CompletedNot Applicable

Comparison of the Effect of Two Different Interventions

Turkey (Türkiye)90 participantsStarted 2023-10-01

Plain-language summary

The goal of this clinical trial is to compare the effect of two different non-pharmacologic interventions with the control group in reducing pain due to peripheral intravenous catheterization application in children aged 5-12 years. Hypotheses: H1: Pain level differs in the group that received PIK with Palm Stimulator compared to the control group. H2: The level of fear in the group with PIK application with Palm Stimulator differs from the control group. H3: Satisfaction level is different in the group with PIK application with Palm Stimulator compared to the control group. H4: The pain level differs in the group that received PIK application by watching cartoons compared to the control group. H5: The level of fear is different in the group that received PIK application by watching cartoons compared to the control group. H6: Satisfaction level is different in the group that received PIK application by watching cartoons compared to the control group. H7: Pain level is different in the Palm Stimulator PIK group compared to the cartoon group. H8: The level of fear is different in the Palm Stimulator PIK group compared to the cartoon group. H9: The satisfaction level in the group with PIK application with Palm Stimulator is different from the cartoon group. H10: PIK application time is different in the palm stimulator group compared to the control group. H11: PIK application time is different in the cartoon group compared to the co

Who can participate

Age range

5 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

. Voluntary participation in the study,
. Pediatric patients for whom written and verbal consent has been obtained from the parent,
. Pediatric patients for whom verbal consent was obtained,

Exclusion criteria

. Not volunteering to participate in the study,
. More than one PIK attempt,
. Children with a chronic, acute, or life-threatening illness.

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

Pain Measurement

Timeframe: 3 months

Fear

Timeframe: 3 months

Trial details

NCT IDNCT06772259

SponsorSakarya University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-01

View on ClinicalTrials.gov More To Compare the Effect of Two Different Nonpharmacological Methods on Pain and Fear During Peripheral Intravenous Catheterization trials