Actively Recruiting

Phase Not Applicable
Age: 8Years - 10Years
All Genders
ID05263297

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

Led by Karamanoğlu Mehmetbey University · Updated on 2025-02-12

96

Participants Needed

2

Research Sites

21 weeks

Total Duration

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AI-Summary

What this Trial Is About

Researchers are investigating how two different cognitive-behavioral programs, one using video games and the other using a kaleidoscope, affect the pain, fear, and anxiety experienced by children during venous blood collection, as well as the satisfaction levels of their parents. This study includes children aged 8 to 10 years who visit a pediatric blood collection unit. The study is designed as a randomized controlled trial to compare these interventions and create a holistic approach to child health by evaluating both children and their parents. Children are randomly assigned to one of three groups: a control group with no intervention, a video game group where children play age-appropriate games on their parents' smartphones during blood collection, and a kaleidoscope group where children use a colorful kaleidoscope to distract themselves. The blood collection process is standardized and performed by the same experienced nurse using consistent techniques and materials. The interventions aim to provide visual and auditory distractions to reduce distress during the procedure. Participants and their parents will complete various assessments before and after the blood collection, including pain scales (Visual Analog Scale and Wong Baker Faces Pain Scale), fear and anxiety scales, and a parental satisfaction questionnaire. Data will be collected via face-to-face interviews and analyzed statistically. The study monitors children's responses during the procedure, and all data are kept confidential. Participation is voluntary, and children and parents can withdraw at any time. The primary outcomes measured are average fear score, pain score, and parents' satisfaction level within five minutes after the procedure.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 8Years - 10Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single session on blood collection day

Participants undergo venous blood collection while engaging in one of two cognitive-behavioral combined programs: playing an audio-visual video game or using a kaleidoscope to reduce pain, fear, and anxiety. Children in the control group receive no intervention during blood collection.

1 visit (in-person)

Follow-up

Duration - Approximately 5 minutes post-procedure

After the blood collection and intervention, participants are assessed for pain, fear, anxiety, and parents' satisfaction levels shortly after the procedure.

1 visit (in-person, immediately after blood collection)

Trial Site Locations

Total: 2 locations

1

KaramanogluMehmetbeyU

Karaman, Turkey (Türkiye), 70100

Actively Recruiting

2

Karamanoglu Mehmetbey University

Karaman, Turkey (Türkiye)

Completed

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Research Team

T

Turkmen

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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