CompletedNot Applicable

Concealment of Chemotherapy Drug Serum With a Picture Box Effect on Anxiety, Nausea and Vomiting in Children

Turkey (Türkiye)70 participantsStarted 2024-10-03

Plain-language summary

The aim of this study was to present the results of the effect of concealing chemotherapy drug serum with a picture box on children's anxiety, nausea and vomiting. The study was planned with children aged 5-10 years who met the inclusion criteria. In this randomised controlled study, 70 children with cancer who are hospitalised in Marmara University Hospital and meet the inclusion criteria will be divided into two equal groups. The first group (intervention group) receives chemotherapy in chemotherapy boxes in which pictures made by the children are pasted before starting chemotherapy. In the second group (control group), children do not draw and chemotherapy boxes are not used. In both groups, the'' Child Anxiety Scale - State Anxiety Scale'' and the' Nausea - Vomiting Thermometer Scale in Children with Cancer'' will be used to assess children's state anxiety and nausea and vomiting. The scores given by the children will be noted by the researcher and the observer 5 minutes before the treatment and immediately after the end of the treatment in the scale scores section of the 'Child monitoring and evaluation form during chemotherapy'.

Who can participate

Age range

5 Years – 10 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: * 5-10 years old (The scale used is between this age group, these children should be willing to draw and should be suitable for their developmental periods) * Inpatients with cancer, * Those receiving the second and subsequent courses of chemotherapy, * Previous chemotherapy experience, * Those receiving chemotherapy drugs, the duration of chemotherapy lasting an average of 1 to 6 hours * Those taking chemotherapy drugs with minimal, low and moderate severity of nausea and vomiting, * Children whose parents agreed to participate in the study were included in the study. Exclusion Criteria: * Those in the last stage of cancer (experiencing the side effects of treatment intensively during hospitalisation due to the disease and symptoms causing complications) * Those receiving oral chemotherapy, * Those who experience intense side effects of chemotherapy (febrile neutropenia, bleeding, allergic reactions), * People with mental problems (depression, anxiety disorders, disruptive behaviour disorders, neurodevelopmental disorders), * People on antidepressant medication, * Those who have a physical disability (e.g. amputation, lack/inability to use arms, hands and fingers, visual or hearing impairment, etc.) to paint during chemotherapy, and * Children taking medicines with high severity of nausea and vomiting were not included in the study.

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

. The change in child anxiety scale state scale (CAS-D) scores of the group receiving chemotherapy drug serum with picture box

Timeframe: 5 minutes before the start of chemotherapy medication and immediately after the end of treatment.]

Trial details

NCT IDNCT06999759

SponsorMaltepe University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-11-10

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