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

NCT05263297 | Recruiting

• 1 other identifier: Cognitive-Behavioral
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Child Behavior; Pain, Acute; Fear

Outcome Measures

Primary Outcomes (3)

• Fear average score

  children' fears before, during and after the procedure will be evaluated (0-4 point).

  5 minutes

• Pain average score

  children' pain before, during and after the procedure will be evaluated (0-4 point).

  5 minutes

• Parents' Satisfaction Level

  Parents' Satisfaction Level after the procedure will be evaluated (0-4 point).

  5 minutes

Study Arms (2)

video group

OTHER

During the bloodletting process, children in the video game group will be played with audio and visual video games that they can play with one hand. Thus, children will be provided with both visual and auditory stimuli. It will be preferred that children play the video game that they have knowledge about and know how to play the game. For this reason, children in the video game group will be given the chance to choose video games suitable for their age and development level on their parents' smartphones. These video games within the scope of the research will not be named and will not be promoted/advertised.

Other: control group

kaleidoscope group

OTHER

In this study, a kaleidoscope with colorful patterns that can be used by children with one hand will be used. In the research, the kaleidoscope will be introduced to children and how to use it will be explained. After the procedure, the kaleidoscope will be disinfected using appropriate disinfectant materials.

Other: control group

Interventions

control group OTHER

no intervention will be made.

kaleidoscope group; video group

Eligibility Criteria

• Age: 8 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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 a kaleidoscope,
• Not having a video game played by the child on the parent's phone,
• Vascular access cannot be performed in one go,
• Vascular access is not performed by the same nurse.

Sponsors & Collaborators

• Karamanoğlu Mehmetbey University: lead

Study Sites (2)

KaramanogluMehmetbeyU

Karaman, 70100, Turkey (Türkiye)

RECRUITING

Karamanoglu Mehmetbey University

Karaman, Turkey (Türkiye)

COMPLETED

MeSH Terms

Conditions

Child Behavior; Acute Pain

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Behavior; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Turkmen

CONTACT

+90505 378 1041; asonayturkmen@kmu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc.Prof.

Study Record Dates

• First Submitted: February 10, 2022
• First Posted: March 2, 2022
• Study Start: April 1, 2022
• Primary Completion: April 30, 2025
• Study Completion: September 30, 2025
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)