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临床试验/NCT04709653
NCT04709653已完成不适用

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

Akdeniz University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年6月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Change of psychosocial symptoms for hospitalized children

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

盲法说明

The control and intervention group will be formed by randomization. The intervention and control group will be defined as group 1 and group 2 for statistical analysis. Data analysis will be evaluated and reported by the statistician. Also the statistician will be blind.

入排标准

年龄范围
7 Years 至 12 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

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

研究组 & 干预措施

Intervention Group

Experimental

Occupation-based nursing program

干预措施: Occupation-based nursing program (Other)

Control Group

Experimental

Routine nursing care

干预措施: Control Group (Other)

结局指标

主要结局

Change of psychosocial symptoms for hospitalized children

时间窗: 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.

Change of chemotherapy-induced symptoms

时间窗: 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.

Change in satisfaction for hospitalized children

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sule ŞENOL

Research assisstant

Akdeniz University

研究点 (1)

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