The Effect of Occupation-Based Nursing Program Applied to Pediatric Oncology Patients

July 9, 2023 updated by: Sule ŞENOL, Akdeniz University

The Effect of Occupation-Based Nursing Program Applied to Pediatric Oncology Patients on Chemotherapy-Related Symptoms and Satisfaction

Nurses can include the child in their occupational activities by using the therapeutic communication techniques they have learned during their education. However, there is no occupation-based nursing program that is routinely implemented for children in pediatric clinics. Therefore, the aim of this study is to investigate the effect of occupation-based nursing program on increasing child satisfaction as well as reducing the symptoms of chemotherapy in pediatric oncology patients.

Study Overview

Status

Completed

Conditions

Detailed Description

Stressful processes that pediatric oncology patients may be exposed to in the hospital can have a negative effect on the child's anxiety, decrease in activities, and consequently recovery and participation in hospital care. These processes are very difficult for school children as well as for all children. Hospitalization becomes a limiting factor for the school-age child in this period when he is open to mental and physical development, and he starts to attach more importance to socialization and independence. In addition, problems such as painful diagnosis and treatment procedures, side effects of chemotherapy drugs, and insufficient activity support in the hospital may cause the child to stay away from activities. For these reasons, pediatric oncology patients spend their time in their rooms during chemotherapy treatments. With non-pharmacological approaches that can be applied to pediatric oncology patients, chemotherapy-induced symptoms such as fatigue, pain, anxiety and nausea can be reduced, as well as helping to spend the time in the hospital more enjoyable and active. In the studies conducted, it is stated that these approaches are mostly distracting methods. In this context, the use of distraction methods in nursing care is a valuable aspect of care. In our country, randomized controlled studies in which nurses use non-pharmacological methods are quite limited. With the increase of these studies, the use of effective non-pharmacological methods for pediatric oncology patients will be widespread. This study was planned to examine the effect of occupation-based nursing program (OBaNup) in pediatric oncology patients in reducing the symptoms of chemotherapy and on child satisfaction. In the experimental part of the study; It is planned to conduct a randomized controlled single blind experimental study with 60 pediatric oncology patients, including 30 interventions and 30 controls, who received chemotherapy treatment. It is planned to apply OBaNup to the initiative group for an average of 30 minutes a day for five days. Since there is no routine occupation-based nursing program applied to children in the clinic, it is thought that this study can contribute to both the literature and nursing practices. Therefore, in the planned study; It is predicted that OBaNup applied to pediatric oncology patients can reduce the symptoms of chemotherapy and increase satisfaction.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Konyaaltı
      • Antalya, Konyaaltı, Turkey, 7090
        • Şule Şenol

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 12 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 7-12 years old,
  • Inpatient treatment in Pediatric Hematology-Oncology service,
  • Children who can read and write in Turkish will be included in the study.

Exclusion Criteria:

  • Those who have visual or upper extremity impairment,
  • Mentally disabled,
  • Children in terminal period will not be included in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
Occupation-based nursing program

First Session (Rug Weaving Activity): The child and the caregiver will be informed about the purpose and process of the research. The researcher will show in detail how to use rug weaving materials. Rug weaving activity will be started with the child. At the end of the 30-minute practice, the second session with the child will be planned and the session will be ended.

Second Session (Rug Weaving Event Continues). Third Session (Rug Weaving Activity Continues): Rug weaving activity will be completed and the session will be ended by planning the fourth session with the child.

Fourth Session (Origami Activity): A figure will be made with origami with the child. The child will be given support to make another figure. The fifth session hour will be planned with the child and the session will be ended.

Fifth Session (Shape Making Activity with Chenille): A shape will be created with the child with chenille.

Experimental: Control Group
Routine nursing care
Routine nursing care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of chemotherapy-induced symptoms
Time Frame: at the baseline, immediately upon the completion of the program (fifth day), seven days after the intervention, and before discharge (14 days after the intervention)

Measured by Memorial Symptom Assessment Scale (7-12) is used to evaluate the symptoms of chemotherapy.

The scale is an 8-item scale used to evaluate the symptoms of pain, fatigue, sadness, nausea, itching, anxiety, change in taste, and insomnia experienced in the last two days by 7-12 year old children diagnosed with cancer. Symptoms are rated as 'present' or 'absent'. If symptoms are present, their duration is scored as "short duration (1 point)", "medium duration (2 points)" and "long duration (3 points)". The severity of the symptom is scored as "slight", "moderate", and "severe" in the same way as duration. The amount of distress caused by the symptom in the child is scored as "not at all (0 points)", "some (1 point), "moderate (2 points)" and "a lot (3 points)". It is 12. As the score obtained from the scale increases, it indicates that the negative effects of the symptom on the child increase.

at the baseline, immediately upon the completion of the program (fifth day), seven days after the intervention, and before discharge (14 days after the intervention)
Change of psychosocial symptoms for hospitalized children
Time Frame: at the baseline, immediately upon the completion of the program (fifth day), seven days after the intervention, and before discharge (14 days after the intervention)
Measured by Psychosocial Symptoms Diagnostic Scale for Hospitalized Children The scale developed to diagnose psychosocial symptoms for hospitalized children aged 6-12. Each statement in the 3-point Likert-type scale consisting of 24 items, which can be filled by the practitioner, was evaluated as "never", "sometimes" and "often" and scored as 0, 1 and 2, respectively. The highest score to be obtained from the scale is "48" and the lowest score is "0". A high score on the scale indicates that the child hospitalized in the clinic has psychosocial problems.
at the baseline, immediately upon the completion of the program (fifth day), seven days after the intervention, and before discharge (14 days after the intervention)
Change in satisfaction for hospitalized children
Time Frame: at the baseline, immediately upon the completion of the program (fifth day), seven days after the intervention, and before discharge (14 days after the intervention)
Measured by Child Satisfaction Form In the form prepared by the researchers in line with the literature, there are 10 questions to evaluate the satisfaction of the pediatric oncology patient. The form is in a five-point Likert type with the answers "I totally agree", "I somewhat agree", "I am undecided", "I do not agree" and "I do not agree at all". The minimum score that can be obtained from the form is 10 and the maximum score is 50. An increase in the scale score indicates that the child's satisfaction increases.
at the baseline, immediately upon the completion of the program (fifth day), seven days after the intervention, and before discharge (14 days after the intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2021

Primary Completion (Actual)

May 20, 2022

Study Completion (Actual)

October 30, 2022

Study Registration Dates

First Submitted

November 19, 2020

First Submitted That Met QC Criteria

January 12, 2021

First Posted (Actual)

January 14, 2021

Study Record Updates

Last Update Posted (Actual)

July 11, 2023

Last Update Submitted That Met QC Criteria

July 9, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • Akdeniz Unv

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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