Pain, Pain Management
Conditions
Keywords
Pain management, Pediatric pain;, acupressure, anxiety, fair
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALacupressure
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.
OTHERcontrol (placebo) group
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.
Sponsors
Cukurova University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
Acupressure group
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
Yes
Inclusion criteria
\- Children aged 6-12 years. First-time K-wire removal following treatment for an elbow fracture. Able to communicate verbally and understand and speak Turkish. No chronic pain, psychiatric, developmental, or sensory disorders. No physical condition preventing acupressure application at the LI4 point. No opioid, narcotic analgesic, or sedative medication use within 8 hours before the procedure. Written informed consent obtained from both the child and parent after being informed about the study.
Exclusion criteria
* Neurological or psychiatric disorders that may affect pain perception. Developmental or sensory disabilities. Inability to communicate or cooperate during the procedure. Use of opioid, narcotic analgesic, or sedative medication within 8 hours before the procedure. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Outcome Measure-Pain | 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. |
| Anxiety assessed using the Child Anxiety Thermometeranxiety | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed