt **You may NOT be eligible if...** - The child or parent does not want to participate - The child has taken a pain-relieving medication in the 6 hours before the procedure - The child's mental or physical development makes them unable to answer questions or play the game Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERcontrol group

no intervention will be made.


Locations(2)

KaramanogluMehmetbeyU

Karaman, Turkey (Türkiye)

Karamanoglu Mehmetbey University

Karaman, Turkey (Türkiye)

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NCT05263297


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