The Effects of Nonpharmacological Methods Used in Subcutaneous Application on Pain, Anxiety, and Fear Levels in Children

Condition(s) studied

Investigational drug(s) / intervention(s)

Kaleidoscope: Immediately before the procedure, children will be given the opportunity to examine the kaleidoscope and asked what shapes they see. The kaleidoscope distraction will begin immediately before the immunotherapy procedure and continue throughout the procedure. Children will be asked detailed questions such as, "What shapes do you see in the picture? What colors are there? How many eyes do you see in the picture?", which the child can only accurately answer after careful examination. After the procedure, the kaleidoscope will be wiped with 70% alcohol and preserved by the researcher for the next session. A Zapp Flex Kaleidoscope (31.5 cm) will be used in this study.

Buzzy: The device contains a wing-shaped ice pack on the skin-contact portion. The ice pack is stored in a deep freezer and inserted into the device before application. After application, the ice pack is wiped with 70% alcohol and kept in the freezer until it freezes again. Cold application and vibration begin before the procedure and continue until the end. When vibration is applied, it reduces or eliminates pain by causing numbness, paresthesia, and anesthesia. Cold application reduces pain by slowing or blocking conduction in peripheral nerves. It also reduces pain by activating the gate-control mechanism, stimulating touch receptors, and increasing the release of endogenous opioids.

Cognitive behavioral intervention: The researcher will suggest various distraction techniques (counting, singing, reading poetry, answering questions, etc.) to shift the child's focus during the procedure. The distraction technique chosen by the child will be used during the procedure. This method will be chosen during the preparation and briefing phases of the procedure. Cognitive behavioral intervention application will begin before subcutaneous application and will last 15-20 minutes, after which subcutaneous application will begin. After subcutaneous administration, children will rate their pain levels during and after the procedure with the Wong Baker Scale, their anxiety levels with the Children's State Anxiety Scale (CSA), and their fear levels with the Children's Fear Scale (CFS). A parent present with the child will observe the child's behavioral state during the procedure and will rate the child's fear level during and after the procedure with the CFS and their anxiety level with the CSA.

Study summary

Childhood cancers are increasing globally and require long-term invasive treatments, particularly subcutaneous applications that often cause pain, swelling, and anxiety. Effective pain and anxiety management is essential, as early traumatic experiences may shape children's future pain responses. Nonpharmacological methods-classified as physical, cognitive, and behavioral-are widely used alongside pharmacological strategies due to their safety, cost-effectiveness, and ease of application. Although studies show these methods reduce pain and anxiety, there is still a need for high-quality research comparing multiple approaches across different age groups and procedures. This study aims to evaluate and compare the effectiveness of combined physical, cognitive, and behavioral interventions in managing pain, anxiety, and fear among children with oncological diagnoses undergoing invasive procedures.

Eligibility

Primary outcome measure(s)

• Child Fear Scale and Child State Anxiety Scale — 5 minutes after the procedure
  This method is used to measure children's fear and anxiety. Children are shown pictures of five facial expressions, each scored between 0 and 4. A score of 0 indicates no fear or anxiety, while a score of 4 indicates the highest level of fear and anxiety. These are: * "0" represents a neutral expression (no anxiety) * "1" represents very little fear (very little anxiety) * "2" represents some fear (some anxiety) * "3" represents more fear (more anxiety) * "4" represents the highest level of fear (severe anxiety).
• Wong-Baker Faces Pain Rating Scale — 5 minutes after the procedure
  Six facial expressions are scored from left to right, from 0 to 5 (0 = very happy/no pain, 5 = most severe pain). As the score on the scale increases, pain tolerance decreases, and as the score decreases, tolerance increases. The child is asked to choose the face that best expresses their emotions.

Trial sites (1)