跳至主要内容
临床试验/NCT05457153
NCT05457153尚未招募不适用

Intervention Protocol: Evaluation of the Effectiveness of the Technology-Based Well-Being Process Program (WEBEPROP) for Children and Adolescents in Palliative Care: A Randomized Trial

Gazi University0 个研究点目标入组 60 人开始时间: 2022年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
主要终点
Pediatric Cancer Coping Scale (PCCS)

研究概览

简要总结

Objective: The research was planned to evaluate the effectiveness of the 8-week technology-based Well-Being Process program for children and adolescents in the palliative care period. Methods: This study was planned as a randomized controlled experimental study. The research will be carried out with children aged 12-20 years with a diagnosis of cancer, in the pediatric oncology and hematology clinics of two hospitals in Turkey. Data collection will consist of the children and adolescent's and parents' descriptive characteristic form Adolescent Spiritual Well-Being Scale, Beck Anxiety Scale, Pediatric Cancer Coping Scale and Technology-Based Spiritual Care Program Process Evaluation Forms. The program will be implemented for the intervention group. In the 8-week program; a) 4 web-based modules, b) 8 online individual interviews after each module (8 total interviews with each child) c) simultaneous mobile messages with the modules, and d) 24/7 counseling. Animation videos, breathing and progressive relaxation exercises, and imagination methods will be included in the modules. This research is based on the "Watson Model of Human Care".

详细描述

Hypothesis

H1: There is a significant difference between the spiritual well being score averages of children and adolescents who have been administered and have not been administered WEBEPROP.

H2: There is a significant difference between the anxiety scores of children and adolescents who have been administered and have not been administered WEBEPROP.

H3: There is a significant difference between the coping scores of children and adolescents who have been administered and have not been administered WEBEPROP.

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
Single (Participant)

入排标准

年龄范围
10 Years 至 20 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Between the ages of 10-20,
  • Child and adolescent with palliative care needs
  • At least 3 months before diagnosis
  • Child and adoescent have completed the induction phase of treatment,
  • İntermediate-high-risk group defined under a treatment protocol,
  • Child and aolescent can utilizecomputer, mobile phone and tablet
  • Children and adolescents who agreed to participate in the survey and their parent.

排除标准

  • Newly diagnosed with physical and mental disabilities,
  • Child and adolescent with severe anxiety according to the anxiety score scale,
  • Out of diagnosis in the last 6 months (loss of parents, natural disaster, etc.) are children and adolescents who experience high levels of stress and have an important psychiatric diagnosis that affects their mental health.

结局指标

主要结局

Pediatric Cancer Coping Scale (PCCS)

时间窗: Coping scores will be checked at the beginning of the program "baseline"

The scale developed by Wu et al. for children with cancer between the ages of 7 and 18 years. The Turkish validity and reliability of the scale was conducted by Sengul and Törüner (2019). There are a total of 33 items in the scale. There are three sub-dimensions of cognitive coping, problem-oriented coping and defensive coping. A minimum of 0 and a maximum of 99 points is obtained from the scale. High scores obtained from the scale indicate high levels of coping strategies. A low score means that coping skills are insufficient.In the original study of the scale, the Cronbach Alpha value was determined as 0.91

The Scale of Spiritual Well-Being in Adolescents (SSWA)

时间窗: The Scale of Spiritual Well-Beingscores will be checked at the beginning of the program "baseline"

The scale developed by Törüner et al. assesses the spiritual well-being of adolescents aged 14-18 years. The scale, which is thought to help health professionals provide holistic care for adolescents, consists of a total of 34 items. Adolescents receive a minimum of 0 and a maximum of 136 points from the scale. As the score obtained from the scale increases, the spiritual well-being scores of adolescents increase. As the score obtained from the scale decreases, the spiritual well-being of the adolescents decreases. The Cronbach alpha value of the scale is 90.

Beck Anxiety Scale

时间窗: Anxiety scores will be checked at the beginning of the program "baselıne

The scale, which was developed by Beck et al. in 1988 to determine the level of anxiety (anxiety) of adult and adolescent individuals, consists of 21 items of the four-likert type. The Turkish validity and reliability study of the scale was conducted by Ulusoy et al. in 1993. Individuals are expected to be marked by their intensity of experiencing substances that are composed of symptoms and emotions commonly associated with anxiety. The sum of the scores was evaluated as 0-7: Minimal level of anxiety, 8-15: Mild level of anxiety, 16-25: Moderate level of anxiety, 26-63: Severe level of anxiety

次要结局

  • The Scale of Spiritual Well-Being in Adolescents (SSWA)(The Scale of Spiritual Well-Being scores will be checked completed"through study completion, an average of 1 week")
  • Pediatric Cancer Coping Scale (PCCS)(Coping scores will be checked completed "through study completion, an average of 1 week")
  • Beck Anxiety Scale(Anxiety scores will be checked completed"through study completion, an average of 1 week")

研究者

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

Ebru Kilicarslan Toruner

Professor

Gazi University

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