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临床试验/NCT04533776
NCT04533776已完成不适用

Peer-Interaction Group Support in Adolescents With Celiac Disease: A Randomized Controlled Trial

Melike Taşdelen Baş2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2018年6月22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
36
试验地点
2
主要终点
Coping Scale (KIDCOPE)

研究概览

简要总结

This study was designed as a randomized controlled experimental study to examine the effects of peer-interaction group support in adolescents with celiac disease (CD) in the 13-18 age group on the quality of life, friendship relations, and coping levels of adolescents.

Six peer interactive group sessions were held with one week intervals with adolescents (n = 18) in the study group included in the sample for a period of 3 months. In the sessions, all participants were asked questions about the purpose of the session and a discussion environment was created. No training and counseling were provided to the adolescents in the control group (n = 18). Before and after the peer interactive group support, adolescents in the intervention and control group were asked to complete the quality of life, friendship qualities, and coping scales.

详细描述

The study is a randomized controlled experimental study conducted to examine the effect of peer interactive group support on quality of life, peer relationships and coping (coping) levels in adolescents aged 13-18 years with celiac disease.

The study was conducted on adolescents with a diagnosis of celiac disease in the outpatient clinic of the Department of Child Health of Afyon Kocatepe University in Afyonkarahisar. This change took place after research permissions were obtained. Patients are served in the polyclinic between 09:00 and 17:00 on weekdays. Gastroenterology Specialist, who monitors the patients with Celiac diagnosis, works as a physician. There are no nurses in the polyclinic and individual training is not given to celiac patients according to their needs.

There are 85 patients with a diagnosis of celiac disease in the 0-18 age group who were followed up in the Department of Child Health and Diseases of Afyonkarahisar Health Sciences University, where the study will be conducted. It was determined from the patient records that there were 36 patients with a diagnosis of celiac disease in the 13-18 age group. The universe of the study consisted of patients with a diagnosis of celiac disease in the 13-18 age group who were followed up in the Pediatric Outpatient Clinic of Afyonkarahisar University of Health Sciences.

Data Collection Tools Introductory Information Form, Quality of Life Scale for Children (13-18 age group), Friendship Qualities Scale and Coping Scale for Adolescents prepared by the researcher for data collection.

Introductory Information Form In this form prepared by the researcher, there are 14 questions regarding the demographic characteristics of the mother, father, family and child. After randomization, an introductory information form (before peer interactive group support) was administered to all adolescents in the research and control groups in a classroom of the Pediatric Outpatient Clinic where the study was conducted.

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

入排标准

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

入选标准

  • Must have had celiac disease for more than a year
  • Must be between 13-18 years old

排除标准

  • Another chronic disease
  • Psychiatric illness

结局指标

主要结局

Coping Scale (KIDCOPE)

时间窗: 12 weeks

Coping Scale for Adolescents (KIDCOPE) The scale, which was created by Spirito et al. (1988) under the name of KIDCOPE (multidimensional coping strategies for children scale), consists of two forms for children (5-13 years old) and adolescents (13-18 years).The scores to be scored range from 0-12 for active and avoidant coping, and 0-9 points for negative coping. A higher score indicates that the assessed coping approach is used more.

Friendship Qualities Scale

时间窗: 12 weeks

Friendship Qualities Scale The Friendship Qualities Scale aims to evaluate the relationship of children and adolescents in the 10-18 age group with their best friends. The scores that can be obtained vary between 4-20 in the Togetherness, Conflict and Protection sub-dimensions, and 5-25 in the Assistance and Proximity sub-dimensions. If the scale score to be obtained from both the total score and the sub-dimensions is high, this is considered as positive peer relationships.

Quality of Life Scale

时间窗: 12 weeks

The Quality of Life Scale for Children (PedsQL) is a scale suitable for use in healthy or ill children and adolescents in settings such as schools and hospitals. The scale consists of 23 items in total. The scale is in the form of a 5-point Likert scale and is scored between 0-4. The items are scored between 0-100. It is thought that the higher the total score for PedsQL, the better the health-related quality of life.

次要结局

未报告次要终点

研究者

发起方
Melike Taşdelen Baş
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Melike Taşdelen Baş

Lecturer, Dr.(Nursing Department)

Selcuk University

研究点 (2)

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