UnknownNot Applicable

Effect of Toy and Mask Use on Pain and Anxiety in Children

Turkey (Türkiye)162 participantsStarted 2022-02-15

Plain-language summary

Invasive painful interventions such as diagnostic and therapeutic procedures, blood sampling, injection and vaccine administration are among the greatest fears of children and lead to undesirable experiences both in children and in parents and healthcare personnel due to children's reactions to pain (İnal \&Canbulat 2015;Tuna 2014; Wolyniez et al. 2013). It is important for healthcare personnel to spend additional time to manage the child's pain, anxiety and fear of medical procedures (Longobardi et al. 2019, Chen et al. 2020). The American Academy of Pediatrics and the American Pain Society recommend alleviating or minimizing stress and pain, including practices such as venipuncture (Özel \&Çetin 2020). Pharmacologic and nonpharmacologic techniques are applied to reduce the emotional and physical effects of painful intervention (Özel \&Çetin 2020). This study was planned to investigate the effect of the nurse's use of a mask with a cartoon character and the child's playing with a sound and light toy on the child's pain and parental anxiety during peripheral intravenous catheterization.

Who can participate

Age range

4 Years – 6 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: * The parent's verbal and written acceptance of the informed consent form, * The child has not been given any medication with analgesic effect in the last 6 hours, * Opening the vascular access on the first attempt, * Body temperature between 36.5-37.2⁰C, * The child does not have a chronic disease that requires frequent invasive procedures, * The child does not have a disease that can cause chronic pain, * The child does not have a mental or neurological disability that would affect participation in the research Exclusion Criteria: * Failure of the parent to verbally and in writing accept the informed consent form for participation in the study, * The child has taken a drug with analgesic, antipyretic, anti-inflammatory effect in the last 6 hours, * Failure to open the vascular access on the first attempt, * The child's body temperature is above 37.2⁰C, * Have a chronic disease that requires frequent invasive procedures, * The child has a disease that can cause chronic pain, * The child has an intellectual or neurological disability.

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

Change in children's pain level

Timeframe: 2 minutes before the procedure and 2 minutes after the procedure

Trial details

NCT IDNCT05892107

SponsorIstanbul University - Cerrahpasa

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-07-15

Contact for this trial

Songül OKŞAR

+90 +90 212 414 3000 songul.gezer@iuc.edu.tr

View on ClinicalTrials.gov More Intravenous Catheterization trials