Clinical Trials Directory

Trials / Completed

CompletedNCT06999759

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

Concealment of Chemotherapy Drug Serum With a Picture Box Effect on Anxiety, Nausea and Vomiting in Children: A Prospective Randomized Controlled Study

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
70 (actual)
Sponsor
Maltepe University · Academic / Other
Sex
All
Age
5 Years – 10 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEcute serum boxAfter the children in the intervention group were made to draw pictures, they were glued to the designed cute serum box and chemotherapy drug serum was hidden and they were provided to receive their treatment.
OTHERcoloring book and coloring pencilsChildren in the intervention group were provided with a coloring book and coloring pencils to make a picture to hang on the picture box.

Timeline

Start date
2024-10-03
Primary completion
2024-11-10
Completion
2025-05-05
First posted
2025-05-31
Last updated
2025-05-31

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT06999759. Inclusion in this directory is not an endorsement.