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临床试验/NCT04297982
NCT04297982已完成不适用

The Effect of Mandala Activity on Psychological Symptoms, Anxiety and Depression Level of Adolescents Receiving Cancer Treatment

Akdeniz University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年3月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Memorial Symptom Assessment Scale Psychological Sub Dimension

研究概览

简要总结

Aim: The aim of this study is to determine the effect of mandala activity on adolescents receiving cancer treatment on psychological symptoms and anxiety/depression level.

Method: The study was conducted as a randomized controlled experimental study with adolescents aged 12-17 years receiving cancer treatment in Akdeniz University Hospital Pediatric Hematology and Oncology Clinic. The sample group was composed of 30 adolescents in the experimental group and 30 adolescents in the control group using the closed envelope system in accordance with the selection criteria of the sample. The experimental group was given 2 sessions of mandala drawing and staining activity with music at least 48 hours apart. In the study, individual activity was preferred. In each session, adolescents were allowed to draw and stain a mandala. 'Data Collection Form' before the first session, 'Memorial Symptom Assessment Scale', ''Hospital Anxiety and Depression Scale were applied to the experimental group before and after the first session. The same data collection tools were applied to the control group at 48 hours intervals without any activity.

详细描述

Type of the Study This research; This is a randomized controlled experimental study to determine whether mandala activity applied to adolescents receiving cancer treatment has an effect on psychological symptoms and anxiety / depression level.

Place and Time of the Study The research was carried out in Antalya Akdeniz University Hospital, Child Hematology / Oncology Clinic. The research data were collected by the researcher between March 2019 and February 2020. Akdeniz University Child Hematology and Oncology Clinic is a 32-bed institution where children between 0-18 years old receive inpatient treatment and care. It is forbidden to visit the clinic to protect patients from infection, thereby providing a calm environment in the clinic. The rooms are double and single.

Mandala activity at a normal room temperature (average 25 ° C), in terms of being bright enough and a comfortable environment for adolescents; It was planned to have a room that was spacious, clean, with a window opening (not opening to the corridor) and in sunlight, and it was decided that the most suitable environment in the clinic was the patient's own room.

Sample of the Research The sampling of the study was composed of all adolescents who received cancer treatment in Akdeniz University Hospital Child Hematology / Oncology Clinic. Adolescents who accepted to participate in the study on a voluntary basis and having the inclusion criteria constituted the sample of the study. The sample group was formed in accordance with the sample selection criteria and divided into two as experimental and control groups. As a result of the power analysis, the sample group with 80% power and 0.05 error margin; The experimental group 30 and the control group 30 were planned to form a total of 60 children receiving cancer treatment.

Data Collection Tools In this study; Two scales were used for the descriptive features of the Personal Information Form, Memorial Symptom Evaluation Scale Psychological Sub-Dimension (MSDÖ-P) and Hospital Anxiety and Depression Scale (Adolescent Age Group Form).

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 (Participant)

入排标准

年龄范围
12 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Must be able to read and speak Turkish
  • Clinical diagnosis of cancer disease
  • The ages of 12-
  • The duration of diagnosis is at least 2 months
  • Must be have cancer treatment,

排除标准

  • The patient is in the terminal period

结局指标

主要结局

Memorial Symptom Assessment Scale Psychological Sub Dimension

时间窗: 5 day

Memorial Symptom Assessment Scale is a scale developed by Portenoy et al. In 1994 in order to determine the symptoms experienced by patients with cancer diagnosis in the last week. In 2000, Collins et al. Adapted the scale to adults by carrying out the validity and reliability study of children aged 10-18 years of age. Adaptation, validity and reliability studies were carried out in 2007 by Atay et al. The psychological sub-dimension of the scale was used in the planned study. In this study, Cronbach's alpha value of all items of the scale was determined as .90. The statistically significant increase in the mean score of psychological symptoms in posttest measurement in the intervention group is the success criterion of the study. Significance level is set at p\<0.05 in analyzes. No statistically significant difference is expected in the pretest posttest mean scores of the control group.

Hospital Anxiety and Depression Scale

时间窗: 5 day

Hospital Anxiety and Depression Scale was developed in 1983 by Zigmond and Snaith. The Turkish version of the scale in the adult age group was made in 1997 by Aydemir et al. The application time of the scale is 2-5 minutes. In 2014, Erkan adapted to Turkish culture and language in the 12-17 adolescent age group, and its validity and reliability study was performed. The scale consists of 14 items, it includes the 7-item Anxiety subscale and Depression subscale. In each item, a score of 0-3 is obtained by choosing one of the four-likert type options. The statistically significant increase in the mean score of anxiety and depression in posttest measurement in the intervention group is the success criterion of the study. Significance level is set at p\<0.05 in analyzes. No statistically significant difference is expected in the pretest posttest mean scores of the control group.

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

Meltem Gürcan

Research Assistant

Akdeniz University

研究点 (2)

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