Clinical trial NCT06999759: Concealment of Chemotherapy Drug Serum With a Picture Box Effect on Anxiety, Nausea and Vomiting in Children
Official title: Concealment of Chemotherapy Drug Serum With a Picture Box Effect on Anxiety, Nausea and Vomiting in Children: A Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nursing Caries
Art Therapy
Keywords: Chemotherapy
Chemotherapy drug serum
Child
Anxiety
Nausea and Vomiting
Lead sponsor: Maltepe University
Sponsor class: OTHER
First posted: 2025-05-31
Enrollment: 70
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: SUPPORTIVE_CARE

Brief 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'.

Detailed description: Childhood cancers require intensive health care and have a high burden of disease. Childhood cancers have turned into a chronic disease that causes increasing physical and psychosocial symptoms all over the world and in our country, rather than a fatal disease, due to developments in multi-agent chemotherapy protocols, the use of targeted chemotherapeutic agents, intrathecal applications and supportive care.

Chemotherapy is accepted as the main treatment in childhood cancers. Symptoms related to chemotherapy in children diagnosed with cancer affect the continuity of treatment, life expectancy, morbidity, mortality and quality of life of the child.

In the literature review, studies on anxiety, depression and behavioural changes in the first year after diagnosis reported that anxiety was an important problem after diagnosis and the number of children scoring in the at-risk/clinical range of depression was high.

Nausea and vomiting is one of the most common symptoms in the treatment of childhood cancers. In studies, 60.9% of children receiving inpatient chemotherapy had nausea within one week after treatment. In a study on the presence, severity, risk factors and the effect on quality of life of symptoms related to nausea and vomiting in children with cancer in the first year of treatment, 41.8% and 42.9% of patients experienced nausea in the 3rd and 6th month after diagnosis, respectively.

İn the literature review, no study was found to reduce anxiety, nausea and vomiting symptoms of children diagnosed with cancer by using art therapy together with cognitive method during chemotherapy by taking into account the smell, appearance and previous negative experiences of chemotherapy serum drug.

In conclusion, cancer diagnosis, invasive interventions, long-term hospitalisation, long-term procedures, protocols and chemotherapy have negative effects on children.In this study, the effects of concealment of the drug serum during intravenous chemotherapy on anxiety, nausea and vomiting of children aged 5-10 years who are receiving chemotherapy for cancer will be compared. Art therapy, which is one of the therapeutic approaches during treatment, is aimed to improve the treatment process by diverting the child's attention and to change the negative feelings and thoughts caused by the smell, appearance, previous experiences of chemotherapy serum drug.

Eligibility criteria: 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.

Primary outcomes:
measure: . 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.]
Secondary outcomes:
measure: Change in nausea-vomiting thermometer scale (NVT) 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.
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Marmara Unıvesıty Educatıon And Research Hospıtal Istanbul, Pendik, Turkey, 34000 .
Study officials:
affiliation: Maltepe University School of Nursing İstanbul,Turkey
name: Gizem ERGÜN
role: PRINCIPAL_INVESTIGATOR
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