The Effect of Two Different Interventions on Emotional State, Pain, and Fear During Respiratory P… (NCT07319806) | Clinical Trial Compass
By InvitationNot Applicable
The Effect of Two Different Interventions on Emotional State, Pain, and Fear During Respiratory Panel Removal in Children: A Randomized Controlled Study
Turkey (Türkiye)35 participantsStarted 2025-05-15
Plain-language 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.
Who can participate
Age range
6 Years – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pain Intensity During Respiratory Panel Collection
Timeframe: Within 5 minutes after completion of the respiratory panel specimen collection
2
Fear Level During Respiratory Panel Collection
Timeframe: Within 5 minutes after completion of the respiratory panel specimen collection
3
Emotional Behavioral Response During Respiratory Panel Collection
Timeframe: From 2-3 minutes before the procedure to 2-3 minutes after completion of the respiratory panel specimen collection