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Enrolling by invitation Not applicable

The Effect of Two Different Interventions on Emotional State, Pain, and Fear During Respiratory Panel Removal in Children: A Randomized Controlled Study

NCT07319806 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2025-05-15
Last updated
2026-01-06

Condition(s) studied

Procedural PainFear AnxietyChildren

Investigational drug(s) / intervention(s)

Palm StimulatorStress Ball

Palm Stimulator: Children will be instructed to hold the palm stimulator in the palm of their hand during the respiratory panel specimen collection procedure and to squeeze/grip it throughout the procedure as a tactile distraction strategy. The palm stimulator will be used only during the procedure and removed immediately after completion.

Stress Ball: Children will be given a stress ball during the respiratory panel specimen collection procedure and will be instructed to repeatedly squeeze and release the ball throughout the procedure as an active distraction technique (e.g., counting while squeezing). The stress ball will be used only during the procedure.

Study summary

Respiratory panel collection is a commonly used diagnostic procedure in children with suspected respiratory tract infections; however, it is often perceived as painful and distressing. Inadequately managed pain and fear during such procedures may negatively affect children's emotional responses to future medical interventions.

This randomized controlled trial aims to evaluate and compare the effects of two non-pharmacological interventions-a palm stimulator and a stress ball-on pain, fear, and emotional behavior in children aged 6-12 years undergoing respiratory panel specimen collection. Participants will be randomly assigned to one of three groups: palm stimulator intervention, stress ball intervention, or routine care (control group).

Pain, fear, and emotional responses will be assessed using validated pediatric measurement tools before, during, and after the procedure. The findings of this study are expected to contribute evidence on simple, practical, and developmentally appropriate non-pharmacological strategies that can be safely integrated into pediatric nursing practice to improve children's procedural experiences.

Eligibility

Sex
ALL
Min age
6 Years
Max age
12 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Children aged 6 to 12 years * Hospitalized children scheduled for respiratory panel specimen collection * Ability to communicate verbally, understand instructions, and follow commands * Children not receiving sedative, anticonvulsant, or analgesic medications at the time of the procedure * Written informed consent obtained from a parent or legal guardian * Assent obtained from the child * Willingness of the child and parent/legal guardian to participate in the study Exclusion Criteria: * Children who do not consent or assent to participate * Children requiring more than one attempt for respiratory panel specimen collection * Presence of chronic, acute, or life-threatening medical conditions * Children with cognitive or communication impairments that prevent reliable assessment * Children with dependence on electronic or technological devices that may interfere with the intervention

Primary outcome measure(s)

  • Pain Intensity During Respiratory Panel Collection — Within 5 minutes after completion of the respiratory panel specimen collection
    Pain intensity will be assessed using the Wong-Baker FACES Pain Rating Scale. Children will rate the maximum level of pain experienced during the respiratory panel specimen collection procedure shortly after completion of the procedure. Higher scores indicate greater pain intensity.
  • Fear Level During Respiratory Panel Collection — Within 5 minutes after completion of the respiratory panel specimen collection
    Fear level will be measured using the Children's Fear Scale (CFS). Children will self-report their level of fear related to the respiratory panel specimen collection immediately after the procedure. Higher scores reflect greater fear.
  • Emotional Behavioral Response During Respiratory Panel Collection — From 2-3 minutes before the procedure to 2-3 minutes after completion of the respiratory panel specimen collection
    Emotional behavioral responses will be evaluated using the Children's Emotional Manifestation Scale. Behavioral observations will be conducted by a blinded outcome assessor before and after the respiratory panel specimen collection. Higher total scores indicate more negative emotional and behavioral responses.

Trial sites (1)

FacilityCityRegionStatus
Düzce University Düzce Turkey (Türkiye)
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07319806 on ClinicalTrials.gov ↗ ← All trials in Turkey