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临床试验/NCT03753542
NCT03753542已完成不适用

Effect of Nurse-led Education on Parent's Anxiety and Depression on Managing Side Effects of Chemotherapy

Nomi Waqas Gul1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年9月6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
发起方
入组人数
100
试验地点
1
主要终点
Depression, Anxiety and Stress Scale - 21 (DASS-21)

研究概览

简要总结

ABSTRACT

Background:

Today, a wide range of pediatric cancers is treated by chemotherapy. More than 21 side effects of chemotherapy have been identified. Among those nausea; vomiting, infection and anemia are most common. The adverse effects are normally managed by the parents at home. Ineffective coping and lack of knowledge about chemotherapy side effect management leads parents stress. Contemporary research evidence that Nurse-led education, booklet providence and follow up about chemotherapy and side effect management, help to decrease parents anxiety and depression.

Objectives:

To measure the effect of nurse-led multimedia education, booklet providence and telephonic follow up about chemotherapy and side effects management on parents anxiety and depression of children receiving chemotherapy for the first time.

Methodology:

A randomized control trial will be conducted in the department of chemotherapy at Indus Children Cancer Hospital Karachi from March 2018 to August 2018 on parents of children below 18 years of age undergoing chemotherapy for the first time. Total 100 parents will be randomly divided into Intervention group (n=50) and Control Group (n=50). The Intervention group will received multimedia education, booklet and weekly tele-nursing follow-up about chemotherapy and side effects management. The Control group will receive routine care. Parent's anxiety and depression will be identified by using DASS-21 and generalized estimating estimation will be used to analyzed the data.

Keywords:

Nurse-led, Multimedia education, Booklet, telephonic follow-up, chemotherapy, side effects, parents, anxiety, depression, children, cancer

详细描述

INTRODUCTION Background Children Cancer in Pakistan: Millions of people are affected by cancer worldwide. Cancer is one of the major health problems in Pakistan . About 8,000 children below 18 year were diagnosed with cancer annually. Most children diagnosed in advance stage . In Pakistan 31% children had leukemia, 20% had Lymphoma, 08 % had sarcoma, 8 % had bone tumor, 7% had brain tumor, 6 % had retinoblastoma, 5 % had wilms tumor, 4% had germ cell tumor, 4 % had neuroblastoma and the other had 7 % .Cancer affects family emotionally and physically.

Chemotherapy and side effect: Millions of people are also facing difficulties due to chemotherapy worldwide. If the patient will not prepare for chemotherapy treatment properly he/she can face problem in future .Chemotherapy is the common method of treatment. The common side effects of chemotherapy are diarrhea, nausea and vomiting, hair loss, neuropathy, weight loss, dysphagia, oral ulcer, fatigue, dyspnea, constipation, insomnia and cognitive impairment, also affects quality of life, economic conditions, emotions and social wellbeing. Before starting chemotherapy treatment the patient should receive written information about diagnoses, treatment goal, chemotherapy duration, side effects of drugs, the material should design at the level of patient knowledge.

Cancer vs anxiety depression: The anxiety is due to unawareness about chemotherapy side effect. 47% victims of patient have anxiety due to cancer . The power to control disease can be lost due to anxiety .Side effect of chemotherapy management required self-care and it is can be effect due to depression. Anxiety and depression has an association with cancer, chemotherapy related fatigue, lack of education about chemotherapy side effect management and long term exposure of children in hospital . Cancer treatment required nursing intervention to reduce anxiety and depression . Anxiety leads to delay chemotherapy treatment and prognoses.

Evidences of Multimedia education to reduce Anxiety and depression: It is the main responsibility of Oncology nurse to educate patient about the management of side effect of chemotherapy but mostly patient received written material only. The recommended practice to reduce anxiety of patient is to educate about side effect of chemotherapy. The patient should be education both for short term management and long-term management. Education about side effect helps to decrease anxiety. The effect of multimedia education to reduce anxiety is evident in mammography, MRI, ECT, cardiac surgeries, gynecological laparotomy, laparoscopic cystectomy, hemodialysis, teeth removal and peptic ulcer disease. Nursing intervention through education helps to reduce anxiety and stress , after chemotherapy, promote side effect management, decrease complications and increase psychological wellbeing. Many resource centers for patient education on cancer are available on internet about chemotherapy and side effect to increase the psychosocial health. The resources can be utilized as a part of continuous nursing education.

Anxiety and depression in Pakistan: Anxiety and depression is more common in Pakistan due to lack of infrastructure for mental health services.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Care Provider)

入排标准

年龄范围
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Parents along with their Children younger than 18 years of age Note: (Here Child age was taken as Inclusion criteria for Parents, because child age is evident for impact on Parents Psychology, in local study no association of Parents age was evident)
  • •Parents along with their children newly diagnosed with cancer in last three weeks
  • •Parents along with their children schedule to receive first time chemotherapy in the outpatient department

排除标准

  • •Parents along with their children refused to participate
  • •Parents along with their children already receiving interventions like multimedia education, booklet providence and telephonic follow up for chemotherapy and side effect management
  • •Parents taking medicine for their anxiety and depression. (e.g. Anxiolytics/ Antidepressant)
  • •Parents showing uneasiness and discomfort during educational session.

研究组 & 干预措施

Intervention

Experimental

The Intervention group will received multimedia education, booklet and weekly tele-nursing follow-up about chemotherapy and side effects management

干预措施: Multimedia education, booklet Providence and tele-nursing follow-up (Other)

Control

No Intervention

The Control group will receive routine care

结局指标

主要结局

Depression, Anxiety and Stress Scale - 21 (DASS-21)

时间窗: up to 4 weeks

DASS-21 is comprised of questionnaires for three separate scales measuring Depression, Anxiety and Stress. The depression scale is scored by summing the responses of each question, multiplying by 2 and then scoring on a scale ranging from a minimum of 0 to a maximum of 28+, with higher scores indicating greater severity. The anxiety scale is scored by summing the responses of each question, multiplying by 2 and then scoring on a scale ranging from a minimum of 0 to a maximum of 20+, with higher scores indicating greater severity. The stress scale is scored by summing the responses of each question, multiplying by 2 and then scoring on a scale ranging from a minimum of 0 to a maximum of 37+, with higher scores indicating greater severity

次要结局

未报告次要终点

研究者

发起方
Nomi Waqas Gul
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Nomi Waqas Gul

Principal Investigator

Dow University of Health Sciences

研究点 (1)

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