Concealment of Chemotherapy Drug Serum With a Picture Box Effect on Anxiety, Nausea and Vomiting in Children
NCT ID: NCT06999759
Last Updated: 2025-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
70 participants
INTERVENTIONAL
2024-10-03
2025-05-05
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
group of cute serum boxes
Children in the study group were provided with cute picture boxes with their own pictures hanging on them to receive chemotherapy.
cute serum box
After 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.
coloring book and coloring pencils
Children in the intervention group were provided with a coloring book and coloring pencils to make a picture to hang on the picture box.
Control Group
The chemotherapy drug serum of the children in the control group was not concealed by the designed picture box, and they continued their treatment routinely.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
cute serum box
After 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.
coloring book and coloring pencils
Children in the intervention group were provided with a coloring book and coloring pencils to make a picture to hang on the picture box.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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.
5 Years
10 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Maltepe University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Behice Ekici
Associate Professor, PhD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Gizem ERGÜN
Role: PRINCIPAL_INVESTIGATOR
Maltepe University School of Nursing İstanbul,Turkey
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Marmara Unıvesıty Educatıon And Research Hospıtal Istanbul, Pendik, Turkey, 34000 .
Istanbul, , Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Saeidzadeh S, Kamalumpundi V, Chi NC, Nair R, Gilbertson-White S. Web and mobile-based symptom management interventions for physical symptoms of people with advanced cancer: A systematic review and meta-analysis. Palliat Med. 2021 Jun;35(6):1020-1038. doi: 10.1177/02692163211006317. Epub 2021 Apr 12.
Çavuşoğlu, H. (2019). Çocuk Sağlığı Hemşireliği. Cilt 2, Ankara: Sistem Ofset Matbaacılık.
Withycombe JS, Haugen M, Zupanec S, Macpherson CF, Landier W. Consensus Recommendations From the Children's Oncology Group Nursing Discipline's State of the Science Symposium: Symptom Assessment During Childhood Cancer Treatment. J Pediatr Oncol Nurs. 2019 Jul/Aug;36(4):294-299. doi: 10.1177/1043454219854983.
Ward ZJ, Yeh JM, Bhakta N, Frazier AL, Atun R. Estimating the total incidence of global childhood cancer: a simulation-based analysis. Lancet Oncol. 2019 Apr;20(4):483-493. doi: 10.1016/S1470-2045(18)30909-4. Epub 2019 Feb 26.
Tripathi, A. K., David, A., Govil, T., Rauniyar, S., Rathinam, N. Κ., Goh, K. M., Sani, R. K. (2020). Environmental Remediation of Antineoplastic Drugs: Present Status, Challenges, and Future Directions. Processes, 8(7), 747. doi:10.3390/pr8070747.
Nie Y, Tian Y, Han X. Music Nursing as Complementary Therapy Improves Anxiety, Fatigue, and Quality of Life in Children with Acute Leukaemia: A Retrospective Study. Noise Health. 2024 Jan-Mar 01;26(120):25-29. doi: 10.4103/nah.nah_33_24. Epub 2024 Mar 23.
Myers RM, Balsamo L, Lu X, Devidas M, Hunger SP, Carroll WL, Winick NJ, Maloney KW, Kadan-Lottick NS. A prospective study of anxiety, depression, and behavioral changes in the first year after a diagnosis of childhood acute lymphoblastic leukemia: a report from the Children's Oncology Group. Cancer. 2014 May 1;120(9):1417-25. doi: 10.1002/cncr.28578. Epub 2014 Jan 28.
Hu H, Shear D, Thakkar R, Thompson-Lastad A, Pinderhughes H, Hecht FM, Lown EA. Acupressure and Therapeutic Touch in Childhood Cancer to Promote Subjective and Intersubjective Experiences of Well-being During Curative Treatment. Glob Adv Health Med. 2019 Sep 30;8:2164956119880143. doi: 10.1177/2164956119880143. eCollection 2019.
Braam KI, van Dijk-Lokkart EM, Kaspers GJL, Takken T, Huisman J, Buffart LM, Bierings MB, Merks JHM, van den Heuvel-Eibrink MM, Veening MA, van Dulmen-den Broeder E. Effects of a combined physical and psychosocial training for children with cancer: a randomized controlled trial. BMC Cancer. 2018 Dec 27;18(1):1289. doi: 10.1186/s12885-018-5181-0.
Gerçeker, G. Ö., Ayar, D., Özdemir, Z., ve Bektaş, M. (2018). Çocuk Anksiyete Skalası-Durumluluk ve Çocuk Korku Ölçeğinin Türk Diline Kazandırılması. Dokuz Eylül Üniversitesi Hemşirelik Fakültesi Elektronik Dergisi, 11(1), 9-13.
Akdeniz Kudubes A, Bektas M. Developing the Nausea and Vomiting Thermometer Scale in children with cancer. Turk J Med Sci. 2022 Feb;52(1):166-174. doi: 10.3906/sag-2005-88. Epub 2022 Feb 22.
Altay N, Kilicarslan-Toruner E, Sari C. The effect of drawing and writing technique on the anxiety level of children undergoing cancer treatment. Eur J Oncol Nurs. 2017 Jun;28:1-6. doi: 10.1016/j.ejon.2017.02.007. Epub 2017 Mar 2.
Aguilar BA. The Efficacy of Art Therapy in Pediatric Oncology Patients: An Integrative Literature Review. J Pediatr Nurs. 2017 Sep-Oct;36:173-178. doi: 10.1016/j.pedn.2017.06.015. Epub 2017 Jun 30.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2024/10-03
Identifier Type: -
Identifier Source: org_study_id