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

NCT06999759 | Completed

• 1 other identifier: 2024/10-03
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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'.

Conditions

Nursing Caries; Art Therapy

Keywords

Chemotherapy; Chemotherapy drug serum; Child; Anxiety; Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

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

  It was determined 5 minutes before the planned therapeutic process and immediately after the end of the treatment with the ''Child Anxiety Scale-Situation Scale''.An increase in the scale score indicates an increase in the child's anxiety. The total score varies between 0-10 points.The lowest score that can be selected from the scale is ''0'' and the highest score is ''10''.

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

Secondary Outcomes (1)

• Change in nausea-vomiting thermometer scale (NVT) scores of the group receiving chemotherapy drug serum with picture box.

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

Study Arms (2)

group of cute serum boxes

EXPERIMENTAL

Children in the study group were provided with cute picture boxes with their own pictures hanging on them to receive chemotherapy.

Device: cute serum box; Other: coloring book and coloring pencils

Control Group

NO INTERVENTION

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.

Interventions

cute serum box DEVICE

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.

group of cute serum boxes

coloring book and coloring pencils OTHER

Children in the intervention group were provided with a coloring book and coloring pencils to make a picture to hang on the picture box.

group of cute serum boxes

Eligibility Criteria

• Age: 5 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maltepe University: lead

Study Sites (1)

Marmara Unıvesıty Educatıon And Research Hospıtal Istanbul, Pendik, Turkey, 34000 .

Istanbul, 34000, Turkey (Türkiye)

Location

Related Publications (13)

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  PMID: 33840271 BACKGROUND

• Çavuşoğlu, H. (2019). Çocuk Sağlığı Hemşireliği. Cilt 2, Ankara: Sistem Ofset Matbaacılık.

  BACKGROUND

• 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.

  PMID: 31307318 BACKGROUND

• 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.

  PMID: 30824204 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 38570307 BACKGROUND

• 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.

  PMID: 24473774 BACKGROUND

• 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.

  PMID: 31632842 BACKGROUND

• 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.

  PMID: 30587148 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 34544217 BACKGROUND

• 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.

  PMID: 28478846 BACKGROUND

• 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.

  PMID: 28888499 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Nausea; Vomiting

Condition Hierarchy (Ancestors)

Mental Disorders; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gizem ERGÜN

  Maltepe University School of Nursing İstanbul,Turkey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, PhD

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: May 31, 2025
• Study Start: October 3, 2024
• Primary Completion: November 10, 2024
• Study Completion: May 5, 2025
• Last Updated: May 31, 2025

Record last verified: 2025-05

Locations

TU (1)