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

NCT ID: NCT07319806

Last Updated: 2026-01-06

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-15
• Study Completion Date: 2025-12-30

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.

Detailed Description

Procedural pain and fear are common challenges in pediatric clinical settings, particularly during invasive diagnostic procedures such as respiratory panel specimen collection. Children's negative emotional and behavioral responses during such procedures may lead to heightened distress, increased procedural resistance, and long-term fear of medical interventions. Therefore, the implementation of effective, safe, and developmentally appropriate non-pharmacological interventions is a priority in pediatric care.

This randomized controlled trial is designed to examine the comparative effectiveness of two tactile-based non-pharmacological interventions-a palm stimulator and a stress ball-on pain intensity, fear levels, and emotional behavior in children aged 6 to 12 years undergoing respiratory panel collection. The study adopts a parallel-group design with three arms: palm stimulator intervention, stress ball intervention, and routine care as the control condition.

Participants who meet the eligibility criteria will be randomly allocated to one of the three groups using a computer-generated randomization process. All respiratory panel specimen collections will be performed by the same trained pediatric nurse to minimize procedural variability. The interventions will be applied only during the specimen collection procedure, without altering standard clinical practice.

Pain, fear, and emotional responses will be assessed using validated pediatric measurement tools. Emotional behavior will be evaluated through structured behavioral observation before and after the procedure, while pain and fear will be assessed shortly after completion of the specimen collection. Assessments will be conducted by healthcare professionals who are not involved in the intervention delivery to reduce assessment bias.

By comparing two simple, low-cost, and easily applicable interventions with routine care, this study aims to generate evidence that can inform pediatric nursing practice and support the integration of non-pharmacological pain and fear management strategies into routine clinical procedures.

Conditions

Procedural Pain; Fear Anxiety; Children

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Palm Stimulator Intervention

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.

Group Type: EXPERIMENTAL

Palm Stimulator

Intervention Type: 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.

Stress Ball Intervention

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.

Group Type: EXPERIMENTAL

Stress Ball

Intervention Type: 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.

Routine Care Control Group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sakarya University

OTHER

Sponsor Role: lead

Responsible Party

Özge Karakaya Suzan

Asistant Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Düzce University

Düzce, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

palm stimulator

Identifier Type: -

Identifier Source: org_study_id