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

NCT07319806 | Enrolling By Invitation

• 1 other identifier: palm stimulator
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Procedural Pain; Fear Anxiety; Children

Keywords

Procedural Pain; Fear and Anxiety in Children; Palm Stimulator; Stress Ball; Emotional Behavior; Distraction Techniques; Pediatric Nursing

Outcome Measures

Primary Outcomes (3)

• Pain Intensity During Respiratory Panel 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.

  Within 5 minutes after completion of the respiratory panel specimen collection

• Fear Level During Respiratory Panel 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.

  Within 5 minutes after completion of the respiratory panel specimen collection

• Emotional Behavioral Response During Respiratory Panel 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.

  From 2-3 minutes before the procedure to 2-3 minutes after completion of the respiratory panel specimen collection

Study Arms (3)

Palm Stimulator Intervention

EXPERIMENTAL

Participants in this arm will hold a palm stimulator device in their hand during the respiratory panel specimen collection procedure. The device provides tactile stimulation through surface protrusions designed to activate sensory input. The palm stimulator will be used only during the procedure and removed immediately after completion.

Behavioral: Palm Stimulator

Stress Ball Intervention

EXPERIMENTAL

Participants in this arm will be provided with a stress ball during the respiratory panel specimen collection procedure. Children will be instructed to squeeze and release the stress ball repeatedly throughout the procedure as a distraction technique. The stress ball will be used only during the procedure.

Behavioral: Stress Ball

Routine Care Control Group

NO INTERVENTION

Participants in this arm will receive routine care during the respiratory panel specimen collection procedure without the use of any additional non-pharmacological intervention. Standard clinical practices, including caregiver presence and verbal reassurance, will be applied.

Interventions

Palm Stimulator BEHAVIORAL

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.

Palm Stimulator Intervention

Stress Ball BEHAVIORAL

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.

Stress Ball Intervention

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sakarya University: lead

Study Sites (1)

Düzce University

Düzce, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Procedural

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Only the outcome assessors responsible for scoring the observational measures and analyzing the study data are blinded to group allocation. Participants, caregivers, and the nurse delivering the intervention are not masked due to the visible nature of the non-pharmacological interventions.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asistant Doctor

Model Details: This study uses a parallel-group randomized design in which eligible participants are assigned to one of three study arms: palm stimulator intervention, stress ball intervention, or routine care (control). Each participant receives only one intervention during the respiratory panel collection procedure and does not cross over to another group throughout the study period.

Study Record Dates

• First Submitted: December 20, 2025
• First Posted: January 6, 2026
• Study Start: May 15, 2025
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: January 6, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)