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临床试验/NCT05982379
NCT05982379已完成不适用

Investigation Into the Impact of Technology-Based Motivation Program Applied to the Children Followed With Cancer Diagnosis and Their Families: A Randomized Controlled Study

Zeynep Kisecik Şengül1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2019年9月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
31
试验地点
1
主要终点
Children's quality of life scores

研究概览

简要总结

Purpose: To determine the effectiveness of the technology-based motivation program implemented with children with cancer diagnosis and their primary caregivers.

Methods: This randomized controlled trial was completed with 31 children and 31 primary caregivers between the ages of 9 and18, who were being treated for cancer. A 10-week "Technology Based Motivation Program" was given to the intervention group. "State/ Trait Anxiety Inventory for Children", "Paediatric Quality of Life Inventory", "Paediatric Cancer Coping Scale", "State and Trait Anxiety Inventory," and "Process Evaluation Forms" were administered. Chi-square test, Fisher-Exact test, Independent Sample-t test, Man-Whitney U test, Wilcoxon test, Pearson and Spearman correlation coefficients were used for data analysis.

详细描述

Design The study was conducted in two hospitals at Leukemia Polyclinic, Paediatric Haematology and Oncology Polyclinic, and Paediatric Haematology-Oncology Service from September 2019 to August 2020.

Setting and Samples In determining the research population, hospital registry information was used, and 119 children followed up with a diagnosis of cancer formed the research population. The sample of the research consisted of 44 children (leukaemia n = 33, solid tumour n = 11) and their primary caregivers meeting the inclusion criteria.

Randomization and blinding A stratified randomization method was used in the research. 44 children (leukaemia and solid tumour) who met the inclusion criteria were grouped according to gender (male and female) and age (9-13 years-14-18 years) and eight layers were obtained. Among the identified strata, intervention and control groups were randomized by an independent statistician using the website www.randomizer.org, 22 children were assigned to the intervention, and 22 to the control group. Five children from the intervention group and five children from the control group (unreachable (n=3), ex (n=1), refusal (n=4), Hematopoietic stem cell transplantation (HSCT) performed (n=1), intensive care unit admission (n=1)) could not be included in the research for various reasons and 34 children were included in the research. The purpose and content of the research were explained without informing the children and their primary caregivers that they were in the intervention or control group.

At the end of the research, the power analysis performed by using the mean scores of State Anxiety Inventory for Children with G * Power 3.0.10 program yielded a total of at least 28 samples that were found to be sufficient with 90% power and 5% margin of error (n1 = 14; n2 = 14).

Theoretical underpinnings The use of models is important in establishing the theoretical framework of research. In this research, the Transactional Stress and Coping Model of Lazarus and Folkman, which is the most widely used model in studies examining the coping and anxiety levels of children with cancer diagnosis, was used. The practices in the motivation program were created for the coping strategies of "seeking social support, self-control, positive evaluation and accepting responsibility" in the model.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

盲法说明

Among the identified strata, intervention and control groups were randomized by an independent statistician using the website www.randomizer.org. The data of the study were entered by a person other than the researcher. Statistical analysis was performed by a person other than the researcher.

入排标准

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

入选标准

  • For children:
  • Those having received cancer treatment (leukaemia, lymphomas and solid tumours),
  • Those aged 9-18 years,
  • Those who speak Turkish,
  • Those who have internet access on their smart phone or computer,
  • Self and primary caregiver having agreed to participate in the study, and
  • Those who can continue the research for 9 weeks (Trying progressive relaxation exercises, breathing exercises and imagination at least twice a week).
  • For primary caregivers:
  • Those who speak Turkish,
  • Those who are literate,
  • Those who have internet access on their smart phones and computers,
  • Those who agree to participate in the research, and
  • Those who can continue the research for 9 weeks (Trying progressive relaxation exercises at least twice a week).

排除标准

  • Those who do not agree to participate in the research,
  • Those who have experienced significant life events in the last 6 months (migration, death, divorce etc.),
  • The presence of another important disease in the family that can increase stress and prevent coping, and
  • Those who do not have internet access.

结局指标

主要结局

Children's quality of life scores

时间窗: baseline (Initial interview) and through study completion (10th week)

Pediatric Quality of Life Inventory: The scale consists of 23 items and is scored from 0 to 100. The higher the score, the higher the quality of life

Anxiety levels of the primary caregivers

时间窗: baseline (Initial interview) and through study completion (10th week)

Spielberger State/ Trait Anxiety Inventory: 20 items of the 40-item scale are used to determine state anxiety and 20 items are used to determine trait anxiety.The scores on the scale range from 20 to 80, and the higher the score, the higher the level of anxiety.

Coping scores of the children

时间窗: baseline (Initial interview) and through study completion (10th week)

Pediatric Cancer Coping Scale:The scale comprises 33 items related to cognitive coping, problem oriented coping, and defensive coping.The score obtained from the scale ranges from 0 to 99. Higher scores on the scale indicate a high level of coping strategies.

Anxiety levels of the children

时间窗: baseline (Initial interview) and through study completion (10th week)

State/ Trait Anxiety Inventory for Children: 20 items for the State Anxiety, 20 items for the Trait Anxiety. The scores on the scale range from 20 to 60, and a high score indicates high anxiety.

次要结局

  • Application tracking forms(Every week during the intervention)

研究者

发起方
Zeynep Kisecik Şengül
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Zeynep Kisecik Şengül

Assistant Professor

Kırıkkale University

研究点 (1)

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