Effects of cognitive-behavioral programs on children's pain and anxiety during 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
This study tests if using video games or a kaleidoscope can help reduce pain and anxiety for kids aged 8-10 during blood draws, while also looking at how their parents feel about the experience.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 96 (estimated) |
| Ages | 8 Years to 10 Years |
| Sex | All |
| Sponsor | Karamanoğlu Mehmetbey University Academic / other |
| Locations | 2 sites (Karaman and 1 other locations) |
| Trial ID | NCT05263297 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of two cognitive-behavioral programs, one utilizing video games and the other a kaleidoscope, on the pain, fear, and anxiety experienced by children aged 8-10 during venous blood collection. It also assesses the satisfaction levels of their parents. The research employs a randomized controlled experimental design and includes 96 children and their parents who meet specific inclusion criteria. The study aims to provide a holistic approach to child health by evaluating both children and their parents' experiences.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 8-10 who are scheduled for venous blood collection and can understand and participate in the study.
Not a fit: Patients who may not benefit include those outside the 8-10 age range, those with hearing problems, or those experiencing pain.
Why it matters
Potential benefit: If successful, this study could significantly reduce pain and anxiety in children undergoing blood collection, improving their overall experience and satisfaction.
How similar studies have performed: Other studies have shown success with cognitive-behavioral approaches in managing pain and anxiety in pediatric populations, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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.
Where this trial is running
Karaman and 1 other locations
- KaramanogluMehmetbeyU — Karaman, Turkey (Türkiye) (Recruiting)
- Karamanoglu Mehmetbey University — Karaman, Turkey (Türkiye) (Completed)
Study contacts
- Study coordinator: Turkmen
- Email: asonayturkmen@kmu.edu.tr
- Phone: +90505 378 1041
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.