An interventional study of Palm Stimulator and Stress Ball in Procedural Pain, Fear Anxiety and Children, sponsored by Sakarya University. Enrolling by invitation at 1 site in Turkey (Türkiye). Open to participants aged 6 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-06.
Sponsored by Sakarya University · Not applicable, Interventional, and Supportive care
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.
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.
241 studies on the registry are indexed under Pain, Procedural; 64 are open to participants now.
This study's planned enrollment of 35 is below the median of 90 across 227 interventional studies indexed under Pain, Procedural.
Browse Pain, Procedural studies →Sakarya University is the lead sponsor of 190 studies on the registry; 53 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: From 2-3 minutes before the procedure to 2-3 minutes after completion of the respiratory panel specimen collection
Plan to share: No
No publications or documents are linked to this record.
Started May 2025 (actual). Primary completion is estimated for Dec 2025, 7 months after the start.
Of 141 non-industry interventional studies with no phase under Pain, Procedural, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 15. This study's planned 7 months is close to that.
Counting every sponsor, half of 141 studies reached it within 7 months; a quarter within 3 and three quarters within 15.
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