Van Yuzuncu Yıl University
Van, Tuşba, 65080, Turkey (Türkiye)
NCT Number: NCT07775547
This study aims to evaluate pain in children during and after K-wire (Kirschner wire) removal and to investigate the effect of the intervention on pain. Children who are scheduled for K-wire removal will be included in the study. Participants will be assigned to an intervention group or a control group. Pain intensity will be assessed using the Visual Analog Scale (VAS), scored from 0 to 10. Pain assessments will be performed before and after the procedure. In addition to the child's pain rating, pain will also be assessed by the parent and the researcher. The pain scores will be compared to evaluate differences between the groups and changes in pain before and after the procedure.
This study is active but is not currently recruiting participants.
Notify Me6 year–12 year
All sexes
Interventional
Not applicable
Van, Tuşba, 65080, Turkey (Türkiye)
This study is designed to evaluate pain associated with K-wire (Kirschner wire) removal in children and to compare pain outcomes between an intervention group and a control group. Children who meet the study eligibility criteria and are scheduled for K-wire removal will be included.
Participants will be assigned to an intervention group or a control group according to the study protocol. Pain intensity will be assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst possible pain). Pain will be assessed immediately before and after K-wire removal.
Pain assessments will be obtained independently from three perspectives: the child, the parent, and the researcher. The agreement among these three assessments will also be evaluated.
The primary purpose of the study is to determine whether the intervention is associated with a greater reduction in pain compared with the control condition. Pain scores before and after the procedure will be compared within and between the study groups.
The findings of this study may contribute to a better understanding of pain management during K-wire removal in children and may help inform clinical approaches for reducing procedural pain.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Written informed consent obtained from both the child and parent after being informed about the study.
Exclusion criteria
Requirement for analgesic or sedative medication during the procedure. K-wire removal not completed in a single session. Complications during the procedure, such as prolonged or traumatic K-wire removal.
Wound, infection, dressing, fracture, inflammation, or other local contraindications at the LI4 acupressure site.
Withdrawal of informed consent by the child or parent during the study
Participants in the placebo group will receive a touch procedure at the LI4 acupressure point without therapeutic acupressure stimulation. Pain will be assessed during and after K-wire removal. Anxiety and fear will be assessed before, during, and after the procedure.
Participants in the control group will receive a placebo acupressure procedure. Pressure will be applied to a location distant from the LI4 acupressure point, without stimulating the therapeutic LI4 point. Pain will be assessed during and after K-wire removal, while anxiety and fear will be assessed before, during, and after the procedure.
Time frame: Baseline and 2 hours
Pain intensity will be assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst possible pain). Pain scores will be assessed during and after K-wire removal.
Time frame: Baseline and 2 hours
Anxiety level will be assessed using the Child Anxiety Thermometer, a visual analog scale ranging from 0 (no anxiety) to 10 (very high anxiety). Anxiety scores will be assessed before, during, and after K-wire removal.
Cukurova University
Other
THE EFFECT OF ACUPRESSURE ON PAİN, FEAR, ANXİETY, AND PHYSİOLOGİCAL PARAMETERS DURİNG KİRSCHNER WİRE REMOVAL İN CHİLDREN: A RANDOMİZED CONTROLLED TRİAL
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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