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

NCT07163104 | Active Not Recruiting DMC

• 1 other identifier: 25/03
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pediatric Oncology

Keywords

Childhood cancer; Pain management; Anxiety; Invasive procedures; Subcutaneous injections; Nonpharmacological interventions; Nursing care; Pediatric oncology

Outcome Measures

Primary Outcomes (2)

• Child Fear Scale and Child State Anxiety Scale

  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).

  5 minutes after the procedure

• Wong-Baker Faces Pain Rating Scale

  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.

  5 minutes after the procedure

Study Arms (3)

Kaleidoscope

EXPERIMENTAL

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.

Behavioral: Kaleidoscope

Buzzy

EXPERIMENTAL

For children in this group, a Buzzy device will be placed on the treatment area 60 seconds before the subcutaneous application begins, and cold and vibration will be applied. At the end of this period, the nurse will slide the Buzzy device approximately 3 cm above the treatment area, and the procedure will be performed. The Buzzy device will continue throughout the procedure, and once the procedure is complete, the Buzzy device will be removed. 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.

Behavioral: Buzzy

Cognitive behavioral intervention

EXPERIMENTAL

It consists of four components: procedural preparation and information, cognitive distraction, suggestions and caregiver education (cognitive components), and cognitive distraction and positive reinforcement (behavioral components).

Behavioral: Cognitive behavioral intervention

Interventions

Kaleidoscope BEHAVIORAL

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.

Kaleidoscope

Buzzy BEHAVIORAL

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.

Buzzy

Cognitive behavioral intervention BEHAVIORAL

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.

Cognitive behavioral intervention

Eligibility Criteria

• Age: 6 Months - 14 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 6-14 years,
• Have an oncological diagnosis,
• Have received at least one chemotherapy treatment before,
• And whose parents are willing to participate in the study will be included in the study.

You may not qualify if:

• Children with any visual, auditory, verbal, or cognitive impairment,
• Those in the terminal stages of their illness,
• Those with a history of sedative, analgesic, or narcotic use within 24 hours of admission,
• Those with a febrile illness or history of infection at the time of admission,
• Those with a score of 2 or higher on the Wong-Baker Pain Scale independent of the procedure (during the pre-procedure assessment),
• Those who do not complete the study will not be included in the study.

Sponsors & Collaborators

• Zubeyde Ezgi Ercelik: lead

Study Sites (1)

Zonguldak Bulent Ecevit University Training and Research Hospital

Zonguldak, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neoplasms; Agnosia; Anxiety Disorders

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 1, 2025
• First Posted: September 9, 2025
• Study Start: February 10, 2025
• Primary Completion: October 10, 2025
• Study Completion: December 1, 2025
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)